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Outcomes measurement and diagnostic assessment






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Bemhard Aicher. Achim Muller*, Heidemarie Beck, Dept. of Med. Sciences, Boehringer Ingelheim Pharma KG, D-88397 Biberach, Gel-many, H.-C. Diener, Neurologic Clinic, Univ D-45122 Essen, V. Pfaffenrath*, D-80802 Munchen

Aim of Investigation: To introduce a new primary endpoint in clinical trials to evaluate the efficacy of analgesics.

Methods: Today's state of the art endpoints are based on Visual Analogue Scale (VAS) or Verbal Rating Scale (VRS) data reported in patient diaries at fixed timepoints: Sum of pain intensity differences (SPID) or SPID weighted, total pain relief (TOTPAR), 50% pain relief at a fixed timepoint (e.g., 1 or 2 hours after administration), or onset of action (determined by means of a stop watch). For the patient, both a relevant pain relief and the time until its onset are important. Therefore, the new approach of calculating the time until 50% pain relief on the basis of pain intensities reported at fixed timepoints combines the advantages of the above methods.

Results: In a double-blind, randomised, placebo-controlled, mul-ticenter, 6-arm clinical trial in parallel group design with antipyretic analgesics in 1 500 patients with common migraine and episodic tension type headache (according to IHS (International Headache society) classification), the new approach led to a reduction in the required sample size by more than 25%, as compared with the classical endpoints such as SPID weighted, pain relief after 2 hours, percentage of patients with at least 50% pain relief after 30 minutes, 1, 3, and 4 hours, etc. The statistical methods such as confirmatory analysis using Kaplan-Meier estimator and log rank test are discussed.

Conclusions: The new primary endpoint results in advantages in trial conduct and in a considerable reduction in the required sample size.


CA Alcencio. TY Lin, HFG Barboza, MJ Teixeira, MA Romano, J Vorobow, CO Guedes, R Mattar Jr, RJ Azze, Pain Clinic, Division PM &R, Univ ofSao Paulo Medical School, Rua. Conselheiro Brotero, 1539, cj 12, Cep 01232-010, Sao Paulo, Brazil.

Aim of Investigation: Evaluation of disability, mood, pain intensity and quality of life (QOL) in patients with WMSD. Methods: The quality of life and the functional assessment of 50 WMSD patients (92.3% female) were performed through a self report specific protocol, including the evaluation of physical functioning, psychological status, social behavior, disabilities, daily activities, professional conditions and concurrent symptoms.

Results: 78.4% of the patients considered pain very incapacitating, 50% considered fatigue extremely intense, 40.5% poor sleep, 45.9% severe depression, 35.1% very important financial difficulties, and 40.5% intense incapacity for work. 40.5% of the patients considered themselves not dependent on medications for pain control, 35.1% felt helplessness, and 18.9% had self-esteem reduction. Leisure was abolished by 35.1% of patients. 8.5% of them were working and 23.4% were adapted for the former job. 63.2% of the patients used the affected limb in more than 50% of daily activities.

Conclusion: WMSD affected the individuals in a multifaceted way. The rehabilitation program should focus the complex psychological, social, legal, medical and physical aspects of pain and disability. The assessment of QOL and functional capacities is very important to design the appropriate rehabilitation program in patients presenting WMSD.


Karen O. Anderson. Tito R. Mendoza, Cindy DeLeon, Charles S. Cleeland, Pain Research Group, WHO Collaborating Center in Supportive Cancer Care, Univ of Texas M.D. Anderson Cancer Center, Houston, TX, 77030 USA

Aim of Investigation: Our research has shown that underserved minority patients with advanced cancer are at risk for under treatment of cancer-related pain. The aim of the present study is to explore the relationship of pain to other cancer-related symptoms and quality of life in minority cancer patients. It is hypothesized that pain will be significantly associated with other symptoms. It is also predicted that symptom intensity and interference will be significantly correlated with quality of life.

Methods: The subjects were 100 underserved African American and Hispanic cancer patients. The cancer-related symptom inventory developed by the Pain Research Group was used to measure symptom intensity and symptom-related interference in areas such as work, sleep, and relations with others. The subjects also completed the SF-36 Health Survey to assess overall quality of life. Demographic and clinical data (e.g., diagnosis, disease stage) were also collected.

Results: The mean number and intensity of cancer-related symptoms will be determined. The patients' pain intensity levels will be correlated with other symptoms (e.g., fatigue, nausea, distress). Analyses will determine if symptom severity varies according to level of pain (i.e., mild, moderate, severe). Pain and symptom severity also will be correlated with quality of life scores. In addition, the patients' pain and symptom levels will be compared to those of a sample of 100 non-minority cancer patients.

Conclusions: Understanding the relationship of cancer-related symptoms to pain is essential for optimal treatment planning. Minority patients who are at risk for poor pain management may be at risk for other under treated symptoms that impact quality of life. Acknowledgments: Supported by the U.S. Army Medical Research and Materiel Command under DAMD17-94-J-4233, PHS Grant CA64766 from the National Cancer Inst, and SIG #21 from the American Cancer Society.


V. Bachiocco*. A.L.Suman**, F. Baldi, W.C. Clark , G. Carii**, Dept. of Anaesthesia and Reanimation S. Orsola, Bologna, Italy*;

Dept. of Psychiatry, Columbia Univ, New York, USA^, Inst of Human Physiology**and Rheumatology, Univ of Siena, Italy.

Aim of Investigation: To prove the validity of an Italian language version of MAPS, studying its construct and concurrent validity.

Methods: MAPS was translated from English into Italian language by two lingual experts. This version (MAPS It) was then administered to 99 (age 44.8±11.6; 10 M, 89 F) outpatients suffering from fibromyalgia and musculoskeletal pain. At the same session patients completed also the following questionnaires: State Trait Anxiety Inventory-Y (STAI-Y), Symptom Check List-90 (SCL-90) and Pain Locus Control (PLOC) scale.

