Active rehabilitation for chronic low back pain: Cognitive-behavioral, physical, or both? First direct post-treatment results from a randomized controlled trial [ISRCTN22714229]

BACKGROUND: The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model. There is evidence that rehabilitation of patients with chronic low back pain is more effective than no treatment, but information is lacking about the differential effectiveness of different kinds of rehabilitation. A direct comparison of a physical, a cognitive-behavioral treatment and a combination of both has never been carried out so far. METHODS: The effectiveness of active physical, cognitive-behavioral and combined treatment for chronic non-specific low back pain compared with a waiting list control group was determined by performing a randomized controlled trial in three rehabilitation centers. Two hundred and twenty three patients were randomized, using concealed block randomization to one of the following treatments, which they attended three times a week for 10 weeks: Active Physical Treatment (APT), Cognitive-Behavioral Treatment (CBT), Combined Treatment of APT and CBT (CT), or Waiting List (WL). The outcome variables were self-reported functional limitations, patient's main complaints, pain, mood, self-rated treatment effectiveness, treatment satisfaction and physical performance including walking, standing up, reaching forward, stair climbing and lifting. Assessments were carried out by blinded research assistants at baseline and immediately post-treatment. The data were analyzed using the intention-to-treat principle. RESULTS: For 212 patients, data were available for analysis. After treatment, significant reductions were observed in functional limitations, patient's main complaints and pain intensity for all three active treatments compared to the WL. Also, the self-rated treatment effectiveness and satisfaction appeared to be higher in the three active treatments. Several physical performance tasks improved in APT and CT but not in CBT. No clinically relevant differences were found between the CT and APT, or between CT and CBT. CONCLUSION: All three active treatments were effective in comparison to no treatment, but no clinically relevant differences between the combined and the single component treatments were found

The differential role of pain, work characteristics and pain-related fear in explaining back pain and sick leave in occupational settings

Abstract This cross-sectional questionnaire study investigated the role of pain (pain severity, radiating pain), work characteristics (physical workload, job stressors, job satisfaction), negative affect and pain-related fear in accounting for low back pain (LBP) and sick leave (SL) in 1294 employees from 10 companies in Belgium and the Netherlands. An increased risk for short-term LBP (1-30 days during the last year) was observed for workers reporting high physical workload (ORZ2.39), high task exertion (ORZ1.63) and high negative affect (ORZ1.03). For prolonged LBP (O30 days during the last year) severe pain (ORZ13.03), radiating pain (ORZ2.37) and fear of work-related activities (ORZ3.17) were significant risk factors. A lack of decision latitude decreased the risk of long-term LBP (ORZ0.39). Short-term SL (1-30 days during the last year) was associated with severe pain (ORZ2.83), high physical workload (ORZ2.99) and high fear of movement/(re)injury (ORZ1.88). A lack of decision latitude increased the risk of short-term SL (ORZ1.92). Long-term SL (O30 days during the last year) was associated with radiating pain (ORZ3.80) and high fear of movement/(re)injury (ORZ6.35). A lack of co-worker support reduced the risk of long-term SL (ORZ0.27). These results suggest that physical load factors are relatively more important in the process leading to short-term LBP and short-term SL, whereas job stressors, severe pain, radiation, and pain-related fear are more important in determining the further course and maintenance of the inability to work. The potential implications of these findings for primary and secondary prevention, and occupational rehabilitation are discussed.

Pain and pain-related fear are associated with functional and social disability in an occupational setting: Evidence of mediation by pain-related fear

This study examined the role of work-related, psychosocial and psychological factors in predicting functional and social disability in working employees. In a cross-sectional design, 890 working employees (reporting at least 1 day of back pain during the past year) completed self-report measures of back pain, disability, pain-related fear, negative and positive affectivity, job satisfaction, job stress and physical work load. Regression analyses revealed that pain intensity was a strong predictor of functional (beta =.69, p <.001) and social disability (beta =.67, p <.001). Fear of (re)injury due to movement (beta =.25, p <.001; beta =.28, p <.001) had additional predictive value in both models. Further, (singular) mediation tests indicated that fear for (re)injury partially mediated the relation between pain intensity and disability, and between negative affectivity and disability. Finally, path analyses revealed both fear and pain intensity as mediators between negative affectivity and disability. Overall, our findings point at the relevance of the cognitive-behavioral model of avoidance in occupational settings. (C) 2005 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. All rights reserved.status: publishe

Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial

To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to standard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis (AS) patients. A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 was treated in a spa resort in Bad Hofgastein, Austria; group 2 in a spa resort in Arcen, The Netherlands. The control group stayed at home and continued their usual activities and standard treatment during the intervention weeks. After the intervention, all patients followed weekly group physical therapy. The total study period was 40 weeks. Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index (BASFI). Utilities were measured with the EuroQoL (EQ-5D(utility)). A time-integrated summary score defined the clinical effects (BASFI-area under the curve [AUC]) and utilities (EQ-5D(utility)-AUC) over time. Both direct (health care and non-health care) and indirect costs were included. Resource utilization and absence from work were registered weekly by the patients in a diary. All costs were calculated from a societal perspective. A total of 111 patients completed the diary. The between-group difference for the BASFI-AUC was 1.0 (95% confidence interval [95% CI] 0.4-1.6; P = 0.001) for group 1 versus controls, and 0.6 (95% CI 0.1-1.1; P = 0.020) for group 2 versus controls. The between-group difference for EQ-5D(utility)-AUC was 0.17 (95% CI 0.09-0.25; P <0.001) for group 1 versus controls, and 0.08 (95% CI 0.00-0.15; P = 0.04) for group 2 versus controls. The mean total costs per patient (including costs for spa therapy) in Euros (euro;) during the study period were euro;3,023 for group 1, euro;3,240 for group 2, and euro;1,754 for the control group. The incremental cost-effectiveness ratio per unit effect gained in functional ability (0-10 scale) was euro;1,269 (95% CI 497-3,316) for group 1, and euro;2,477 (95% CI 601-12,098) for group 2. The costs per quality-adjusted life year gained were euro;7,465 (95% CI 3,294-14,686) for group 1, and euro;18,575 (95% CI 3,678-114,257) for group 2. Combined spa-exercise therapy besides standard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with standard treatment alone in patients with A

A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

Department of Internal Medicine, University Hospital Maastricht, The Netherlands. [email protected] OBJECTIVE: To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). METHODS: One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n = 58), biofeedback training (n = 56), or controls (n = 29). Half the patients in the active treatment groups also received an educational program aimed at improving compliance. Assessments were done at baseline and after 24 weeks. The primary outcome was pain [visual analog scale (VAS)]. Other endpoints were the number of tender points, total myalgic score (dolorimetry), physical fitness, functional ability (Arthritis Impact Measurement Scale and Sickness Impact Profile), psychological distress (Symptom Checklist-90-Revised), patient global assessment (5 point scale), and general fatigue (VAS). RESULTS: Baseline scores were similar in all 3 groups. Altogether 25 (17.5%) patients dropped out; they were similarly distributed over all groups: 14 patients after randomization and 11 (8%) during the study. A true high impact level for fitness training was not attained by any patient. After treatment, no significant differences in change scores of any outcome were found between the groups (ANOVA, p > 0.05). All outcome measures showed large variations intra- and interindividually. The educational program did not result in higher compliance with training sessions (62% vs 71%). Analysis of the subgroup of subjects with a high attendance rate (> 67%) also showed no improvement. CONCLUSION: In terms of training intensity and maximal heart rates, the high impact fitness intervention had a low impact benefit. Therefore effectiveness of high impact physical fitness training cannot be demonstrated. Thus compared to usual care, the fitness training (i.e., low impact) and biofeedback training had no clear beneficial effects on objective or subjective patient outcomes in patients with FM. Publication Types: Clinical Trial Randomized Controlled Tria

High or low intensity aerobic fitness training in fibromyalgia: does it matter?

Department of Internal Medicine, University Hospital, Maastricht, The Netherlands. [email protected] OBJECTIVE: To determine the efficacy of training in fibromyalgia (FM), we compared the effects of high intensity fitness training (HIF) and low intensity fitness training (LIF). METHODS: Thirty-seven female patients with FM were randomly allocated to either a HIF group (n = 19) or a LIF group (n = 18). Four patients (1 HIF group, 3 LIF group) refused to participate after randomization but before the start of the intervention. They were excluded from the analysis. Assessments were performed at baseline and after 20 weeks of HIF or LIF. The primary outcome was patient's global assessment [on 100 mm visual analog scale (VAS)]. Secondary endpoints were pain, number of tender points, total myalgic score, physical fitness, health status, and psychological distress. RESULTS: One patient in the HIF group (n = 18) and 2 in the LIF group (n = 15) stopped training sessions during the course of the study. Nine of 18 patients in the HIF group compared to 8 of 15 patients in the LIF group achieved a participation rate of 67% or more. Most important reasons for nonadherence were postexercise pain and fatigue, time consumption, and stress. The VAS for global well being improved slightly from 64 to 56 mm in the HIF group, and did not change in the LIF group (58 to 61 mm) (p = 0.07). The Wmax (physical fitness) changed modestly from 110 to 123 watt in the HIF group, and from 97 to 103 watt in the LIF group (p = 0.3). VAS for pain increased from 53 to 64 mm in the HIF group and from 52 to 54 mm in the LIF group. The large standard deviations around mean change in global assessments, number of tender points, total myalgic score, and psychological distress (by SCL-90) severely influenced the power to detect within- and between-group differences. Analysis limited to those patients who accomplished a high attendance rate (> 67%) showed similar results. CONCLUSION: High intensity physical fitness training compared to low intensity physical fitness training leads to only modest improvements in physical fitness and general well being in patients with FM, and does not positively affect psychological status and general health. Publication Types: Clinical Trial Randomized Controlled Tria