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Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization

Primary Purpose

Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical therapy combined with aerobic exercise
Physical Therapy
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control group

Arm Description

Myogenous 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.

Myogenous 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)

Outcomes

Primary Outcome Measures

Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)
Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon

Secondary Outcome Measures

Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)
Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)
Visual Analog Scale: 100mm (no pain to worst pain)
Change of baseline in Jaw function at 1 month (final) and 3 months (post)
Fonseca Anamnestic Index. 10 questions with a three-point scale: 0 = no, 5 = sometimes and 10 = yes; total score from 0 good function, to 100 worst.
Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)
Millimeter metalic rule to assess opening, lateral and protrusion jaw range of motion
Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)
CROM for global cervical range (flexion, extension, rotations, inclinations)
Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)
Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device
Change of baseline in Neck disability at 1 month (final) and 3 months (post)
Neck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete)
Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)
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)
Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)
Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Change of baseline in Perceived change at 1 month (final) and 3 months (post)
Global Rating of Change scale: 15 points, from -7 (worst) to 7 (best)

Full Information

First Posted
September 6, 2022
Last Updated
January 25, 2023
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05540366
Brief Title
Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization
Official Title
Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome, Endurance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Myogenous 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Myogenous 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)
Intervention Type
Other
Intervention Name(s)
Physical therapy combined with aerobic exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)
Primary Outcome Measure Information:
Title
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)
Description
Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon
Time Frame
Baseline - 2 weeks - 1 month (final) - 3 months
Secondary Outcome Measure Information:
Title
Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)
Description
Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Time Frame
Baseline - 2 weeks - 1 month (final) - 3 months post
Title
Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)
Description
Visual Analog Scale: 100mm (no pain to worst pain)
Time Frame
Baseline - 2 weeks - 1 month (final) - 3 months posts
Title
Change of baseline in Jaw function at 1 month (final) and 3 months (post)
Description
Fonseca Anamnestic Index. 10 questions with a three-point scale: 0 = no, 5 = sometimes and 10 = yes; total score from 0 good function, to 100 worst.
Time Frame
Baseline - 1 month (final) - 3 months post
Title
Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)
Description
Millimeter metalic rule to assess opening, lateral and protrusion jaw range of motion
Time Frame
Baseline - 1 month (final) - 3 months posts
Title
Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)
Description
CROM for global cervical range (flexion, extension, rotations, inclinations)
Time Frame
Baseline - 1 month (final) - 3 months post
Title
Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)
Description
Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device
Time Frame
Baseline - 2 weeks - 1 month (final) - 3 months posts
Title
Change of baseline in Neck disability at 1 month (final) and 3 months (post)
Description
Neck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete)
Time Frame
Baseline - 1 month (final) - 3 months posts
Title
Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)
Description
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)
Time Frame
Baseline - 1 month (final) - 3 months posts
Title
Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)
Description
Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Time Frame
Baseline - 1 month (final) - 3 months posts
Title
Change of baseline in Perceived change at 1 month (final) and 3 months (post)
Description
Global Rating of Change scale: 15 points, from -7 (worst) to 7 (best)
Time Frame
Baseline - 1 month (final) - 3 months posts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flora Dantony
Phone
+34601533951
Email
fdantony@uic.es
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora Dantony

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization

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