Comparative effectiveness of traditional Chinese medicine and psychosocial care in the treatment of temporomandibular disorders-associated chronic facial pain

Abstract

This dual-site study sought to identify the appropriate role for traditional Chinese medicine (TCM; acupuncture and herbs) in conjunction with a validated psychosocial self-care (SC) intervention for treating chronic temporomandibular disorders (TMD)-associated pain. Participants with Research Diagnostic Criteria for Temporomandibular Disorders-confirmed TMD (n = 168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, and current pain; each visual analog scale [VAS] 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety. TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, -.60 [standard deviation of the estimate .26], P = .020) and greater reduction in interference with social activities (-.81 [standard deviation of the estimate .33], P = .016). In 2 of 5 treatment trajectory groups, more than two thirds of participants demonstrated clinically meaningful responses (≥30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167).

Perspective: This short-term comparative effectiveness study of chronic facial pain suggests that TCM is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.

Conflict of interest statement

Disclosures:

The authors have no conflicts of interest to declare.

Copyright © 2012 American Pain Society. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

The CONSORT diagram shows the progression of study participants through the first two allocation periods of the study, the short-term component reported here. It illustrates the study design and worst facial pain (WFP) cut-points, and provides the number of participants providing outcome data, beginning with the first allocation. In each group, the number of participants beginning the intervention in that phase is shown as the top number, and the number of evaluable participants at the end of that phase is shown in the bottom number. Details of the reasons for participant losses in each group are shown. Details for the losses in the recruitment process are provided in the text.

Figure 2

This figure illustrates the main short-term outcomes based on protocol-specified analyses for the primary outcomes, characteristic facial pain and worst facial pain. The statistical analysis that corresponds to the overall changes is provided in Table 4. Note that the facial pain values to the left of the arrow for each group represent values at the start of that period, not at study baseline.

Figure 3

This figure illustrates the percent of allocated participants achieving clinically meaningful response (≥ 30% improvement) through 16 weeks on study intervention (weeks 2–18). Left side of panel: Change for patients with high pain levels at baseline and allocated at first point [Tt allocated to TCM at initial time and continued; SS allocated to self-care and then allocated to self-care again; ST allocated to self-care and then allocated to TCM]. Right side of panel: Change for patients with lower (moderate) pain levels [s] at baseline [sS with moderate baseline pain and allocated at week 8 to self-care; sT with moderate baseline pain and allocated at week 8 to TCM]. Sample sizes for each group are shown in Figure 1.