title: Interdisciplinary rehabilitation of patients with chronic widespread pain: primary endpoint of the randomized, nonblinded, parallel-group IMPROvE trial.
abstract: This study examined the functional and psychological outcomes of a 2-week, group-based multicomponent treatment course that targeted patients with chronic widespread pain. Patients (192 included in the intention-to-treat population), all fulfilling the 1990 American College of Rheumatology 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 SF-36 Mental Composite Score (MCS) evaluated at 6-month follow-up. Primary endpoints were partly achieved with a statistically significant improvement in AMPS activities of daily living motor (group mean difference: 0.20 [95% confidence interval (CI): 0.09 to 0.31] logits; P=.0003) and AMPS activities of daily living process (0.20 [95% CI: 0.12 to 0.27] logits, P<.0001) ability measures, whereas no difference in the SF-36 MCS (1.14 [95% CI: -1.52 to 3.81], P=.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 enrollment. We conclude that even in fibromyalgia patients presenting with a substantial disability established over many years, the 2-week multicomponent treatment course resulted in observable improvement of functional ability in a subgroup of patients at 6-month follow-up. This improvement, however, was not reflected in secondary patient reported outcomes, including scores of self-reported functional ability on standardized questionnaires. We suggest including observation-based assessments in future clinical trials focusing on functional outcomes in patients with fibromyalgia.
authors.affiliation: The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark Institute of Public Health, University of Southern Denmark, Odense, Denmark Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.
authors.forename: Kirstine
authors.initials: K
authors.lastname: Amris
authors.forename: Eva E
authors.initials: EE
authors.lastname: Wæhrens
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.forename: Henning
authors.initials: H
authors.lastname: Bliddal
authors.forename: Bente
authors.initials: B
authors.lastname: Danneskiold-Samsøe
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D059350:Chronic Pain / Q000534:rehabilitation*; D005260:Female; D005356:Fibromyalgia / Q000628:therapy*; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D009788:Occupational Therapy / Q000379:methods*; D026741:Physical Therapy Modalities; D011613:Psychotherapy / Q000379:methods*; D011615:Psychotherapy, Group / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome
keywords: AMPS; Chronic widespread pain; Fibromyalgia; Functional ability; Multicomponent therapy; Randomized controlled trial
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