Goldman 2010.
Study characteristics | ||
Methods | Design: parallel Duration: 6 weeks Assessment: baseline and post‐intervention Country: USA |
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Participants | Pain condition: arm pain Population: people with persistent arm pain from repetitive use Minimum pain intensity: ≥ 3 on 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 118 Age in years (mean): 37.5 Gender: 66/118 were female Pain duration in years (mean, SD): NR |
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Interventions | Placebo
Amitriptyline 25 mg
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Outcomes | Pain intensity Sleep Mood AEs SAEs Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | Non‐pharmaceutical: "This study was supported by Grants 1RO1 AT 00402‐01 and 1K24 AT 004095 from the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health, USA" | |
Conflicts of interest | "No author had or now has any financial interest in any for‐profit organisation related to the treatment of patients with repetitive strain injuries or related disabling conditions. Dr Rose Goldman sometimes serves as a paid expert witness, independent medical examiner, and/or consultant in workers' compensation and disability cases that might involve musculoskeletal problems and repetitive strain injuries." | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a permuted block randomisation design |
Allocation concealment (selection bias) | Low risk | Participants were allocated using assignments sealed in sequentially numbered opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, identical study drugs and matched dosing |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT with LOCF but low attrition Attrition Total: 12/118 (10.2%) Placebo: 4/59 (6.8%) Amitriptyline 25 mg: 8/59 (13.6%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |