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Clinical Trial NCT06584526 for Temporomandibular Disorders (TMD), Nociplastic Pain, Aerobic Exercise, Strengthening Exercises, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders 51 Exercise-Based Remote

Not yet recruiting
Clinical Trial NCT06584526 is an interventional study for Temporomandibular Disorders (TMD), Nociplastic Pain, Aerobic Exercise, Strengthening Exercises, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint and is currently not yet recruiting. Enrollment is planned to begin on 9 September 2024 and continue until the study accrues 51 participants. Led by Universitat Internacional de Catalunya, this study is expected to complete by 31 July 2025. The latest data from ClinicalTrials.gov was last updated on 4 September 2024.
Brief Summary
Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in ...Show More
Detailed Description
Introduction: Temporomandibular disorders used to improve with education manual therapy and therapeutic exercise. However, despite the evidence oh nociplastic pain in these patients, the treatments remain local. As aerobic and strength exercice have hypoalgesic effect in chronic musculoskeletal pain, we aim to study the effects combined with a common physical therapy programme on nociplastic pain in patients with tem...Show More
Official Title

Effects of Aerobic and Strength Exercice on Nociplastic Pain in Patients with Temporomandibular Disorders: a Randomized Controlled Trial.

Conditions
Temporomandibular Disorders (TMD)Nociplastic PainAerobic ExerciseStrengthening ExercisesMyofascial Pain Dysfunction Syndrome, Temporomandibular Joint
Other Study IDs
  • FIS-2024-05
NCT ID Number
NCT06584526
Start Date (Actual)
2024-09-09
Last Update Posted
2024-09-04
Completion Date (Estimated)
2025-07-31
Enrollment (Estimated)
51
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorPhysical Therapy (PT)
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups). Education: a series of recommendations to correct inappropriate behaviors such as parafunctions. Manual therapy: * Bilateral myofascial pressure of 60'' applied to the masseter, temporalis, sternocleidomastoid, and upper trapezius muscl...Show More
Physical Therapy
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups).
ExperimentalPhysical Therapy and Aerobic Exercise (PT+AE)
Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes aerobic exercise programme on a cycle ergometer. The AE will consist of: * Warm-up: Participants cycled for 5 min at a heart rate reserve (HRR) of 50%. * Main work: For 24 min, participants performed an interval exercise divided into...Show More
Physical Therapy and 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 cycle ergometer.
ExperimentalPhysical Therapy and Strength Exercise (PT+ST)
Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes strength exercise (ST) programme. The ST exercise will consist of: * Warm-up (5'): circuit, 3 sets of: jumping jacks (20''), mountain climbers (20''), abdominal crunch (20''), active stretching of the quadriceps (20''). * Main work: ...Show More
Physical Therapy and Strength Exercise
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes strength exercise programme.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)
Bilateral measure with digital algometer, applying a perpendicular pressure of 0.5 kg/cm2/s on: masseter, temporal, upper trapezius, SCOM, quadriceps tendon, achilles Tendon.
Baseline - 6 weeks (final) - 12 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (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
Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)
Handgrip strength will be assessed with a Jamar dynamometer, maximal isometric strength, 2 times. Maximal strength of upper trapezius, quadriceps and gastrocnemius will be assessed with a digital dynamometer ActivForce, maximal isometric strength, 2 times. Before assessing strength, a 10 minutes warm up of the muscles will be done: * Upper trapezius: shoulder elevations * Quadriceps: squat * Gastrocnemius: heel elevations * Handgrip: press a ball
Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)
Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device.
Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)
Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)
Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor.
Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (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 - 6 weeks (final) - 12 weeks
Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)
Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)
Tampa Scale of Kinesiophobia: from 10 to 40 (Likert scale 4 points: 1 = totally disagree; 2 = disagree; 3 = agree; 4 = totally agree). Cut-off: 23.
Baseline - 6 weeks (final) - 12 weeks
Adherence at 6 weeks (final) and 12 weeks (post)
ATTEMPT questionnaire to evaluate adherence to exercises post-intervention. 6 items, Likert scale 5 punts ( 1 = totally disagree; 2 = disagree; 3 = neutral; 4 = agree; 5 = totally agree). From 6 to 30, a change of 4 indicates a change.
6 weeks (final) - 12 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
  • Chronic pain (>3months)
  • Nociplastic pain
  • Positive Flexion Rotation Test
  • Be physically able to realize aerobic and strength exercise (functional movement test)

  • 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 month
Universitat Internacional de Catalunya logoUniversitat Internacional de Catalunya
Study Responsible Party
Flora Dantony, Principal Investigator, Principal Investigator, Universitat Internacional de Catalunya
Study Central Contact
Contact: Flora Dantony, Physical Therapist, Msc, +34601533951, [email protected]
1 Study Locations in 1 Countries

Catalonia

Universitat Internacional de Catalunya, Sant Cugat del Vallès, Catalonia, 08192, Spain
Flora Dantony, PT, Msc, Contact, +34601533951, [email protected]