Results: Cluster analysis was applied to explore the latent structure ofMAPS-It. Statistical processing showed a structure very similar to the original one. The main category dimensions sensory qualities, suffering, well being were in fact fully replicated. Pearson correlation proved significant relationships between MAPS-It sub-categories and STAI-Y, SCL-90 and PLOC sub-scales e.g. affilia-tive feelings and positive affect and STAI-Y (r = -0.342, p>0.005; r = -0.48, p>0.005 respectively), mental activities and SCL-90 depression (r = -0.36, p>0.005), depressed mood and PLOC chance (r = 0.34, p>0.005).

Conclusions: Results support the validity of MAPS-It.


Jane Ballantyne. Shobana Chandrasekhar, Lauren Peters, William R. Kimball, MGH Pain Unit, Massachusetts General Hospital, Fruit St. Boston 02114, USA

Aim of Investigation: To explain why some clinical tnals fail to confirm that pulmonary function is improved when pain control is optimized, despite the strong clinical impression that good analge-sia improves pulmonary function. To test the hypotheses: (1) that pain severity during maximal effort is a better correlate of pulmonary dysfunction than is pain severity at rest, (2) that decreases in maximal and sustained inspiratory and expiratory pressure are better correlates of pain severity than arc decreases in lung volume or expiratory flow.

Methods: Forced expiratory volume in one second (FEVi), forced vital capacity (FVC), peak expiratory flow rate (PEFR), peak expiratory pressure (PEP), peak inspiratory pressure (PIP) and visual analogue pain scores (VAS) at rest and during maximal effort (during pulmonary function testing (PFT)) are measured preopera-tively and for three days postoperatively in a preliminary group of 15 patients undergoing upper abdominal surgery.

Results: Pain at rest (VAS) correlates with PFTs as follows: (Pear-son Correlation Coefficients): FEV, 0.41 (p=0.03), FVC 0.21 (p=0.29), PEFR 0.48 (p=0.01), PEP 0.28 (p=0.15), PIP 0.23 (p=0.25). Pain during maximal effort correlates in the following manner: FEV, 0.38 (p=0.01), FVC 0.12 (p=0.42), PEFR 0.45 (p=0.0019), PEP 0.24 (p=0.1), PIP 0.18 (p=0,22).

Conclusions: (1) Pain during maximal effort does not appear to be a better correlate of pulmonary dysfunction than pain at rest. (2) The best correlation between measures of pulmonary function and pain severity is seen with FEV, and with PEFR. Pain at rest, lung volumes and expiratory flow appear to be valid measures in studies relating pain to pulmonary function.


Niels Becker. Per Sjegren, Per Bech, Alf Komelius Olsen, Jergen Eriksen. H:S Multidisciplinary Pain Center, National Hospital, DK-2200 Copenhagen, Denmark.

Aim of Investigation: To investigate the effect of outpatient multi-disciplinary pain treatment (MPT) compared with treatment by a general practitioner after initial supervision by a pain specialist (GP-group) in a randomized controlled study. The control group consisted of patients on a 6-months waiting list (WLC).

Methods: One-hundred-and-eighty-nine chronic non-malignant pain patients were studied. At referral, and after 3 and 6 months patients filled in questionnaires evaluating pain intensity, health related quality of life (HRQL) and use of analgesics. HRQL was evaluated using the Medical Outcome Study-Short Form (SF-36), the Hospital Anxiety and Depression scale (HAD) and the Psychological Genera] Well-being Scale (PGWB).

Results: After 6 months patients allocated to MPT (N=63) reported statistically significant reduction in pain intensity (VAS-score, P < 0.001) and improvement in psychological well-being (PGWB, P < 0.001), quality of sleep (P < 0.05) and physical functioning (SF-36-PF, P < 0.05). No improvements were obtained in the GP-group (N=63). In the waiting list group (WLC-group; N = 63) a statistically significant deterioration was observed in PGWB-scores, HAD-scores and in 5 of 8 SF-36-subscores (P < 0.05). A reduction in use of on demand opioids was obtained only in the group receiving MPT ( P=0.001) but in both intervention groups a decrease in the use of short acting opioids was observed (P < 0.01). No change in use of analgesics was seen in the WLC-group.

Conclusion: The present randomised study showed that patients treated at a Multidisciplinary Pain Center (MPC) obtain a significant reduction in pain intensity and improvement of HRQL compared to non-treated patients, and (ii) the mere establishment of a pain diagnosis and a pain management plan by a pain specialist was not sufficient to enable the referring GP to manage the often severely chronified pain patients.


Norberto Bilbeny. Hugo Salinas*, Lorena Llorente*, Boris Araos*, Claudio Tapia*, Ingrid Behrens*, Carlos Paeile, INMED, Santiago, Chile.

Aim of Investigation: To evaluate the preliminary results of the first outpatient multidisciplinary pain program in Chile at discharge.

Methods: 23 patients (16 women, 7 men) were admitted to the outpatient multidisciplinary pain program of 4 weeks of duration, for the months of August to December of 1998. We reviewed the medical and psychosocial history, and current diagnoses at the time of admission. The next measurements were compared by means of pre and post treatment: intensity of pain by numeric rating scale (0-10); oswestry questionnaire (total score: 50); aerobic capacity (VO; max); strength tests (upper extremity and abdominal flexors: repetitions per minute); graphic rating scale of suffering (0-10); questionnaire of emotional symptoms (total score: 85) and questionnaire of psychosocial areas affected by pain (total score: 50). The statistical evaluation was performed by paires t-student.

Results: The main diagnoses in decreased order were the following: chronic low back pain (13), chronic myofascial pain syndrome (12), fibromyalgia (7), chronic headache (2), chronic neuropathic pain (2) and others (2). The mean age was 54 (range from 25-79). The duration of pain was more than 1-year (19) and more than 6 months until 1 year (4). It was found that all data analyzed had statistical significance (p< 0.01) in improving the evaluated measurements.

Conclusions: This preliminary study shows the effectiveness of ambulatory multidisciplinary pain program at discharged in: pain reduction, to increase the level of physical activity and to improve the psychosocial areas evaluated. However, these results must be evaluated in the long term and to consider other aspects, such as: use of health care system, return to work, decrease the consumption of medications and cost-effectiveness.


Christopher Centano. Nancy O. Hester, Julaluk Baramee*, Trauma Care IPA & Univ of CO, Denver, CO 80246, USA

Aim of Investigation: The aim of this study was to describe pain outcomes that patients reported during clinic visits and to determine whether pain outcomes were related to other variables such as functional status. A secondary question focused whether patients had engaged an attorney and if so, why.

