Pain Exposure Physical Therapy versus conventional treatment in complex regional pain syndrome type 1-a cost-effectiveness analysis alongside a randomized controlled trial.

OBJECTIVE: To analyze cost-effectiveness of Pain Exposure Physical Therapy compared to conventional treatment alongside a randomized controlled trial (NCT00817128) in patients with complex regional pain syndrome type 1, where no clinical difference was shown between the two groups in an intention-to-treat analysis. DESIGN: Randomized controlled trial with 9 months follow-up. SETTING: Patients were recruited from hospitals and general practitioners in the region around a university hospital. SUBJECTS: A total of 56 patients, 45 (80.4%) female, were randomized. About 4 patients in the intervention and 11 patients in the conventional group switched groups. The mean (SD) age was 44.3 (16.6) years, and in 37 (66.1%) patients, the upper extremity was affected. INTERVENTIONS: Patients received either Pain Exposure Physical Therapy (maximum of five sessions), or conventional treatment conforming with the Dutch multidisciplinary guideline. MAIN MEASURES: For the economic evaluation difference between the groups in health-related quality of life (quality-adjusted life years (QALYs)), and the clinical outcomes Impairment level Sum Score-Restricted Version and Pain Disability was determined based on the intention-to-treat analysis as well as differences in both healthcare-related costs and travel expenses. Cost-effectiveness planes were constructed using bootstrapping to compare effects and costs. RESULTS: No significant effects were found for QALYs (mean difference = -0.02; 95% confidence interval (CI) -0.10 to 0.04) and clinical outcomes. A cost minimization analysis showed a significant difference in costs between groups. The conventional treatment was 64% more expensive than the Pain Exposure Physical Therapy. CONCLUSION: This economic analysis shows that Pain Exposure Physical Therapy compared to conventional treatment is cost-effective.

The effectiveness and cost evaluation of pain exposure physical therapy and conventional therapy in patients with complex regional pain syndrome type 1. Rationale and design of a randomized controlled trial.

BACKGROUND: Pain Exposure Physical Therapy is a new treatment option for patients with Complex Regional Pain Syndrome type 1. It has been evaluated in retrospective as well as in prospective studies and proven to be safe and possibly effective. This indicates that Pain Exposure Physical Therapy is now ready for clinical evaluation. The results of an earlier performed pilot study with an n = 1 design, in which 20 patients with Complex Regional Pain Syndrome type 1 were treated with Pain Exposure Physical Therapy, were used for the design and power calculation of the present study.After completion and evaluation of this phase III study, a multi-centre implementation study will be conducted.The aim of this study is to determine whether Pain Exposure Physical Therapy can improve functional outcomes in patients with Complex Regional Pain Syndrome type 1. METHODS/DESIGN: This study is designed as a single-blinded, randomized clinical trial. 62 patients will be randomized with a follow-up of 9 months to demonstrate the expected treatment effect. Complex Regional Pain Syndrome type 1 is diagnosed in accordance with the Bruehl/International Association for the Study of Pain criteria. Conventional therapy in accordance with the Dutch guideline will be compared with Pain Exposure Physical Therapy. Primary outcome measure is the Impairment level SumScore, restricted version. DISCUSSION: This is the first randomized controlled study with single blinding that has ever been planned in patients with Complex Regional Pain Syndrome type 1 and does not focus on a single aspect of the pain syndrome but compares treatment strategies based on completely different pathophysiological and cognitive theories.

Cost effectiveness and cost utility of acetylcysteine versus dimethyl sulfoxide for reflex sympathetic dystrophy.

