Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome

Study Overview
=================
Brief Summary
-----------------
Evaluating myofascial pain dysfunction symptoms using acupuncture, dry needle and Botox injection using electromyography and visual Analogue Scale on two time intervals at 2 and 6 months after the intervention

Detailed Description
-----------------
All the patients will be selected and examine from the outpatient clinic of Oral and Maxillofacial surgery department. Faculty of Dentistry, Cairo University, Egypt. Electromyography examination will be conducted in the department of neurophysiology department. faculty of Medicine, Cairo University, Egypt. Adult patients of both sexes, aged from 15 to 60 years with myofascial pain dysfunction syndrome complaining from sign and symptoms of pain or muscles spams and examination shows trigger points in masticatory muscles. selected patients must have not received any other form of surgical treatment related to TMJ disorders All patients involved in this study will be divided into three groups, each group will receive a technique for one side of MPDS, involving acupuncture, dry needle, and Botox injection. for both, acupuncture group and dry needling group, patients should receive a session/week for 4-6 weeks

Official Title
-----------------
Comparative Efficacy of Acupuncture, Dry Needle and Botox Injection in Management of Patient With Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: A Randomized Clinical Trial

Conditions
-----------------
Myofascial Trigger Point Pain, Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Device: Acupuncture needle
* Device: Dry needle
* Drug: Botox Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Accepts Healthy Volunteers Inclusion Criteria: Healthy Volunteers MPDS patient Adult patients of both sexes, aged from 15 to 60 years signs and symptoms of pain or muscles spams Trigger points in masticatory muscles Patients had not received any other form of surgical treatment related to TMJ disorders Cooperative patient Exclusion Criteria: Severe bleeding tendency, e.g. anticoagulant therapy, thrombocytopenia Edentulous patients, and total dental prosthesis. Psychologically disturbed and mental disturbance patients major systemic disorders (- Valvular heart disease: avoid indwelling needles) seizure patients A confirmed or suspected diagnosis of an inflammatory disorder and autoimmune. Patient on Medication (insulin- corticosteroids, nonsteroidal anti-inflammatory therapy or narcotics, muscle relaxants, herbal medicines.) Analgesic or anti-depressants over the last 2 weeks. Any anatomical abnormality in TMJ. Pregnant women. Allergies to metals.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acupuncture needle (study group A)<br>a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2 | Device: Acupuncture needle<br>* a weekly session for 4-6 weeks on needle for each acupoint for at least 20 minutes the included acupoints are ST6, ST7, SI 18, ST 19, GB 2<br>|
| Active Comparator: Dry needle (study group B)<br>a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes | Device: Dry needle<br>* a weekly session for 4-6 weeks the trigger point is held by thumb and index fingers and the needle approaches the point perpendicular to the skin and rotated clockwise for 2-3 minutes<br>|
| Active Comparator: Botox injection (study group C)<br>each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms | Drug: Botox Injectable Product<br>* each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of electrical activity of mastication muscles from the baseline measurement | change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching) | 2 months after treatment | 
| change of electrical activity of mastication muscles from the baseline measurement | change of electrical activity of mastication muscles from the baseline measurement through assessment of muscle tone using electromyography (EMG) in microvolts and refer to the behavior of muscles: at (rest /open, chewing, clenching) | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible) | change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible) | 2 months after treatment | 
| change of Pain perception from baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible) | change of Pain perception from the baseline measurement during maximum mouth opening in millimetres and rest by a Visual Analog Score (where Zero means no pain and 10 means the worst pain possible) | 6 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botox injection, dry needle, myofascial trigger point pain, acupuncture