Skip to main content
. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

RBR‐5dsrhv.

Study characteristics
Methods Design: parallel
Duration: 16 weeks
Assessment: baseline and post‐intervention
Country: Brazil
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
  • Women between 18 and 59 with chronic temporomandibular pain

  • Intensity of muscle pain ≥ 7 on a 0‐10 VAS


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 96
Age in years (mean): 35.9
Gender: 96/96 were female
Pain duration in years (mean, SD): NR
Interventions Waitlist
  • n = 24

  • Participants kept on a waiting list for 4 months and instructed not to receive any other treatment for temporomandibular pain with telephone calls every 2 weeks


Amitriptyline 10 mg
  • n = 24

  • TCA

  • Fixed dose


Amitriptyline 10 mg + splint
  • n = 24

  • Combined intervention: TCA + splint

  • Amitriptyline = fixed dose

  • Use of an occlusal plaque stabiliser without occlusal guide during sleep


Acupuncture
  • n = 24

  • Weekly acupuncture performed by acupuncturist dental surgeons, totaling 16 sessions, with needling time of 20 min

Outcomes Pain intensity
Mood
Quality of life
Sleep
Withdrawal
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