RBR‐5dsrhv.
Study characteristics | ||
Methods | Design: parallel Duration: 16 weeks Assessment: baseline and post‐intervention Country: Brazil |
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Participants | Pain condition: temporomandibular pain Population: women aged 18‐59 with chronic temporomandibular pain Minimum pain intensity: intensity of muscle pain ≥ 7 on a 0‐10 VAS Inclusion criteria
Exclusion criteria
Total participants randomised: 96 Age in years (mean): 35.9 Gender: 96/96 were female Pain duration in years (mean, SD): NR |
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Interventions | Waitlist
Amitriptyline 10 mg
Amitriptyline 10 mg + splint
Acupuncture
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Outcomes | Pain intensity Mood Quality of life Sleep Withdrawal |
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Missing data methods | Completer‐only analysis | |
Funding source | Non‐pharmaceutical: thanks the CAPES scholarship for fund | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised by means of random numbers generated by computer |
Allocation concealment (selection bias) | Low risk | The randomisation of patients in the 4 groups was carried out by means of opaque and sealed envelopes encoded by 'A', 'B', 'C' or 'D', prepared by a researcher without contact with the other procedures. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind the participants and the clinicians due to the nature of the interventions. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes from unblinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only. Unequal attrition ‐ many more participants withdrew from the acupuncture group than the other groups. Attrition Total: 18/96 (18.75%) Waitlist: 3/24 (12.5%) Amitriptyline 10 mg: 3/24 (12.5%) Amitriptyline 10 mg + splint: 1/24 (4.2%) Acupuncture: 11/24 (45.8%) |
Selective reporting (reporting bias) | Unclear risk | Trial was registered on the Brazilian Registry of Clinical Trials after completion. |
Other bias | Unclear risk | Extracted from a doctoral thesis translated from Portuguese ‐ can't find published papers |