Methods: Patients who saw TraumaCare IPA chiropractors and physiatrists completed a questionnaire using a hand-held computer. Questions pertained to pain, functional status, satisfaction with care, knowledge of condition, work status, and engagement of an attorney.

Results: Patients (n=l 89) having at least two clinic visits were included in the analysis. Sixty four percent of the patients were women. Although women reported longer pain duration than men, there were no differences in other pain characteristics including intensity and frequency. Pre and post measures of worst and least pain scores, pain duration, and pain frequency were significantly (a=.05) but moderately correlated (.25 to .49). Most patients (78%) had more than one pain site. Patients with more pain sites experi-enced significantly more pain intensity, longer duration, and higher frequency. More pain sites also affected functional status. Patient's knowledge of their condition did not affect pain measures, rate of recovery, or satisfaction. Fifty percent of the patients had an attorney. The most frequent reason for engaging an attorney was having problems with insurance such as access to care and reimbursement.

Conclusions: This exploratory study provides insight into the patients' experiences with whiplash. Pain is a major problem often affecting more than one area which in turn alters functional status, an important outcome in the recovery from whiplash. The finding regarding "why patients get an attorney" suggests that care access and reimbursement issues are a primary consideration. Further, this preliminary study demonstrates the promising role for the use of clinical databases both in the care of the patient but also as a research tool.


L. Cossins. S. Benbow*, JR Wiles. The Pain Research Inst, Rice Lane, Liverpool L9 1AE, UK.

Aim of Investigation: The study set out to compare treatment outcomes of young and elderly patients.

Methods: All data were collected by means of questionnaires filled in by both patients and doctors. Pain intensity, disability, depression and anxiety were measured using psychometric questionnaires for all patients at presentation and discharge. Pain intensity was also measured using a Visual Analogue Scale (VAS).

Results: 2348 patients were included in the study. 337(14%) were referred to a pain management programme. 696(35%) were discharged after > 1 visit. 81% were <65 yrs., 19% were >=65 yrs.; the mean age in the >= 65 yr group was 72.8(SD 6.0) and in the <65 yr group, 45.0(SD 11.3). The proportions of commonest diagnostic groups was different in the young and elderly (p<0.0001). 31% of elderly and 9% of young patients had face pain and 35% of elderly and 65% of young had spinal pain (p<0.0001). In both groups there was no change in anxiety and depression mean scores at presentation and discharge. However, there is a significant fall in mean pain intensity scores (p<0.0001). In the elderly there is no fall in disability scores (p=0.06) whilst there is in the young group (p=0.002). However, in a direct comparison of elderly and young patients there are no differences in % fall in all test scores from presentation to discharge. There is also no difference in % fall in VAS scores for young and elderly in diagnostic cohorts. 25% of elderly and 18% of young had a 50% or greater fall in VAS scores (NS).

Conclusions: There is no difference in outcomes of young and elderly patients attending a large pain clinic.


U. Damzog, M. GoBmann, R. Klinger, F. Krug, B. Dahme & H.-P. Bruch (SPON: M. Pfingsten), Dept of Psychology 111, Univ of Hamburg, Germany; Dept of Surgery, Medical College, Univ ofLiibeck, Germany

Aim of Investigation: The aim of this work was to develop, within the framework of outcome research and quality assurance, a standardised practical pain and state of health inventory for the peri-operative phase. Various surgical techniques, anaesthetic procedures and pain therapies, along with their effects upon the patient (e.g., impairment) can be recorded and compared.

Methods: The questionnaire records: (1) subjective experience of pain; (2) subjective state of health; (3) physical condition (mobility, nutrition, pulmonary function) and (4) the obligatory objective rating of the general condition by the doctor. The questionnaire was developed in three stages: (1) a first draft that was tested on 20 patients; (2) revision based on those results and a survey of the main data, preoperative and postoperative (1.- 5./last postoperative day in hospital), of 111 patients; (3) renewed revision based on the results of the main examination.

Results: statistical evaluation shows that nearly all pain related items were in 95% of cases answered, well understood, and sensitive to fluctuation. The state of health questions showed similar results (quota of answers 94%). Although the mean values were in the lower third of the scale they proved to be sensitive to fluctuation. In relation to physical condition two items had to be altered to avoid misunderstandings. The "objective" parameters (pulmonary function) proved to be very sensitive to fluctuation. The objective estimation of the doctor showed an error rate of 58% and placed in doubt the value of the routine use of standard clinical procedures. These were retained, however, as optional items.

Conclusions: The questionnaire has made it possible to incorporate a differentiated recording of the experience of pain and psychological and physical condition into the daily routine. It provides a practical instrument for the comparative research of different therapeutic procedures and, in doing so, ensure quality.


Sunil Dogra', Beth Hahn*2. Susan King-Zeller*'. 'Anesthesiology Pain Management Center, Univ of North Carolina, Chapel Hill, NC 27599, USA; 'Glaxo Wellcome Inc, Five Moore Dnve, RTP, NC 27709, USA.

Aim of Investigation: To evaluate the impact of chronic pain on quality of life and aspects of daily living. Methods: A postal survey sent to a random sample of 500 members of the American Chronic Pain Association (ACPA) contained: a general questionnaire assessing pain symptoms, demographics, and economic impact; the Medical Outcomes Study (MOS) Short-Form 36 (SF-36) quality of life questionnaire; MOS Sleep Scale; and MOS Cognitive Function Scale. MOS scores were transformed to a standard scale, ranging from 0 (worst) to 100 (best).

Results: The response rate was 47% (N=236). Nearly all respondents (99%) had chronic pain in the past week; 86% had pain daily. Mean SF-36 scores compared with normative scores were significantly lower (pO.001) in all domains.

Domain ACPA US Norms
Physical Functioning 38 84
Role Physical 10 81
Role Emotional 38 81
Social Functioning 45 83
Bodily Pain 30 75
Mental Health 54 75
Vitality 29 61
Genera] Health 39 72

Mean scores on the Sleep Scale indicated severe impairment for sleep initiation, maintenance, adequacy, somnolence, and sleep quantity. Mean scores on the Cognitive Function scale also indicated impairment.

Conclusions: These results demonstrate that chronic pain severely affects all aspects of quality of life. Monitoring quality of life issues in patients with chronic pain will allow health care providers to assess the adequacy of treatment. A pre- and post-treatment self-administered questionnaire should be used to assess outcomes. This will result in development of an outcomes evaluation system to identify useful diagnostic and therapeutic interventions.


Roxie Foster. The Children's Hospital, Denver, CO, 1056 E. 19th Ave., Denver, CO, USA 80218; James Vami, Children's Hospital and Health Center, San Diego, CA, USA. Aim of Investigation: To develop and conduct initial validation of instruments to measure child and parent satisfaction with pain management.

Methods: From among children who had undergone surgery at two large treatment centers, a convenience sample of 50 parents and 50 children, 8-12 years of age, were selected to complete the satisfaction questionnaires.

Results: Construct validity was well supported in analyses across instruments (concordance in parents' and children's responses) and within instruments (testing of predicted inter-item relationships). Children were much less satisfied with pain management than their parents and differed from their parents in suggestions for improving care.

Conclusions: Although additional validation is required, the parent and child satisfaction instruments performed well in this first study. The findings underscore the importance of measuring satisfaction with a comprehensive instrument and including children's opinions in evaluations of their care. This research is important for its contribution to the scant knowledge of parent-child satisfaction with postoperative pain management and for the development of promising measurement instruments.

Acknowledgments: Supported by a grant from Abbott Laboratories, Hospital Products Division.


P. Gazerani'*. Z. Pourpak2, A. Ahmadiani', 'Dept. Pharmacology, Shaheed Beheshti Univ. Med. Sci.; ^ept. Clinical Immunology, Medical Center for Children, Tehran Univ. Med. Sci. Tehran, Iran.

Aim of Investigation: Determination ofhistamine concentration is a necessary for studying the relation between histamine and migraine pathology. Since the well known flourimetric method for histamine measurement in diagnostic laboratories, need at least 10 ml of whole blood and the measurement must be done in the sampling time, it was tried to introduced a modified method without this restrictions.

Methods: 40 healthy volunteers were used and their blood histamine measured with two different way, the original and modified methods. Only 2 ml of blood (its serum) were used in modified method and perchloric acid was added to deproteinate the samples. Samples were deposited in -20°C in both methods. Results: The histamine concentration was equal for the two different methods in sampling day. Histamine concentration reduced in days 7 and 14 after sampling in original method, but about the modified method, it was constant in days 0 , 7 and 14 after the sampling.

Conclusions: The results showed that it is possible to use only 2 ml of blood, in modified method, instead of 10 ml in original method that specially is not possible in children. The original method need a large volume of expensive materials, so the new method is low cost in comparison with previous method. In addition, determination ofhistamine in sampling day is already difficult and impossible; and the modified method allow us to determine histamine concentration until at least 2 week after sampling. So with this improvement, the measurement ofhistamine with a little amount of serum and after 14 days of saving is possible.


Marielle Goossens. Maureen Rutten', Johan Vlaeyen, Sjefvan der Linden'. Inst for Rehabilitation Research, P.O. Box 192 6430 AD Hoensbroek, The Netherlands.

Aim of Investigation: Economic evaluation is attracting increasing attention as a tool to inform policy makers, insurers and other payers of the value of existing and new treatment modalities. Routine data bases compiled by insurance companies, hospitals and other health care institutions are commonly applied. In order to yield comprehensive resource use data, we at least partly depend on respondents' recall for collecting costing data. A patient cost diary was developed in order to estimate total resource use, expenses and lost production due to illness and treatment. Methods: We applied the cost diary in two randomised clinical trials evaluating the cost-effectiveness of behavioral rehabilitation in 205 fibromyalgia and chronic low back pain patients. Patients were asked to complete the diaries for a period of one year after treatment. The use of the diary was evaluated by studying the feasibility, the influence of three periods of data collection (one complete year, 2 weeks every 2 months, and 3 months in one year) on the distribution of the costs, and some aspects of construct validity, by comparing some diary data with data provided by an insurance company.

Results: The response rate turned out to be 85% and in total 68% of the diaries were returned. No relationship was observed between response rate and relevant characteristics of the patient group. Similar outcomes were found for the three alternative periods of data collection. Finally, self-reported specialist care contacts were generally in agreement with data from an insurance company. However for physiotherapy contacts there were differences between the two data sets.

Conclusion: Taking several supplementations into account, the diary method might be successfully adopted as an instrument to answer cost-effectiveness questions in long-term clinical trials.


S Gupta*. GE Porter*, JMJ Valentine. Pain Management Centre, West Norwich Hospital, Bowthorpe Road, Norwich NR2 3TU, UK

Aim of Investigation: To assess the effects, as perceived by patients and their genera] practitioners (GP), of referral to a supra-regional Pain Management Programme (PMP).

Methods: A total of 25 patients were referred to INPUT (St. Thomas' Hospital, London) and considered suitable for PMP. The 20 patients who completed the programme were sent our questionnaire. We assessed effects on: ability to cope with pain, understanding pain mechanisms, physical activity, social participation, out of house activities, pain medication, GP consultations and quality of life. Each parameter was scored using a 5 point scale, one point indicating no benefit through to five points for maximum benefit. Total score (maximum 40 points) was used to judge overall response, >32 points indicating "Maximal", 25-32 "Moderate", 17-24 "Minimal" and <17 "No" beneficial effect. GP's were sent separate questionnaires assessing changes in patient dependence upon health care services and reduction in medications.

Results: Seventeen patients and 15 GP's responded. Mean duration from completion of PMP to assessment was 11.42 ± 5.75 months. Five patients were judged to have gained "maximum benefit", 7 patients "moderate benefit", 4 patients "minimal benefit", 1 patient "no benefit". Most patients indicated a significantly improved quality of life. GP's survey indicated a reduction in use of health care services, but no notable change in consumption of prescribed analgesic medications.

Conclusions: Our survey indicates that whilst analgesic consumption remains mostly unaltered, Norfolk patients attending the INPUT programme do benefit and gain improved quality of life. Health care services also appear to benefit.


