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Interdisciplinary rehabilitation of patients with chronic widespread pain: primary endpoint of the randomized, nonblinded, parallel-group IMPROvE trial

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@article{98bc4d86e9104cbbb1ff0c6f26fac7c0,
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.",
author = "Kirstine Amris and W{\ae}hrens, {Eva E} and Robin Christensen and Henning Bliddal and Bente Danneskiold-Sams{\o}e and {IMPROvE Study Group}",
note = "Copyright {\circledC} 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.",
year = "2014",
month = "7",
doi = "10.1016/j.pain.2014.04.012",
language = "English",
volume = "155",
pages = "1356--64",
journal = "Pain",
issn = "0304-3959",
publisher = "Elsevier BV",
number = "7",

}

RIS

TY - JOUR

T1 - Interdisciplinary rehabilitation of patients with chronic widespread pain

T2 - primary endpoint of the randomized, nonblinded, parallel-group IMPROvE trial

AU - Amris, Kirstine

AU - Wæhrens, Eva E

AU - Christensen, Robin

AU - Bliddal, Henning

AU - Danneskiold-Samsøe, Bente

AU - IMPROvE Study Group

N1 - Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

PY - 2014/7

Y1 - 2014/7

N2 - 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.

AB - 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.

U2 - 10.1016/j.pain.2014.04.012

DO - 10.1016/j.pain.2014.04.012

M3 - Journal article

VL - 155

SP - 1356

EP - 1364

JO - Pain

JF - Pain

SN - 0304-3959

IS - 7

ER -

ID: 44650054