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document
Multicomponent interdisciplinary group intervention for self-management of fibromyalgia : a mixed-methods randomized controlled trial . BACKGROUND This study evaluated the efficacy of the PASSAGE Program , a structured multicomponent interdisciplinary group intervention for the self-management of FMS . METHODS A mixed-methods randomized controlled trial ( intervention ( INT ) vs. waitlist ( WL ) ) was conducted with patients suffering from FMS . Data were collected at baseline ( T0 ) , at the end of the intervention ( T1 ) , and 3 months later ( T2 ) . The primary outcome was change in pain intensity ( 0-10 ) . Secondary outcomes were fibromyalgia severity , pain interference , sleep quality , pain coping strategies , depression , health-related quality of life , patient global impression of change ( PGIC ) , and perceived pain relief . Qualitative group interviews with a subset of patients were also conducted . Complete data from T0 to T2 were available for 43 patients . RESULTS The intervention had a statistically significant impact on the three PGIC measures . At the end of the PASSAGE Program , the percentages of patients who perceived overall improvement in their pain levels , functioning and quality of life were significantly higher in the INT Group ( 73 % , 55 % , 77 % respectively ) than in the WL Group ( 8 % , 12 % , 20 % ) . The same differences were observed 3 months post-intervention ( Intervention group : 62 % , 43 % , 38 % vs Waitlist Group : 13 % , 13 % , 9 % ) . The proportion of patients who reported ≥ 50 % pain relief was also significantly higher in the INT Group at the end of the intervention ( 36 % vs 12 % ) and 3 months post-intervention ( 33 % vs 4 % ) . Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention . The improvement , however , was not reflected in the primary outcome and other secondary outcome measures . CONCLUSION The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms . We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients ' experience . TRIAL REGISTRATION International Standard Randomized Controlled Trial Number Register ISRCTN14526380 .
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Intervention_Educational
PASSAGE Program
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Intervention_Educational
multicomponent interdisciplinary group intervention
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Intervention_Educational
( intervention ( INT ) vs.
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Intervention_Control
waitlist ( WL )
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Intervention_Educational
)
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Outcome_Pain
pain intensity
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Outcome_Adverse-effects
fibromyalgia severity
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Outcome_Pain
pain interference
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Outcome_Physical
sleep quality
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Outcome_Pain
pain coping strategies
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Outcome_Mental
depression
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Outcome_Other
health-related quality of life
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Outcome_Other
patient global impression of change ( PGIC )
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Outcome_Pain
perceived pain relief
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Outcome_Pain
pain levels
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Outcome_Other
functioning and quality of life
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Outcome_Pain
≥ 50 % pain relief
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Participant_Condition
fibromyalgia
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Participant_Condition
FMS
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Participant_Condition
patients suffering from FMS
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Participant_Sample-size
43 patients
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Participant_Condition
helping FMS patients
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Participant_Condition
on FMS