Eleni G. Hapidou. Tanya Anagnostopoulou, Lina Costaki*, loanna Tsimpra*, Sarah Kantartzis*, Chronic Pain Program, Hamilton Health Sciences Corporation & McMaster Univ., Hamilton, ON, Canada, Dept. of Psychology, Aristotle Univ. ofThessaloniki, O.T. School, T.E. L, Athens, Greece.

Aim of Investigation: To develop a Greek Pain Inventory (GPI) with the McGill Pain Questionnaire (MPQ) as the prototype.

Methods: Two independent research groups in Athens and Thes-saloniki, designed studies to generate pain descriptors (adjectives, nouns, or verbs) consistent with the linguistic structure of the Greek language. The Athens group collected data using both an open ended format ("write as many words as possible that describe pain") from 178 subjects, and a closed ended format ("describe your pain from specific pain experiences, e.g. headache, toothache, gastrointestinal pain, menstrual pain, other") from 30 subjects. The Thessaloniki group used the closed ended format with 150 subjects. A total of 358 individuals representative of the Greek population were sampled (Phase 1). The first 178 subjects from the Athens group were also asked to evaluate the relevance of the MPQ translated words in describing pain i Greek.

Results: A list of 230 Greek words was compiled which 70 medical students and nurse practitioners classified as sensory, affective or evaluative (Phase 2), and rated on a 10-point intensity scale (Phase 3). 118 pain words were classified in the three categories by at least 60% of the subjects.

Conclusions: Clinical studies will now be undertaken to establish the reliability and validity of the GPI (Phase 4). We discuss the various theoretical and practical problems we encountered in producing a fully equivalent pain inventory to the MPQ.


Hsiu-Ying Huang. Diana J. Wilkie, C. Richard Chapman, & Lai-Lei Ting*, School of Nursing, Univ of Washington, Seattle, WA 98195-7266, USA; Radiation Oncology Section, National Taiwan Univ Hospital, Taipei, Taiwan 100, R.O.C.

Aim of Investigation: To classify the possible pain etiology for each pain site reported by Taiwanese patients, and to describe patterns of the etiology over the course ofRT for NPC.

Methods: 29 men and 11 women with NPC reported their pain on a pain assessment tool (PAT) prior to and weekly during RT (week 0 to week 7). Each pain site was classified as cancer-induced, treatment-induced, unrelated to cancer/treatment, or unknown cause; and as nociceptive, neuropathic, mixed, or unknown mechanism.

Results: Subjects typically marked 1 to 2 pain sites each week. At week 0, 43% of the pain sites were cancer- induced, and 50% were unrelated to cancer/treatment. Cancer-induced pain decreased to 9% at week 3 and then remained 3%. Treatment-induced pain increased as the RT progressed, ranging from 61% to 86% after week 1. Neuropathic or mixed type of pain was classified for 28% of the pain sites at week 0. During RT, 80% to 98% of the pain sites were nociceptive.

Conclusions: Nearly half of the pains present before RT were caused by cancer, warranting a differential diagnosis as nociceptive or neuropathic and a specific pain relief plan for that type of pain. Cancer-induced pain decreased as the RT progressed, indicating tumor response to RT. About 3 weeks ofRT is likely to eliminate most NPC-induced pain. RT is a significant and dominant cause of nociceptive pain during the treatment, and analgesic therapies for this type of pain should be available to patients.

Acknowledgments: Hester McLaws Scholarship Fund, UW SoN; ONS; STT Psi-Chapter-At-Large; PSONS.


John Hughes. Pain Management Unit, South Cleveland Hospital, Middlesbrough, Cleveland, TS4 3BW, UK.

Aim: To review the outcomes and discharges from a working pain clinic and demonstrate a baseline within one consultant's practice.

Methods: A personal clinic database was reviewed to show the outcomes of intervention within the clinic. These include outpatient, day case and nurse led clinic responses. Since October 1998 subjective outcomes have been assessed by patients filling in a review questionnaire prior to the consultation as improved, the same or worse for pain, sleep, mood and overall. An agreed outcome was recorded at the end of the consultation.

Results: 102 new patients and 219 follow-up or nurse led clinic episodes were recorded. There were 64 discharges of which, 68% improved and 28% remained the same. Half the discharges were directly from nurse led clinics, all were agreed with the patient. Of all the follow-ups, 34% improved, 56% remained the same and 8% got worse. The nurse led clinics fared better with a 51% improving and 45% remaining the same, just over a quarter were returned to the consultant clinic. All 17 patients that got worse returned to the consultant clinic, 4 episodes were with the same patient, 3 have since improved and 10 remain within the clinic.

Discussion: This demonstrates that patients can be discharged with good results and directly from nurse led clinics. The more difficult cases are focused on the consultant out patient clinic. Currently soft data is used but with time objective measures may be added. There is little published data on overall clinic outcomes despite increasing pressures for outcome measures. This is a start showing where we are now in a clinical setting.


Idvall E. Hamrin E*, Rooke L*, Sjostrom B. Dept of Medicine and Care, Division of Nursing Science, Faculty of Health Sciences, S-581 85 Linkoping, Sweden

Aim of Investigation: To evaluate the usefulness of a tentative model, based on important aspects of surgical nursing care, for designing strategic and clinical quality indicators in postoperative pain management.

Methods: Items (fifteen) were designed to be useful as quality indicators in postoperative pain management by using the tentative model as a base and by means of a literature review, e.g. 'the patient's perception of pain must be assessed regularly with the help of a pain assessment instrument', and 'pharmacological pain treatment must be administered preventively'. A questionnaire directed to clinical nurses (n=233) was compiled to elicit feedback on the relevance, face validity, and the usefulness of the items designed for achieving high quality in postoperative pain management.

Results: Fourteen items were assessed as essential for achieving high quality outcomes, eleven as realistic to carry out, and thirteen as possible for nurses to influence with mean scores ^4.0 (on a 5-point scale).

Conclusion: The tentative model combined with a literature search was found to be effective for designing items, which might be useful as strategic and clinical quality indicators in postoperative pain management.

Acknowledgments: Supported in part by The Health Research Council in Southeast of Sweden, The Swedish Foundation for Health Care Sciences and Allergy Research, and Abbott Scandinavia Inc.


