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. 2022 Aug 11;2022(8):CD013515. doi: 10.1002/14651858.CD013515.pub2

Gatchel 2006.

Study characteristics
Methods Study design: parallel‐group RCT
Number of control groups: 1
Number of intervention groups: 1
Participants Inclusion criteria: adults age 18 to 70 years, jaw or facial pain present for less than 6 months
Exclusion criteria: comorbid pain‐exacerbating physical condition (such as cancer or fibromyalgia), history of jaw pain before the most recent episode
Pretreatment: no significant demographic differences at baseline.
Number eligible for study: 101
Number of participants: 101
Number randomly assigned to intervention (control): 56 (45)
Number started treatment in intervention (control): 56 (45)
Number completed treatment in intervention (control): 54 (45)
Number included in analysis from intervention (control): 54 (45)
Comorbidity: major comorbidities excluded
Sex: female 80.5%, male 19.5%
Ethnicity: white 78.5%, Hispanic 12%, African American 8%, Asian 4.5%, other 3%
Other sample characteristics: marital status, employment status, health/dental insurance, education, income, referrer
Interventions
  • CBT/biofeedback

  • Usual care

Outcomes
  • CPI

  • BDI


Used in study but not review:
  • Ways of Coping Questionnaire

  • West Haven‐Yale MPI

  • Schedule for Nonadaptive and Adaptive Personality

  • Structured Clinical Interview based on DSM

  • Physical examination based on RDC 

  • Chewing performance evaluation

Identification Date of study: paper published 2006
Sponsorship source: supported in part by National Institutes of Health grants 2R01 DE10713, 2R01 MH46452 and 1K05 MH071892
Setting: specialist TMD clinic, TMD clinical research programme
Country: USA
Author name: Robert J Gatchel
Institution: University of Texas at Arlington
Email: gatchel@uta.edu
Address: Department of Psychology, College of Science, University of Texas at Arlington, 313 Life ScienceBuilding, 501 S. Nedderman Drive, Arlington, Texas 76019‐0528
Notes Early intervention group participants were more likely to also seek additional treatment from a range of other practitioners during the study period, which could account for some differences in outcome.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Details of randomisation method not given
Allocation concealment (selection bias) High risk Details not given
Blinding of participants and personnel (performance bias)
All outcomes High risk Not possible to blind participants to this kind of treatment. Blinding of study personnel not mentioned
Blinding of outcome assessment (detection bias)
All outcomes High risk Blinding of outcome assessors not discussed
Incomplete outcome data (attrition bias)
All outcomes Low risk 98 of 101 participants completed 1‐year follow‐up
Selective reporting (reporting bias) Low risk Clearly defined outcome measures with good rationale described and thoroughly reported
Other bias Unclear risk Note although mean duration of TMD is 97 days, it was not possible to separate participants who had experienced symptoms for less than 3 months. Participants in the treatment group were more likely to also seek other forms of treatment, which could influence outcome