Temporomandibular Joint Disorders Clinical Trial
Official title:
Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders. A Randomized Controlled Trial.
Verified date | May 2022 |
Source | University of Jaén |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Temporomandibular Joint Disorders (TJD) represent a set of conditions that involve pain and dysfunction of the temporomandibular joint. TJD are a frequent disability affection in the worldwide population and the 35% of affected present at least a symptom such as orofacial pain, mouth movement limitations and snapping or crying temporo-mandibular. Due to the increase of the incidence of the TJD the investigators propose to complete this study. A randomized controlled trial with parallel groups have been designed and blind evaluation of the response variable. The hypothesis is that dry needling produces a positive effect in the involved variables of this study in comparison with manual therapy. The aim of this RCT is to compare the effectiviness of the application of manual therapy in comparison with dry needling in the perceived pain, mouth opening, the degree of cervical disability and the pressure-pain threshold (PPT) of myofascial trigger points (MTrP) in patiens with TJD.
Status | Completed |
Enrollment | 46 |
Est. completion date | November 11, 2020 |
Est. primary completion date | September 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: Female and male subjects with an age of 18-65 years old with a TJD who meet at least two of the following inclusion criteria: - Pain on palpation of the myofascial trigger points of the masseter, anterior temporal, posterior temporal, external pterygoid and sternocleidomastoid muscles (minimum 3 active trigger points). - Pain in the temporomandibular joint. - Limitation of mouth opening. - Clicking of the temporomandibular joint. Exclusion Criteria: Subjects who present any of the following characteristics: - fibromyalgia, orthodontia, systemic disease, syndrome or pathology with possible joint repercussions, patients undergoing treatment with NSAIDs, jaw fracture, mandibular surgery, non-collaborative patients or patients with phobia needles. |
Country | Name | City | State |
---|---|---|---|
Spain | Clínica de Fisioterapia y Rehabilitación Miophys S.C.A. | Córdoba |
Lead Sponsor | Collaborator |
---|---|
University of Jaén |
Spain,
Blasco-Bonora PM, Martín-Pintado-Zugasti A. Effects of myofascial trigger point dry needling in patients with sleep bruxism and temporomandibular disorders: a prospective case series. Acupunct Med. 2017 Mar;35(1):69-74. doi: 10.1136/acupmed-2016-011102. E — View Citation
Gonzalez-Perez LM, Infante-Cossio P, Granados-Nunez M, Urresti-Lopez FJ, Lopez-Martos R, Ruiz-Canela-Mendez P. Deep dry needling of trigger points located in the lateral pterygoid muscle: Efficacy and safety of treatment for management of myofascial pain — View Citation
Pessoa DR, Costa DR, Prianti BM, Costa DR, Delpasso CA, Arisawa EÂLS, Nicolau RA. Association of facial massage, dry needling, and laser therapy in Temporomandibular Disorder: case report. Codas. 2018 Nov 29;30(6):e20170265. doi: 10.1590/2317-1782/2018201 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic variables | At the beginning of the treatment, the first day. | ||
Primary | Pain intensity | Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), | At the beginning of treatment, the first day | |
Primary | Change from Baseline Pain intensity | Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), | At the ended of the first session, after an hour. | |
Primary | Change from Baseline Pain intensity | Pain Numeric Rating Scale to assess the intensity of the temporomandibular pain level in patients with TJD. Patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), | At the end of treatment, an average of 2 weeks. | |
Primary | Pain after trigger points pressure | It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us. | At the beginning of treatment, the first day | |
Primary | Change from Baseline Pain after trigger points pressure | It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us. | At the ended of the first session, after an hour. | |
Primary | Change from Baseline Pain after trigger points pressure | It will be measured by pressure algometry with the Wagner Force Ten model FDX algometer. Thus, a numerical value will be provided for the subjective perception of pain. The unit of measurement used is Kg / cm2. Once the trigger point is located within the taut band, pressure will be exerted perpendicular to the muscle plane and on the PGM through the support surface of the device. We increase the pressure at a constant rate of 1 kg / cm2 / s. When the pressure becomes a painful stimulus, the individual must raise his hand to warn us. | At the end of treatment, an average of 2 weeks | |
Primary | Open mouth movements | It will be measured with a validated ruler in centimeters. | At the beginning of treatment, the first day | |
Primary | Change from Baseline open mouth movements | It will be measured with a validated ruler in centimeters. | At the ended of the first session, after an hour. | |
Primary | Change from Baseline open mouth movements | It will be measured with a validated ruler in centimeters. | At the end of the tratment, an average of 2 weeks | |
Primary | Neck Disability Index | It will measured with the Spanish version of the Neck Disability Index. The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Higher scores mean a worse outcome. | At the beginning of treatment, the first day. | |
Primary | Change from Baseline Neck Disability Index | It will measured with the Spanish version of the Neck Disability Index. The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. Higher scores mean a worse outcome. | At the end of the treatment, an average of 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03675659 -
Intra-articular Magnesium Sulfate for Tmj Dysfunction
|
Early Phase 1 | |
Completed |
NCT05740826 -
Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
|
||
Recruiting |
NCT05006963 -
Tele-Rehabilitation in Patients With Temporomandibular Dysfunction
|
N/A | |
Active, not recruiting |
NCT06103851 -
Effect of Mask Use on Jaw Functionality
|
||
Not yet recruiting |
NCT02908568 -
Stimulation of the Proprioceptive Trigeminocardiac Reflex
|
Phase 2/Phase 3 | |
Completed |
NCT03119324 -
Low Level Laser Therapy in the Treatment of Temporomandibular Joint Disorders (TMJDs) Related Pain
|
N/A | |
Completed |
NCT02247063 -
Motor Cortex as a Research & Therapeutic Target in TMD
|
N/A | |
Recruiting |
NCT06046521 -
Impact of Temporomandibular Joint Dysfunction on Objective and Subjective Vocal Measures
|
||
Completed |
NCT00009594 -
Alternative Medicine Approaches for Women With Temporomandibular Disorders
|
Phase 2 | |
Completed |
NCT00010621 -
Complementary Medicine Approaches to TMD Pain Management
|
Phase 2 | |
Completed |
NCT06055855 -
Comparing Two-Needle vs. Surgery-Guided Arthrocentesis for TMJ Disorders
|
N/A | |
Not yet recruiting |
NCT06259344 -
Pain Science Education Administered in Full or Fractioned Dosage Modes for Temporomandibular Disorders
|
N/A | |
Recruiting |
NCT06035341 -
The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction
|
N/A | |
Completed |
NCT06005922 -
The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain
|
N/A | |
Completed |
NCT05821985 -
Evaluation of the Effect of Dextrose Prolotherapy Versus Dry Needling Therapy
|
N/A | |
Completed |
NCT06034756 -
Temporomandibular Joint Problems and Core Stabilization
|
||
Completed |
NCT03576079 -
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
|
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 |
NCT04477122 -
Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.
|
N/A | |
Completed |
NCT00237042 -
Managing Temporomandibular Disorder (TMD) Symptoms
|
N/A |