Cherkin 1996.
| Methods | RCT | |
| Participants | N=294; Mean age: 42.6; Gender (female): 48%; Diagnosis: LBP (sciatica included) or hip pain. Setting: Primary Care. | |
| Interventions | (E1) A booklet with biopsycho‐social information plus usual care (N= 102); (E2) Nurse intervention: a booklet with biopsychosocial information, a 15‐min session with a clinic nurse, a follow‐up phone call plus usual care (N=95); (C) Usual care (N=97). | |
| Outcomes | Back pain‐specific functional status:
Roland Disability score (0 to 24, 0 = no disability) overall at baseline and change at 1 wk: (E1) 13.8, ‐5.4; (E2) 13.8, ‐5.2; (C) 13.8, ‐5.3
% Patients with any bed days in first 7 wks and in 6th to 12th mo: (E1) 23%, 8%; (E2) 28%, 6%; (C) 21%, 7% Global improvement: Bothersomeness (0 to 10), overall at baseline and change at 1 wk: (E1) 7.4, ‐3.3; (E2) 7.4, ‐3.5; (C) 7.4 ‐3.6 Return to work: % Patients with any work‐loss days in first 7 wks and in 6th to 12th mo: (E1) 24%, 7%; (E2) 36%, 6% ; (C) 29%, 9% Secondary outcomes: 'Perceived knowledge': at 1 wk, (E1) and (E2) superior to (C); at 3 and 7 wk, (E2) superior to (E1) and (C) (P<0.05) 'Satisfaction with care': at 1 wk, (E2) superior to (E1) and (C) (P<0.05) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | |
| Allocation concealment? | Unclear risk | B ‐ Unclear |
| Blinding? All outcomes ‐ patients? | High risk | |
| Blinding? All outcomes ‐ providers? | High risk | |
| Blinding? All outcomes ‐ outcome assessors? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs during intervention? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ drop‐outs during follow‐up? | Low risk | |
| Incomplete outcome data addressed? All outcomes ‐ ITT analysis? | Low risk | |
| Similarity at baseline characteristics? | Low risk | |
| Co‐interventions avoided or similar? | Low risk | |
| Compliance acceptable? | Low risk | |