J. H. Insuasty. A. Dillenschneider", H. Ganry"- Clinical Research Dpt. - Laboratoires UPSA / Bristol-Myers Squibb Company, Rueil-Malmaison, France.

Aim of Investigation: To explore the relationship between patient' perception of pain relief as measured using the stopwatch method and standard indexes of analgesic activity. Methods : In two double-blind studies, 417 patients with moderate or severe pain following third molar extraction were randomized t receive i.v. propacetamol (PPA) 2g (infusion or injection), oral acetaminophen (APAP) Ig (non-effervescent-NE or effervescent-E) or placebo (P). Time to perceptible pain relief (PPR) and to meaningful pain relief (MPR) were collected using a stopwatch. Pain intensity (PI-100mm vas) and pain relief (PR-5-point verbal scale) were collected at PPR and MPR. Data were analyzed. Results:

Trt Baseline PPR MPR

PPA inf. 58 21.4 1.7 31.2 2.3

(16.9) (14.5) (0.9) (15.1) (0.9)
PPA inj. 59.9 24.3 2.1 34.0 2.4

(14.9) (21.4) (1.2) (18.8) (1.0)
APAP-NE 58.2 16.7 1.3 26.9 2.0

(17.4) (15.8) (0.8) (18.0) (0.8)
P-NE 60.6 26.6 1.9 32.9 1.9

(20.2) (19.3) (0.8) (18.3) (0.8)
APAP-E 48.4 13.7 1.2 26.7 2.2

(9.8) (11.8) (0.6) (13.1) (0.9)
APAP-NE 47.3 11.8 1.1 25.81 2.2

(10.5) (12.0) (0.3) (11.5) (0.76)
P-E 50.5 6.2 0.9 25.4 1.7

(11.3) (10.9) (0.2) (14.4) (0.7)
P-NE 47.6 7.0 0.9 20.9 1.9

(10.2) (9.2) (0.4) (10.7) (1.0)

All values are expressea as mean. * pain intensity difference (VAS)

Conclusion: PPR and MPR as perceived by patients with moderate to severe pain after third molar extraction, correspond respectively to a reduction from baseline PI (VAS) of around 30% and 50% and to a PR (5-point verbal scale) of around 1.4 and 2.2.


Jarkko Kalliomaki and Marcelo Rivano-Fischer, Dept of Rehabilitation, Lund Univ Hospital, 221 85 Lund, Sweden

Aim of Investigation: To perform a retrospective analysis of pain mechanisms in patients that did not improve after surgery intended to relieve their pain.

Methods: The case records of patients referred to the Pain Clinic of the Univ Hospital were searched for with regard to previously performed surgery aiming to relieve a pain condition. All patients had been examined by an interdisciplinary team on the Pain Clinic. Twenty such patients were identified and their case records were then analysed by a pain physician and a psychologist with regard to previous surgery, patient rating of the effect of surgery, pain diagnosis and classification on the Pain Clinic and with regard to the presence or absence of different psychosocial characteristics.

Results: Persisting pain after decompressive surgery for peripheral nerve entrapment of the upper extremity was the most frequent condition (12/20 patients). Six patients had a pain persisting pain after lumbar/sacral nerve root decompression. Multiple operations were common (mean=2.6 operations/patient), especially for upper extremity nerve entrapments. Usually, the long-term effect of surgery was inefficient with regard to pain and in some cases the pain was worsened after surgery. The pain mechanisms in these patients were found to be complex at the time of examination on the Pain Clinic, in some cases possibly already before the decision of surgical therapy was made.

Conclusions: Decompressive surgery of peripheral nerve/nerve root entrapment is assumed to be a first-line treatment of such pain conditions. This study was focused on patients that did not benefit from surgery. Possible reasons for the negative outcome of surgery in these patients and its clinical implications will be discussed.


K. M. Kirkwood. (SPON: J. Bradbury), Barbara Walker Centre for Pain Management at St. Vincent's Hospital, Fitzroy 3065 Melbourne Australia.

Aim of the Investigation: To investigate levels of depression, anxiety and stress using the Depression Anxiety Stress Scale (DASS) in patients referred to an outpatient pain clinic.

Methods: The first 85 English speaking patients, 33 males and 52 females, attending a pain clinic completed the DASS, a 42 item self-report scale and the BDI as part of the assessment procedure.

Results: Mean DASS depression score is 15.54 (S.D.= 12.31);mean DASS anxiety score is 11.27 (S.D. =9.27) and mean DASS stress score is 18.86 (S.D. =11.38). Mean BDI total score is 19.86 (S.D. =11.07).

Conclusions: Patients assessed at this outpatient clinic have moderate levels of depression, anxiety and stress as measured by the DASS. The BDI total score also indicates moderate levels of depression supporting the high correlation previously found between the DASS depression scale and the BDI total score. Although depression has been well researched in pain, the measurement and delineation of stress and anxiety is still a relatively new area of interest. Research analysing the DASS scales and their comparison with other self-report measures will clarify if the DASS is a useful measure of these specific components of distress in patients suffering persistent pain. If so, this is potentially useful in assessment outcome studies as the DASS incorporates measurement of these three affective states in one short questionnaire.


Inger Lindstrom. Inger Bjorkdal, Marcelo Rivano-Fischer, Dept. of Rehabilitation, Lunds Univ. Hospital, 221 85 Lund, Sweden.

Aim of Investigation: To measure changes in quality of body movement patterns (body awareness) of chronic pain patients due to interdisciplinary pain management program, by means of standardised test, Body Awareness Scale-Health (BAS-H, Roxendal, 1987), and to investigate relationship between these results and changes measured with other validated tests, Psychological General Well-Being Index (PGWB) and Multidimensional Pain Inventory (MPI).

Methods: BAS-H consists of 24 items. Each item has 7 scoring points (0 = healthy, vital, relaxed movement; 6 malfunction in movement). 13 items were judged relevant for the study. Formal training in measurement technique is required. BAS-H was gathered from 258 patients by trained physiotherapists (inter-rater reliability higher than 70%). PGWB and MPI were analysed by psychologist. BAS-H, PGWB and MPI were administered first and last week in the program. BAS-H was repeated 8 weeks after discharge, PGWB and MPI were administered at one year follow-up.

