Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders. A Randomized Controlled Trial.

Conditions
-----------------
Temporomandibular Joint Disorders, Dry Needling, Musculoskeletal Manipulations

Intervention / Treatment
-----------------
* Other: Dry needling
* Other: Manual Therapy Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dry Needling Group<br> | Other: Dry needling<br>* Twenty-three patients with TJD will be allocated in Dry Needling Group. They will receive 3 sessions of dry needling separated for 4 days. This treatment will consist of puncturing the active myofascial trigger points (PGM) of the aforementioned muscles. Sterile acupuncture needles of 0.26 mm in diameter by 40 mm in length, guided with a plastic cannula of the Ener-qi brand, will be used. The area will be cleaned with alcohol and a deep puncture of the PGM will be performed, triggering local spasm responses. Needle through the muscle following the technique described by Hong (Hong et al. 1994). After the procedure, the area is compressed with cotton for 90 seconds.<br>|
| Active Comparator: Manual Therapy Treatment<br> | Other: Manual Therapy Treatment<br>* Twenty-three patients will be allocated in Manual Therapy (MT) Group for three sessions during 30 minutes. MT treatment will consist in the application of neuromuscular techniques of the temporal, masseter and sternocleidomastoid muscles and Jones techniques in the external pterygoid muscle. Neuromuscular techniques are performed with the index and major fingers to apply a transverse friction with enough pressure to feel vertical fibers of each muscle or produce a medium discomfort level. To perform the Jones technique on the external pterygoid muscle, the patient will be asked to open the mouth and deviate the jaw slightly towards the treated side in order to make room for the finger to be located between the upper jaw and the coronoid process. Once the trigger point is located, we press to trigger the pain and we look for neurological silence and we maintain the pressure for 90 seconds. Over time, we slowly withdraw the pressure and return to the position passively.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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 | 
| 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. | 
| 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 | 
| Open mouth movements | It will be measured with a validated ruler in centimeters. | At the beginning of treatment, the first day | 
| 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. | 
| 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 | 
| 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. | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Temporomandibular joint disorders, Dry Needling, Manual Therapy, Orofacial disability, Neck Pain