Leeuw 2008.
Methods | RCT; 2 arms; assessed at 2 pre‐treatment occasions, post‐treatment, 6‐month follow‐up, 12‐month follow‐up | |
Participants | End of treatment n = 77 Start of treatment n = 85 Sex: 41 F, 44 M Mean age = 45.3 (SD 9.5) Source = rehabilitation clinics, occupational health, pain department Diagnosis = back pain (and at least moderate fear on TSK) Mean years of pain = 9 |
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Interventions | "Exposure in vivo" "Operant graded activity" |
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Outcomes |
Primary pain outcome: MPQ pain intensity Primary disability outcome: Quebec Back Pain Disability Scale (Dutch version) Primary mood outcome: none Catastrophising outcome: PCS 1. Quebec Back Pain Disability Scale (Dutch version) 2. Patient Specific Complaints: VAS 0 to 100 of difficulty with 3 activities 3. Perceived harmfulness of activities (PHODA) 4. Pain Catastrophizing Scale: catastrophising 5. Daily activity: actimeter 6. Pain: mean of VAS 0 to 100 scales for current, worst and least pain |
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Notes | December 2009 search Exposure in vivo versus operant graded activity: analyses 5.1, 5.2, 5.4, 6.1, 6.2, 6.4 Yates quality scale: total quality = 32/35, design quality = 24/26, treatment quality = 8/9 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “predetermined and computer‐generated randomization schedule” |
Allocation concealment (selection bias) | Low risk | Sealed envelope; research assistant only could access randomization schedule |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Fully reported |
Selective reporting (reporting bias) | Low risk | Fully reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Electronic administration of assessments |