OBJECTIVE: To determine the cost effectiveness and cost utility of acetylcysteine versus dimethyl sulfoxide (DMSO) for patients with reflex sympathetic dystrophy (RSD), from a societal viewpoint. DESIGN: An economic evaluation was conducted alongside a double-dummy, double-blind, randomised, controlled trial. Patients were followed for 1 year. The primary outcome measure was the Impairment-level Sum Score (ISS). Utilities were determined by the EuroQOL instrument (EQ-5D). Both cost-effectiveness and cost-utility analyses were performed. Differences in mean direct, indirect and total costs were estimated. Corresponding 95% confidence intervals were calculated by bootstrapping techniques. RESULTS: Both groups (DMSO, n = 64; acetylcysteine, n = 67) showed relevant improvement; no differences in effects were found. Only the total direct costs were significantly lower in the DMSO group for the period of 0-52 weeks. The incremental cost-effectiveness ratios showed that, in general, DMSO generated fewer costs and more effects compared with acetylcysteine. Post-hoc subgroup analyses on cost effectiveness suggested that patients with warm RSD could be best treated with DMSO and patients with cold RSD with acetylcysteine. These results were based on small subsamples. CONCLUSION: In general, DMSO is the preferred treatment for patients with RSD.

Economic evaluation of spinal cord stimulation for chronic reflex sympathetic dystrophy.

OBJECTIVE: To evaluate the economic aspects of treatment of chronic reflex sympathetic dystrophy (RSD) with spinal cord stimulation (SCS), using outcomes and costs of care before and after the start of treatment. METHODS: Fifty-four patients with chronic RSD were randomized to receive either SCS together with physical therapy (SCS+PT; n = 36) or physical therapy alone (PT; n = 18). Twenty-four SCS+PT patients responded positively to trial stimulation and underwent SCS implantation. During 12 months of follow-up, costs (routine RSD costs, SCS costs, out-of-pocket costs) and effects (pain relief by visual analogue scale, health-related quality of life [HRQL] improvement by EQ-5D) were assessed in both groups. Analyses were carried out up to 1 year and up to the expected time of death. RESULTS: SCS was both more effective and less costly than the standard treatment protocol. As a result of high initial costs of SCS, in the first year, the treatment per patient is $4,000 more than control therapy. However, in the lifetime analysis, SCS per patient is $60,000 cheaper than control therapy. In addition, at 12 months, SCS resulted in pain relief (SCS+PT [-2.7] vs PT [0.4] [p < 0.001]) and improved HRQL (SCS+PT [0.22] vs PT [0.03] [p = 0.004]). CONCLUSIONS: The authors found SCS to be both more effective and less expensive as compared with the standard treatment protocol for chronic RSD.

Cost-effectiveness analysis of adjuvant physical or occupational therapy for patients with reflex sympathetic dystrophy.

OBJECTIVE: To study from a societal viewpoint the cost-effectiveness of adjuvant treatment for patients with reflex sympathetic dystrophy (RSD) of one upper extremity. DESIGN: A two-center randomized clinical trial comparing pairwise physical therapy (PT), occupational therapy (OT), and control treatment (CT). PATIENTS: One hundred thirty-five patients with RSD for less than 1 year participated. INTERVENTIONS: PT and OT were given according to protocols. For CT, services by social workers were offered. MAIN OUTCOME MEASURES: The Impairment-level Sum Score (ISS), the modified Greentest, and the Sickness Impact Profile (SIP) were used to determine effectiveness. Real medical costs, nonmedical costs, and productivity costs were distinguished and incremental cost-effectiveness ratios were calculated. Sensitivity analyses were performed on cost estimates. RESULTS: The ISS, but not the Greentest and SIP, showed a significant difference between PT versus OT and CT. The mean adjuvant treatment costs were significantly higher for PT (Netherlands Guilders [NLG] 1,726) and OT (NLG 2,089) compared with CT (NLG 903). The mean total medical costs were not significantly different for the groups (PT, NLG 8,692; OT, NLG 13,023; and CT, NLG 7,888) (intention-to-treat analysis). The sensitivity analyses showed a moderate influence of the cost estimates. CONCLUSIONS: PT results in clinically relevant improvement in RSD. Costs associated with adjuvant treatment are moderate compared to other medical costs. The incremental cost-effectiveness ratios of PT versus OT and CT were moderate or even dominant, thus PT was both more effective and less costly than its comparators.