Neck Exercises in Patients With Temporomandibular Disorders

NCT03403998 | Completed

• 1 other identifier: Pro00073078
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Musculoskeletal (MSK) pain is a common reason to seek medical treatment. Temporomandibular disorders (TMDs) are MSK disorders that affect the masticatory muscles, the temporomandibular joint, and related structures in the neck and head. Current research showed that people with chronic TMDs have structural and functional brain changes that may contribute to chronic pain development and maintenance. Therapeutic exercise is a central component in treating chronic MSK conditions. New therapies, including exercise, appear to have potential in targeting cortical changes to improve clinical outcomes. However, mechanisms of action are not well understood, and evidence is limited to a few weak studies and specific populations. Evidence from our research group highlights neck exercise as potentially useful in treating TMDs. However, we do not yet know how the brains of women with TMD respond to specific exercise and whether these changes relate to decreased pain, improved function, and quality of life. Evidence linking brain plasticity, pain modulation, and exercise therapy is currently limited, and non-existent for people with TMDs. Objectives: In women with chronic TMD pain, we will:1) determine the impact of motor control training using visual feedback (MCTF) on clinical outcomes such as pain intensity and jaw disability, 2) assess the impact of MCTF on brain structure, using diffusion tensor imaging, 3) assess the impact of MCTF on brain networks, using resting state functional magnetic resonance imaging, and 4) determine the effectiveness of MCTF to restore normal muscular structure, performance and fatigability of neck cervical muscles, using electromyographic analysis. Methods: Women with chronic TMD pain will be randomized to either an intervention arm or a placebo control group. Women in the intervention arm will receive 8 weeks of progressive exercise MCTF of the cervical muscles, twice per week. Women in the placebo arm will receive innocuous transcutaneous electrical nerve stimulation (turn off). Our primary outcomes will be changes in 1) pain, measured with the Visual Analogue Scale, 2) brain structure and networks, measured by fractional anisotropy (brain structure) and the blood-oxygen-level dependent signal (brain networks). Outcomes will be measured at baseline, after 8 weeks of treatment, and 4 months after treatment ends. Results will directly inform and guide clinicians in prescribing more effective interventions for women with TMD

Conditions

Temporomandibular Disorders; Temporomandibular Joint Pain

Keywords

Pain; Temporomandibular Disorders; Therapeutic exercises; Musculoskeletal disorders; Randomized controlled trial; Imaging; Brain plasticity; Clinical outcomes; Chronic pain; Neck

Outcome Measures

Primary Outcomes (3)

• Pain Intensity measured with a Visual Analogue Scale (VAS)

  The VAS is a linear scale 10 cm in length, labeled with the two extremes boundaries of pain sensation: "no pain", at one end and "worst pain imaginable" at the other end. The validity and reliability of these methods for determining pain intensity, has been reported and confirmed in the literature

  Change from baseline at 2 months ( change from baseline at 6 months )

• Fractional Anisotropy (FA)

  To analyze the DTI images, we will use a method similar to Moayedi et al. To analyze the rsfMRI images, we will use the pipeline outlined in Greicius et al.in addition to applying functional connectivity (graphical modelling) as previously used in our lab. Images will be imported into the software library (FSL v. 4.1.8) of the Oxford Centre for Functional MRI of the Brain (FMRIB). Preprocessing will include current and motion artifact correction using the FMRIB Diffusion Toolbox v. 2.0. The DTI images will be processed through 2 different pipelines for 1) voxel-wise analysis and 2) tractography. The preprocessed images will be fit with a diffusion tensor model using DTIFIT in the FDT. We then will calculate voxel-wise values of FA. The rsfMRI images will be analyzed using an ICA approach to isolate the DMN and the sensorimotor network and a functional connectivity approach using graphical modelling to assess the neural networks associated with TMD treatment.

  Change from baseline at 2 months (change from baseline at 6 months (if budget allows))

• functional brain networks

  To analyze the DTI images, we will use a method similar to Moayedi et al. To analyze the rsfMRI images, we will use the pipeline outlined in Greicius et al.in addition to applying functional connectivity (graphical modelling) as previously used in our lab. Images will be imported into the software library (FSL v. 4.1.8) of the Oxford Centre for Functional MRI of the Brain (FMRIB). Preprocessing will include current and motion artifact correction using the FMRIB Diffusion Toolbox v. 2.0. The DTI images will be processed through 2 different pipelines for 1) voxel-wise analysis and 2) tractography. The preprocessed images will be fit with a diffusion tensor model using DTIFIT in the FDT. We then will calculate voxel-wise values of FA. The rsfMRI images will be analyzed using an ICA approach to isolate the DMN and the sensorimotor network and a functional connectivity approach using graphical modelling to assess the neural networks associated with TMD treatment.

