NCT00066937.

Study characteristics
Methods	Design: parallel Duration: 8 weeks Assessment: baseline, post‐intervention, 3‐month follow‐up, 6‐month follow‐up Country: USA
Participants	Pain condition: temporomandibular joint disorders Population: adults aged 18‐65 with temporomandibular joint disorders Minimum pain intensity: no Inclusion criteria Age 18‐65 Pain ≤ 3 months duration due to temporomandibular joint disorder Exclusion criteria Severe physical and mental health co‐morbidities Total participants randomised: 140 Age in years (mean, SD): 37.2 (11.5) Gender: 28/140 were female Pain duration in years (mean, SD): NR
Interventions	Placebo (benztropine mesylate) + CBT n = 38 Active placebo + CBT Flexible titration: benztropine titrated up from 0.125 mg every night at bedtime to a maximum dose of 0.750 mg every night at bedtime based on treatment response and side effect profile 6 in‐person, individual sessions of CBT for pain management Nortriptyline + CBT n = 41 TCA + CBT Flexible titration: nortriptyline titrated up from 25 mg every night at bedtime to a maximum dose of 150 mg every night at bedtime based on treatment response and side effect profile 6 in‐person, individual sessions of CBT for pain management Placebo (benztropine mesylate) + management n = 24 Active placebo + management Flexible titration: benztropine titrated up from 0.125 mg every night at bedtime to a maximum dose of 0.750 mgevery night at bedtime based on treatment response and side effect profile 6 in‐person, individual sessions of temporomandibular joint disorder disease management Nortriptyline + management n = 37 TCA + management Flexible titration: nortriptyline titrated up from 25 mg every night at bedtime to a maximum dose of 150 mg every night at bedtime based on treatment response and side effect profile 6 in‐person, individual sessions of temporomandibular joint disorder disease management
Outcomes	Pain intensity Mood AEs SAEs Withdrawal
Missing data methods	Completer analysis
Funding source	Non‐pharmaceutical: Johns Hopkins University. Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
Conflicts of interest	NR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation methods not specified
Allocation concealment (selection bias)	Unclear risk	Allocation procedures not specified
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Although there are matched active placebos/interventions there is not enough information to determine blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Self‐reported outcomes from participants, but unsure of blinding procedures
Incomplete outcome data (attrition bias) All outcomes	High risk	Completer‐only analysis Attrition Total: 24/140 (17.1%) CBT: 5/38 (13.2%) Nortriptyline 25‐150 mg + CBT: 3/41 (7.3%) Disease management: 5/24 (20.8%) Nortriptyline 25‐150 mg + disease management: 11/37 (29.7%)
Selective reporting (reporting bias)	High risk	Changed primary outcome from physical and psychosocial function to "pain"
Other bias	High risk	Not published, all information and data extracted from trial registration: https://clinicaltrials.gov/ct2/show/study/NCT00066937