Wynand Francois Louw1, K Dean Reeves2, Stanley K H Lam3, An-Lin Cheng4, David Rabago5. 1. Department of Family Practice, University of British Columbia, Vancouver, Canada. 2. Private Practice, Physical Medicine and Rehabilitation, Roeland Park, KS. Electronic address: DeanReevesMD@gmail.com. 3. Department of Family Medicine, Chinese University of Hong Kong, Hong Kong. 4. Department of Biomedical and Health Informatics, University of Missouri-Kansas City, School of Medicine, Kansas City, MO. 5. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI.
Abstract
OBJECTIVE: To assess the efficacy and longer-term effectiveness of dextrose prolotherapy injections in participants with temporomandibular dysfunction. PATIENTS AND METHODS: A randomized controlled trial with masked allocation was conducted from January 14, 2013, through December 19, 2015. Forty-two participants (with 54 joints) meeting temporomandibular dysfunction criteria were randomized (1:1) to 3 monthly intra-articular injections (20% dextrose/0.2% lidocaine or 0.2% lidocaine) followed by as-needed dextrose/0.2% lidocaine injections through 1 year. Primary and secondary outcome measures included a 0 to 10 Numerical Rating Scale score for facial pain and jaw dysfunction; maximal interincisal opening (MIO) measured in millimeters, percentage of joints with 50% or more change (improvement) in pain and function, and satisfaction. RESULTS: Randomization produced a control group with more female participants (P=.03), longer pain duration (P=.01), and less MIO (P=.01). Upon 3-month analysis, including pertinent covariates, dextrose group participants reported decreased jaw pain (4.3±2.9 points vs 1.8±2.7 points; P=.02), jaw dysfunction (3.5±2.8 points vs 1.0±2.1 points; P=.008), and improved MIO (1.5±4.1 mm vs -1.8±5.1 mm; P=.006). Control group participants received dextrose injections beginning at 3 months. No between-group differences were noted at 12 months; pooled data suggested that jaw pain, jaw function, and MIO improved by 5.2±2.7 points (68%), 4.1±2.8 points (64%), and 2.1±5.5 mm, respectively. Pain and dysfunction improved by at least 50% in 38 of 54 (70%) and 39 of 54 (72%) jaws, respectively. CONCLUSION:Intra-articular dextrose injection (prolotherapy) resulted in substantial improvement in jaw pain, function, and MIO compared with masked control injection at 3 months; clinical improvements endured to 12 months. Satisfaction was high. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01706172.
RCT Entities:
OBJECTIVE: To assess the efficacy and longer-term effectiveness of dextrose prolotherapy injections in participants with temporomandibular dysfunction. PATIENTS AND METHODS: A randomized controlled trial with masked allocation was conducted from January 14, 2013, through December 19, 2015. Forty-two participants (with 54 joints) meeting temporomandibular dysfunction criteria were randomized (1:1) to 3 monthly intra-articular injections (20% dextrose/0.2% lidocaine or 0.2% lidocaine) followed by as-needed dextrose/0.2% lidocaine injections through 1 year. Primary and secondary outcome measures included a 0 to 10 Numerical Rating Scale score for facial pain and jaw dysfunction; maximal interincisal opening (MIO) measured in millimeters, percentage of joints with 50% or more change (improvement) in pain and function, and satisfaction. RESULTS: Randomization produced a control group with more female participants (P=.03), longer pain duration (P=.01), and less MIO (P=.01). Upon 3-month analysis, including pertinent covariates, dextrose group participants reported decreased jaw pain (4.3±2.9 points vs 1.8±2.7 points; P=.02), jaw dysfunction (3.5±2.8 points vs 1.0±2.1 points; P=.008), and improved MIO (1.5±4.1 mm vs -1.8±5.1 mm; P=.006). Control group participants received dextrose injections beginning at 3 months. No between-group differences were noted at 12 months; pooled data suggested that jaw pain, jaw function, and MIO improved by 5.2±2.7 points (68%), 4.1±2.8 points (64%), and 2.1±5.5 mm, respectively. Pain and dysfunction improved by at least 50% in 38 of 54 (70%) and 39 of 54 (72%) jaws, respectively. CONCLUSION:Intra-articulardextrose injection (prolotherapy) resulted in substantial improvement in jaw pain, function, and MIO compared with masked control injection at 3 months; clinical improvements endured to 12 months. Satisfaction was high. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01706172.