Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05540366
Other study ID # Flora Dantony
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date June 30, 2023

Study information

Verified date January 2023
Source Universitat Internacional de Catalunya
Contact Flora Dantony
Phone +34601533951
Email fdantony@uic.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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)

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat Del Vallès

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline - 2 weeks - 1 month (final) - 3 months
Secondary 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) Baseline - 2 weeks - 1 month (final) - 3 months post
Secondary 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) Baseline - 2 weeks - 1 month (final) - 3 months posts
Secondary 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. Baseline - 1 month (final) - 3 months post
Secondary 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 Baseline - 1 month (final) - 3 months posts
Secondary Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post) CROM for global cervical range (flexion, extension, rotations, inclinations) Baseline - 1 month (final) - 3 months post
Secondary 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 Baseline - 2 weeks - 1 month (final) - 3 months posts
Secondary 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) Baseline - 1 month (final) - 3 months posts
Secondary 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) Baseline - 1 month (final) - 3 months posts
Secondary 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. Baseline - 1 month (final) - 3 months posts
Secondary 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) Baseline - 1 month (final) - 3 months posts
See also
  Status Clinical Trial Phase
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Completed NCT04102306 - Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
Not yet recruiting NCT05297604 - Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders Phase 2
Recruiting NCT03849534 - Treatment of Temporomandibular Disorders in Children and Adolsecents N/A
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Not yet recruiting NCT05021874 - The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures. N/A
Recruiting NCT05232604 - How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain? N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT03726060 - Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders N/A
Not yet recruiting NCT06123351 - Forward Head Posture Correction Impact on Temporomandibular Dysfunction N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT01000389 - A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism N/A
Completed NCT00743223 - The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder N/A
Completed NCT03300297 - Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder N/A
Completed NCT06065826 - Forward Head Posture and Myogenic TMD Association in Smartphone Overuse
Completed NCT04087005 - Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial N/A
Recruiting NCT03696706 - Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction Phase 2
Completed NCT04041271 - Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
Recruiting NCT03096301 - Photobiomodulation in Temporomandibular Disorder N/A
Not yet recruiting NCT06052722 - The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders N/A