Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jul 9, 2020
Date Accepted: Aug 18, 2020
An Internet-Based Multimodal Pain Program with Telephone Support for Adults with Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial
ABSTRACT
Background:
Chronic pain from temporomandibular disorders (TMD) remains an undertreated condition with controversies regarding the most effective treatment modalities. National guidelines in Sweden recommend multimodal treatment with a behavioral approach, and internet-based intervention is an appealing treatment modality as it enables more patients to be reached.
Objective:
To investigate the treatment effect of an internet-based multimodal pain program (iMPP) on chronic TMD pain and evaluate the feasibility of running a larger, randomized controlled trial (RCT).
Methods:
An unblinded, randomized controlled pilot trial was conducted. Forty-three participants (34 females, 9 males, median [25/75th percentile] age 27 [23/37] years) with chronic TMD pain, recruited within the Public Dental Health Service, were randomized to intervention (n=20) or active control (n=23). The intervention comprised of a dentist-assisted iMPP with seven modules based on cognitive-behavioral therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at three and six months after treatment start. Evaluation of the feasibility of the study concerned testing the study protocol and also included an estimation of recruitment and attrition rates in the current research setting.
Results:
Only 49% of participants provided data at the 6-month follow-up (21/43; n=7 in iMPP group, n=14 in controls). Of the 20 randomized to iMPP, 14 started treatment and 8 completed all seven modules of the program. Between-group analysis showed no significant difference for any outcome measure at any follow-up (all P >.05). Within-group analysis in the iMPP group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: χ2=10.2, P=.04; Wilcoxon: Z=-2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: χ2=20.0, P=.045; Wilcoxon: Z=-2.33, P=.02) and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: χ2=25.1, P=.01; Wilcoxon 3 month: Z=-3.0, P=.003; Wilcoxon 6 month: Z=0.09, P=.001).
Conclusions:
This study was not able to demonstrate a difference in treatment outcome between iMPP and occlusal splint therapy in patients with chronic TMD pain. However, within the iMMP group, this study suggests that iMPP improves jaw function. The results also confirms the treatment effect of occlusal splint therapy in chronic TMD pain. Furthermore, the outcome of this pilot study shows that an RCT with this design is not feasible due to a too high attrition rate. Clinical Trial: ClinicalTrials.gov Identifier: NCT04363762, ID: OSK2016OFRS01; https://clinicaltrials.gov/show/NCT04363762
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