Results: Most patients improved significantly their body movement patterns after the program and the improvement was sustained at follow-up. Females, Scandinavian-born patients and patients expected to return to work (according to team judgement before program) had better quality of movement patterns at all three measuring points than other groups. All groups improved at discharge and follow-up. Strong correlation was found between changes in BAS-H and changes in psychological measures.

Conclusions: The study shows BAS-H to be useful to measure changes in body awareness of chronic pain patients due to management program. To our knowledge BAS-H is unique in measuring quality of movement patterns. One year follow-up measurement is planned.


Valerie MacDonald RN BSN, Ann Hilton RN Ed, Karen Kline MSN, Univ of British Columbia & Lions Gate Hospital 231 E 15th St., North Vancouver BC, Canada, V7L 2L7

Aim of Investigation: To evaluate outcomes of a program to manage acute pain in the frail older patient post hip fracture repair; including changes in prescribing practices, nursing assessments, analgesic administration, patient adverse effects and comfort on an orthopaedic unit.

Methods: The program was implemented in 1996 and was based on standards of practice from the geriatric and pain management literature. Activities focussed on reducing barriers to adoption of standards. Education was provided, written and human resources were available to staff, and systems were designed including, preprinted analgesic physician's orders incorporating the standards, and a flow sheet to expedite documentation. A simple interrupted time series design was used to evaluate the program. The charts of 150 patients age 75 and over who had a hip fracture repair were randomly selected and audited for three time periods: 1992, 1995 and 1998. Appropriate prescribing, assessment, analgesic administration and patient comfort were operationally defined and incorporated into the audit tool to enable scoring and comparisons among the groups.

Results: There was a significant improvement in scores of prescribing practices, analgesic administration and patient comfort in the 1998 group. This group received smaller, more frequent analgesic dosing than patients in 1992 and 1995. No difference was observed in adverse effects. Assessments were poorly documented and did not increase in frequency over time.

Conclusions: The program was successful in improving pain management practices and comfort in the frail older patient. Preprinted analgesic orders are an effective means of improving prescribing and administration of analgesics. Pain related documentation was inadequate and warrants further study.

Acknowledgments: Lions Gate Hospital; Univ of British Columbia.


Molloy. M. Nicholas, D. Daymond*, C. Rankin*, S. Tun, C. Brooker, S. Walker and M.J. Cousins. Univ of Sydney Pain Management and Research Centre, Royal North Shore Hospital, Sydney, New South Wales 2065 AUSTRALIA.

Aims of Investigation: To evaluate outcomes on self report questionnaires of function, mood and self-efficacy before and after implantation of a dorsal column stimulator or implantation of an intrathecal pump.

Method: 47 patients completed self report questionnaires of pain, function, mood and quality of life prior to implantation and at varying intervals after implantation.

Results: After implantation of a dorsal column stimulator there was no change in pain ratings but patients reported statistically significant improvements in measures of mood, function and self-efficacy. After implantation of an intrathecal infusion pump patients reported a statistically significant improvement in their usual pain and highest pain but no change in their lowest pain. Patients reported a significant improvement in mood but not in function or self-efficacy.

Conclusions: The small numbers of patients included in this study and large intersubject variability limit the interpretations of the results. The two interventions studied appeared to be associated with different outcomes and the results emphasize the importance of caution in relying on unimodal interventions.


Jan Naslund. Ulla-Britt Naslund*, Thomas Lundeberg, Dept of Physiology and Pharmacology, Karolinska Inst, S-171 77 Stockholm, Sweden.

Aim of Investigation: To investigate the clinical and diagnostic sigris in anterior knee pain (AKP).

Background: AK.P is one of the most common musculoskeletal disorders and is reported to affect 15-33% of the adult population. There has been no consensus on the definition, classification, assessment, diagnosis or management ofAKP.

Methods: Patients with pain from patellofemoral joint during activities involving the ascension and descension and after sitting for long periods were clinically examined. Malalignment was measured by Q-angle. Pain was provoked by peripatellar palpation, passive movement of patella and by compression test. A functional activity score measured function. To exclude anomalies, osteoar-thritis, infection, tumor and apofysitis standard radiographic testing and axial patellar view together with scintigraphy was performed.

Results: 58 patients, 24 men and 34 women, between 19-49 years old, were included in the study. 88% had bilateral pain and had experienced their AKP for 8 years (1-20). 98% of the patients felt pain ascending or descending stairs and 98% when squatting. 81% complained after long periods of sitting. Passive gliding of the patella medially and laterally provoked pain in 53% of the patients. Palpation for pain on the medial border of patella was positive in 45%, lateral palpation in 33%. Compression test was felt painful by 83% and the average Q-angle was measured to 14 (0-25) degrees. Tegner Y's functional score showed low values; 2,6 (light work) and 3,5 (recreational sports).

Conclusion: Patients with AKP experience pain during ascending and descending stairs, squatting and during prolonged periods of sitting. The most pain provoking passive test is the compression test. This test is however also positive in many asymptomatic knees.


M. I. Nemenov*. J. Mikkelsen** (SPON: B.T. Moroz), *St. Petersburg Tech. Univ & Laser Medical Centre, Pavlov Medical Univ, St. Petersburg, 197022-1, RU, **Grundfos A/S, DK-8850, Bjemngbro, DK

Aim of Investigation: Lasers were investigated in order to evaluate their potential for use as standard stimuli in clinic.

Method: Non contact heating by lasers with following wavelengths: 442, 510 & 578, 960, 980, and 1064 nm, was used to assess the cutaneous pain thresholds and other skin sensations. Laser pulses from 5 to 300 ms were used. The diameters of the irradiated area ranged from 150 to 800 [i. Twenty healthy volunteers were tested. The surface temperature was controlled by thermography.

Results: Spatio-temporal distribution of surface temperature was measured for laser operating regimes which evoked threshold pricking pain. The rate of heating was up to 6 °C/ms. The following features were observed: 1 .The short pulses (5-20 ms) heated the skin area smaller than the irradiated area. The pulses of 150-200 ms heated the area larger than the irradiated area. The threshold pricking temperature, with a same rate of heating but different duration of pulses, strongly depended on the pulse duration for pulses up to 100-150 ms. For longer pulses, the threshold temperature could remain constant.

