Effects of Cervico-Mandibular Manual Therapy in Patients with Temporomandibular Pain Disorders and Associated Somatic Tinnitus: A Randomized Clinical Trial – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

Delgado de la Serna P, Plaza-Manzano G, Cleland J, Fernández-de-Las-Peñas C, Martín-Casas P, Díaz-Arribas MJ.

Reviewer Name

Angelo Pata SPT

Reviewer Affiliation(s)

Duke University School of Medicine, Doctor of Physical Therapy Division

Paper Abstract

Objective: This randomized clinical trial investigated the effects of adding cervico-mandibular manual therapies into an exercise and educational program on clinical outcomes in individuals with tinnitus associated with temporomandibular disorders (TMDs). Methods: Sixty-one patients with tinnitus attributed to TMD were randomized into the physiotherapy and manual therapy group or physiotherapy alone group. All patients received six sessions of physiotherapy treatment including cranio-cervical and temporomandibular joint (TMJ) exercises, self-massage, and patient education for a period of one month. Patients allocated to the manual therapy group also received cervico-mandibular manual therapies targeting the TMJ and cervical and masticatory muscles. Primary outcomes included TMD pain intensity and tinnitus severity. Secondary outcomes included tinnitus-related handicap (Tinnitus Handicap Inventory [THI]), TMD-related disability (Craniofacial Pain and Disability Inventory [CF-PDI]), self-rated quality of life (12-item Short Form Health Survey [SF-12]), depressive symptoms (Beck Depression Inventory [BDI-II]), pressure pain thresholds (PPTs), and mandibular range of motion. Patients were assessed at baseline, one week, three months, and six months after intervention by a blinded assessor. Results: The adjusted analyses showed better outcomes (all, P < 0.001) in the exercise/education plus manual therapy group (large effect sizes) for TMD pain (η 2 P = 0.153), tinnitus severity (η 2 P = 0.233), THI (η 2 P = 0.501), CF-PDI (η 2 P = 0.395), BDI-II (η 2 P = 0.194), PPTs (0.363 < η 2 P < 0.415), and range of motion (η 2 P = 0.350), but similar changes for the SF-12 (P = 0.622, η 2 P = 0.01) as the exercise/education alone group. Conclusions: This clinical trial found that application of cervico-mandibular manual therapies in combination with exercise and education resulted in better outcomes than application of exercise/education alone in individuals with tinnitus attributed to TMD. Trial registration: ClinicalTrials.gov NCT02850055. Keywords: Manual Therapy; Pain; Physical Therapy; Temporomandibular Pain; Tinnitus.

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

Was the treatment allocation concealed (so that assignments could not be predicted)?

Were study participants and providers blinded to treatment group assignment?

Were the people assessing the outcomes blinded to the participants’ group assignments?

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

Was there high adherence to the intervention protocols for each treatment group?

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

Cannot Determine, Not Reported, or Not Applicable

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

The application of manual therapy, exercise, and education led to superior outcomes for TMD pain intensity, tinnitus severity, tinnitus-related handicap, TMD-related disability, depressive symptoms, pressure pain thresholds, and mandibular range of motion compared to exercise and education alone.

Key Finding #2

The results of this study provide evidence that the combination of cervico-mandibular manual therapies, exercise, and education can be a highly effective treatment option for individuals experiencing tinnitus attributed to TMD.

Key Finding #3

The manual therapy group had larger effect sizes than the exercise/education alone group, indicating a higher degree of clinical significance.

Please provide your summary of the paper

This article, published in Pain Medicine, presents findings from a randomized controlled trial that examined the efficacy of a six-session multimodal physiotherapy program in addressing tinnitus severity, pain intensity, and quality of life in patients with TMD-related tinnitus. The study included 61 participants who were randomly assigned to receive either physiotherapy alone or physiotherapy combined with manual therapy. The results of the study indicate that the group receiving manual therapy, exercise, and education experienced significantly greater improvements in TMD pain, tinnitus severity, tinnitus-related handicap, TMD-related disability, depressive symptoms, pressure pain thresholds, and mandibular range of motion compared to those who received exercise and education alone. The study provides evidence that cervico-mandibular manual therapies can be an effective treatment option for individuals with tinnitus attributed to TMD.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.

The results of this randomized controlled trial provide valuable insights into the potential benefits of incorporating manual therapy in the treatment of patients with TMD-related tinnitus. Clinically, the results of this study highlight the importance of a multimodal approach to treating TMD-related tinnitus. Healthcare providers should consider incorporating manual therapy techniques, specifically those targeting the cervical and masticatory muscles, in combination with exercise and education interventions for their patients. Some of the following exercises were used in this study and may be helpful to future healthcare providers looking for interventions for individuals with TMD-related tinnitus: Inferior glide of the temporomandibular joint, soft tissue mobilization of masseter muscles, and soft tissue mobilization of the temporalis muscle. Additionally, this study provides evidence that a six-session multimodal physiotherapy program can significantly improve symptoms in individuals with TMD-related tinnitus. This information may assist healthcare providers in designing effective treatment plans that can improve patient outcomes and quality of life.