Hammond 2006.
Methods | Randomised controlled trial | |
Participants | People diagnosed with fibromyalgia according to the ACR critiera were recruited through a hospital based rheumatology clinic Total participants = 183 randomised (133 completed) N = 120 female, N = 13 male Mean age = 48.53 (10.89) years Exclusions: alternative medical diagnosis could explain symptoms, undergoing current medical investigation, ongoing psychological problems requiring the care of a mental health practitioner or severe medical conditions affecting the person's ability to participate in exercise safely |
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Interventions | 1) Cognitive behavioural group based exercise and education intervention. 2 hour sessions, were held weekly for 10 weeks and included information on the physiological basis of symptoms, activity pacing, sleep hygiene, relaxation, problem solving, pain and stress management, cognitive restructuring, postural training, stretching exercises and tai chi. A tai chi DVD was provided to facilitate practice at home 2) Relaxation group based programme (which acted as an attention control), 1 hour sessions were held weekly for 10 weeks. Information on fibromyalgia and relaxation techniques were outlined with time allocated for group discussion |
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Outcomes | Measures relevant to this review: Fibromyalgia Impact Questionnaire, Arthritis Self‐efficacy Scale Assessment time points: baseline, 3 and 6 months |
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Notes | The study was funded by the Derbyshire Royal Infirmary Rheumatology Charitable Trust Fund (Derby Hospitals NHS Foundation Trust). The authors declare no conflicts of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A random component is included in the sequence generation process used |
Allocation concealment (selection bias) | Low risk | Computer generated random numbers in pre‐prepared sealed numbered envelopes |
Blinding of outcome assessment (detection bias) Questionnaire assessors blind? | Low risk | Self administered outcome measures used, assessor not believed to be able to bias findings |
Incomplete outcome data (attrition bias) All outcomes | Low risk | A 27% total attrition rate |
Selective reporting (reporting bias) | Low risk | All of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way |