Conclusion: The surface pulse temperature is an indirect parameter of the heat-evoked pain. Heat production in the skin is an objective parameter of laser evoked pain for all types of lasers. Therefore, the surface temperature may be used as an objective parameter of laser-evoked pain for the lasers with the same operating regime and the same wavelength. The surface pulse temperature for pulses more than 100-150 ms can be applied as a feedback parameter for pricking pain. A standard painful stimulus has to be non-damaging and independent of the skin of a subject. The heating by near-infrared diode and CO; lasers depends weakly on the condition of the skin surface. Therefore, they may be suitable for the elaboration of standard laser painful stimuli. However, unlike the laser diodes with wavelengths 960-980 nm, for CO; lasers, the threshold power for evoked skin damage is lower than that for the evoked skin pain, especially for point action.


Shea Palmer'*. Denis Martin', Wilma Steedman', John Ravey2*. 'Queen Margaret College, Duke St, Edinburgh EH6^HF, UK. Psychology Dept, Univ of Ulster at Jordanstown, Shore Road, Newtonabbey, UK.

Aim of Investigation: To investigate the relationship between rate of change of stimuli and thermal thresholds using a method of limits. Thermal testing allows assessment ofA5 and C fibre activity, with limits being one of the most widely used algorithms. The rate of change affects heat pain thresholds due to reaction-time artefact, but this has not been adequately quantified for other thermal thresholds.

Methods: Ethical approval was obtained from Queen Margaret College Ethics Committee. Following informed consent 12 healthy female subjects aged 18-26 years (mean 21) underwent threshold determinations of cold sensation (CS), warm sensation (WS), cold pain (CP) and heat pain (HP) at four different rates ofheating/ ooling (0.5, 1, 2.5 and 4°C/sec), the order of which was randomised. A Thermal Sensory Analyser (TSA-2001, Medoc Ltd.) was used with the thermode (30x30mm, adaptation temperature 32°C) ; applied to the thenar eminence of the dominant hand, using a I method of limits. Data were analysed using a one-way ANOVA with repeated measures.

Results: Measured threshold values for HP, WS and CP were significantly increased with faster rates of change (p<0.001). There was no significant effect of rate on CS values (p=0.653).

Conclusions: Results display a clear effect of rate on HP thresholds measured with this algorithm, as well as on WS and CP; these sensations all have a C-fibre mediated component (Verdugo & Ochoa, 1992). CS, an A6 mediated sensation, was unaffected. C fibres may be more subject to this phenomenon. In order to minimise the effects of reaction-time artefact, a low rate of change should be used. Acknowledgments: Supported by the Hospital Savings Association and the CSP Charitable Trust. Reference: Verdugo R & Ochoa JL (1992). Brain 115, 893-913.


Elisabeth Persson. Gunnel Ljunggren, Marcelo Rivano-Fischer, Dept. of Rehabilitation, Lunds Univ. Hospital, 221 85 Lund, Sweden.

Aim of Investigation: To evaluate changes in chronic pain patients in self-perception of occupation importance, performance and satisfaction using instrument aimed for occupation performance in areas of self-care, productivity and leisure (Canadian Occupational Performance Measurement, COPM) and to investigate relationship between these results and changes measured with validated tests of psychological well-being. Psychological General Well-being Index (PGWB) and psychosocial consequences of chronic pain, Multidimensional Pain Inventory (MPI).

Methods: COPM requires up to 5 occupations (activities) to be identified by patients. Their importance, performance and satisfaction are rated from 0-10 and a half-structured interview is conducted. Indexes are computed and differences due to treatment are expected to be positive. 60 consecutive patients are included. COPM is administered by an occupational therapist, PGWB and MPI by pain psychologist. COPM, PGWB and MPI are measured before and after the interdisciplinary pain management program.

Results: Significant improvements in both performance and satisfaction were made by most patients. Gender and ethnic background were found to be of significance in further analyses of improvements. Results from COPM and psychological measurement were found to correlate.

Conclusions: Our pilot study shows COPM to be sensible to changes in patients' self-perception of occupation performance and satisfaction. Activities targeted by patients to be measured by COPM can be considered to be rehabilitation goals that can be measured specifically by a standardised, validated instrument. A further study is conducted to test validity of follow-up COPM in mailed forms.


Lukas Radbruch. Peter Kiencke*, Gabriele Lindena, Rainer Saba-towski*, Georg Loick*, Dept ofAnaesthesiology and Dept of Medical Statistics, Informatics and Epidemiology, Univ of Cologne, 50924 Koln, Mundipharma GmbH, 65549 Limburg, Germany

Aim of Investigation: The Brief Pain Inventory (BPI) is available in many languages and has been used in different patient populations. However response characteristics for different settings have not been investigated up to now.

Methods: The BPI was used in different studies and different settings. Outpatients with chronic cancer- and non-cancer-related pain treated by general practitioners (n=3066) or in the pain clinic (n=151) and patients with chronic headache (n=141) were assessed as well as patients in the palliative care unit (n=92). Healthy students (n=78) were used as a control group. Sum scores were calculated for the 4 items on pain intensity (score 0-40) and the 7 items on interference with function (score 0-70). Pain relief was assessed on a 0-100% scale. Results:

Mean + SD Pain Intensity Pain Interference Pain relief
Students 5,8±3,3 8,5±11,4 29,0±41,2
General practitioners 22,6±6,7 46,3±13,1 40,8±22,3
Headache 15,4+9,6 27,7±18,7 41,0±34,1
Pain Clinic 21,0±9,6 34,6±16,8 45,5±28,3
Palliative Care Unit 16,3±7,1 42,0±17,6 67,6±26,4

Conclusions: The BPI is useful for patients with cancer pain and non-cancer pain and may be used even for patients with far advanced cancer disease. Pain relief was better with inpatient palliative care. Pain intensity sum scores were comparable in the general practitioner group and the pain clinic group, but interference sum scores were lower for the pain clinic patients.

9th WORLD CONGRESS ON PAIN, 1999, Vienna, Austria, p. 88 - 95


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