Geraets 2005.
Methods | RCT; 2 arms; assessed at pre‐treatment, post‐treatment, 1 year | |
Participants | End of treatment n = 158 Start of treatment n = 176 Sex: 109 F, 83 M (at start of treatment) Mean age = 52.5 (SD 12.4) Source = mixed community and volunteer Diagnosis = shoulder pain Mean years of pain = not given |
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Interventions | "Graded exercise" "Primary care TAU" |
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Outcomes |
Primary pain outcome: NRS Primary disability outcome: Shoulder Disability Questionnaire Primary mood outcome: none Catastrophising outcomes: PCCL catastrophising Shoulder disability questionnaire Shoulder pain Pain intensity NRS Quality of life Fear avoidance Kinesiophobia (2 items) Pain Coping and Cognition List: catastrophising Pain Coping and Cognition List: coping General Practitioner visits Physician visits Physiotherapy visits Number of drug prescriptions Number of days work absence Total cost of health care (Euros) |
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Notes | BT versus TAU: analyses 7.1, 7.2, 7.4, 8.2 Yates quality scale: total quality = 26/35, design quality = 20/26, treatment quality = 6/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomisation according to random number table |
Allocation concealment (selection bias) | Low risk | Random number table generated by person not involved in study; opaque sealed envelopes; “Blinding for patients .... of allocated treatment was not possible” but treatment preferences elicited and shown to have no effect on outcome |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition fully reported; dropouts different in pain characteristics but not outcome measures at baseline |
Selective reporting (reporting bias) | Low risk | Fully reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researchers not involved in randomisation collect data |