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.

The adaptation of a Danish version of the Pain Self‐Efficacy Questionnaire: reliability and construct validity in a population of patients with fibromyalgia in Denmark

“…Indications of DIF were found on several items of the PSEQ‐DK. This could for the most part be rationally explained, except for the higher TP count, (a measure of disease severity) , being associated with higher scores on item 3 (socialising with friends and family). However, the observed DIF might not be of too much concern in regard to scale properties, as suggested by the high correlation between a shortened scale without DIF and the full scale.…”

“…The generalisability of the results is limited because the study included a selected group of patients. Although the participants were able to complete the group‐based multidisciplinary rehabilitation programme in the clinic, the sample did include a large proportion of the most affected patients with fibromyalgia . It is possible that a less selected population could have yielded a different result.…”

“…Patients referred to the rehabilitation programme are generally characterised by substantial chronicity. The typical patient averages 10 years with pain and demonstrates substantial limitations in activity and societal level functioning . Based on a recommendation of 5–10 test subjects per item , a sample of 100 patients was estimated to be sufficient to perform the psychometric analyses.…”

“…Strong self‐efficacy may predict actual performance, positively influence functional ability and represent a significant mediator between pain and functioning . Fibromyalgia is characterised by chronic widespread pain and a range of secondary features, including nonrestorative sleep, fatigue, cognitive dysfunction and emotional distress , which may lead to significant pain‐related disability, affecting activities of daily living (ADL) and health‐related quality of life . Rehabilitative intervention strategies focusing on continuous self‐management and maintenance of optimal functioning are therefore recommended in the management of fibromyalgia .…”

Observational Study of a Wearable Sensor and Smartphone Application Supporting Unsupervised Exercises to Assess Pain and Stiffness

“…Many modern clinical studies on pain and stiffness rely on tests performed in the clinic [26][27][28][29], which are necessarily infrequent, as many tests are invasive and require expensive clinic times. Moreover, in the case of morning stiffness, the clinic assessment cannot be A high correlation between 5×STS test duration and pain severity was demonstrated.…”