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Interdisciplinary rehabilitation of patients with chronic widespread pain: primary endpoint of the randomized, non-blinded, parallel-group IMPROvE trial
Amris K, Waehrens EE, Christensen R, Bliddal H, Danneskiold-Samsoe B, for the IMPROvE study group
Pain 2014 Jul;155(7):1356-1364
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

This study examined the functional and psychological outcomes of a two-week, group-based multi-component treatment course that targeted patients with chronic widespread pain. Patients (192, included in the intention-to-treat population), all fulfilling the 1990-ACR classification criteria for fibromyalgia, were consecutively recruited from a tertiary care setting and randomized (1:1) to either the treatment course or a waiting list control group. Co-Primary outcomes were the Assessment of Motor and Process Skills (AMPS) and SF36 Mental Composite Score (MCS) evaluated at 6-months follow-up. Primary endpoints were partly achieved with a statistically significant improvement in AMPS ADL motor (group mean difference 0.20 (95% CI 0.09 to 0.31) logits; p = 0.0003) and AMPS ADL process (0.20 (0.12 to 0.27) logits, p < 0.0001) ability measures, whereas no difference in the SF36-MCS (1.14 (95% CI -1.52 to 3.81), p = 0.40) was observed. Individual patient responses varied and the proportion of patients achieving a clinically meaningful change of at least 0.3 logits on the AMPS seemed influenced by the reporting of a pending social welfare application at the time of enrolment. We conclude that even in fibromyalgia patients presenting with a substantial disability established over many years, the two-week, multi-component treatment course resulted in observable improvement of functional ability in a subgroup of patients at 6-months follow-up. This improvement, however, was not reflected in secondary patient reported outcomes, including scores of self-reported functional ability on standardized questionnaires. It is suggested to include observation-based assessments in future clinical trials focusing on functional outcomes in patients with fibromyalgia.

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