Effects of Aerobic Exercise on Pain in Patients With Myogenic Temporomandibular Disorders

Sponsor
Universitat Internacional de Catalunya (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05540366
Collaborator
(none)
20
2
5

Study Details

Study Description

Brief Summary

Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical therapy combined with aerobic exercise
  • Other: Physical Therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Aerobic Exercise on Pain in Patients With Myogenic Temporomandibular Disorders: A Pilot Randomized Controlled Trial
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Myogenic temporomandibular subjects Physical therapy combined with aerobic exercise: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike.

Other: Physical therapy combined with aerobic exercise
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike.

Active Comparator: Control group

Myogenic temporomandibular subjects Physical Therapy: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)

Other: Physical Therapy
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)

Outcome Measures

Primary Outcome Measures

  1. Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post) [Baseline - 2 weeks - 1 month (final) - 3 months]

    Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon

Secondary Outcome Measures

  1. Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post) [Baseline - 2 weeks - 1 month (final) - 3 months post]

    Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)

  2. Change of baseline in Jaw function at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months post]

    Helkimo Index: range of movement, pain and function. From 0 to 25 (0=no TMD; 1-9= mild TMD; 10-19= moderate TDM; 20-25=severe TMD)

  3. Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months post]

    CROM for global cervical range (flexion, extension, rotations, inclinations)

  4. Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post) [Baseline - 2 weeks - 1 month (final) - 3 months posts]

    Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device

  5. Change of baseline in Neck disability at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months posts]

    Neck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete)

  6. Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months posts]

    Hospital Anxiety and Depression Scale: 2 subscales, one for anxiety and the other one for depression. Each scale score is from 0 (less) to 21 (worst)

  7. Change of baseline in Sleep Quality at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months posts]

    Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.

  8. Change of baseline in Perceived change at 1 month (final) and 3 months (post) [Baseline - 1 month (final) - 3 months posts]

    Global Rating of Change scale: 15 points, from -7 (worst) to 7 (best)

  9. Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post) [Baseline - 2 weeks - 1 month (final) - 3 months posts]

    Visual Analog Scale: 100mm (no pain to worst pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.

  • A minimum score of 30 in the Central Sensitization Index

  • Positive FRT

Exclusion Criteria:
  • History of trauma, TMJ or cervical fracture the past three months

  • History of TMJ or cervical surgery

  • Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant

  • History of cardiovascular diseases which contraindicate aerobic exercise

  • Current orthodontic treatment, splints for bruxism

  • Drug addiction, alcoholism

  • Pregnancy

  • Use of analgesic medication less than 48 hours before each data collection

  • Physical therapy treatment during the past three months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitat Internacional de Catalunya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Flora Dantony, Physical therapy department, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier:
NCT05540366
Other Study ID Numbers:
  • Flora Dantony
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2022