  Change from baseline at 2 months (change from baseline at 6 months (if budget allows))

Secondary Outcomes (13)

• Jaw function

  Change from baseline at 2 months ( change from baseline at 6 months )

• Neck Flexor Endurance Test

  Change from baseline at 2 months ( change from baseline at 6 months )

• Neck Extensor Endurance Test:

  Change from baseline at 2 months ( change from baseline at 6 months )

• Craniocervical Flexion Test (CCFT)

  Change from baseline at 2 months ( change from baseline at 6 months )

• Global Rating Scale (GRS)

  Change from baseline at 2 months ( change from baseline at 6 months )

Study Arms (2)

Exercises

EXPERIMENTAL

Neck flexors Training: Each patient will initially perform cranio-cervical flexion to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the contraction duration will be increased to 10 s, and the participant trained to perform 10 repetitions with brief rest periods between each contraction. Once one set of 10 repetitions of 10 s is achieved at one target level, the exercise will be progressed to train at the next target level up to the final target. Neck extensors training: Patients will perform cranio-cervical extension and upper cervical rotation in a prone on elbows position while maintaining the cervical spine in a neutral position, progressing to a 4-pt kneeling position.

Other: Exercises

Placebo

PLACEBO COMPARATOR

The placebo group will receive placebo TENS (switched-off TENS apparatus with no perceptible stimulation). Four electrodes, 50 x 35 mm, will be placed on the neck muscles. The participant will be informed that this therapy is called a "subthreshold current" and they might not be able to feel any sensation underneath the electrodes during the treatment. The placebo treatment will be for 30 min twice a week for 8 weeks, as for the intervention group.

Other: Placebo

Interventions

Exercises OTHER

The treatment will consist of an 8-week progressive exercise program of neck flexors and extensors exercises supervised by a physical therapist for 30-45 min twice a week per 8 weeks as described in Arm/group descriptions.

Exercises

Placebo OTHER

The placebo treatment will be for 30-45 min twice a week for 8 weeks, as for the intervention group. ( see details in arm description)

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• females 18-60 years of age (TMDs are more prevalent in females);
• diagnosed with muscle pain disorders as classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) or mixed TMD;
• have had pain in the masticatory muscle for at least 3 months;
• have chronic masticatory muscle pain not attributable to recent acute trauma, previous infection, or active inflammation; and
• have a moderate or severe baseline pain score of 30 mm or greater using a 100 mm VAS.

You may not qualify if:

• metabolic, rheumatoid, or vascular diseases;
• commonly comorbid functional chronic pain disorders (e.g., irritable bowel syndrome, fibromyalgia);
• psychiatric disorders (e.g., depression, schizophrenia);
• abnormal neurological examination;
• contraindication for MRI scanning (e.g., metallic surgical implant);
• self-report of substance abuse;
• exercise therapy in the 6 months before entry into the study or current treatment for TMD;
• previous experience with electrotherapy; or
• pregnant or planning a pregnancy.
• After confirming eligibility to participate in the study, all participants will be asked to sign an informed consent in accordance with the UofA´s policies on research using human participants.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Corbett Hall-Sports Laboratory

Edmonton, Alberta, T6G 0V1, Canada

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain; Musculoskeletal Diseases; Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Susan Armijo-Olivo, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients (reporting one of the main outcome for this study - pain) will be unaware of the hypothesis of this study and performance biases will be avoided by telling them that both treatment options have similar effectiveness. Assessors (measuring clinician assessed tests) and Statistician will be blinded to hypothesis and group allocation following established guidelines.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomization sequence will be computer-generated by a research assistant (RA) not involved in the study. To ensure concealment, the RA will distribute the results of the sequence to the therapist in consecutively numbered, opaque, and sealed envelopes. Participants will be unaware of the study hypothesis. Assessors (who will measure clinician-assessed tests and analyze imaging outcomes) and the statistician will be blinded to the hypothesis and group allocation, following established guidelines. Participants randomized to the treatment group will receive MCTF as described in the Intervention section. Participants randomized to the placebo group will receive placebo transcutaneous electrical nerve stimulation (TENS) as described in the Intervention section

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 19, 2018
• Study Start: January 17, 2018
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CA (1)