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

Early Phase 1

Recruiting

Interventions: Drug: Botox Injectable Product
Device: Acupuncture needle
Device: Dry needle

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Botox injection (study group C)	Botox Injectable Product	each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms
Acupuncture needle (study group A)	Acupuncture needle	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
Dry needle (study group B)	Dry needle	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

Primary Outcome Measures

Name	Time	Method
change of electrical activity of mastication muscles from the baseline measurement	6 months after treatment	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)

Secondary Outcome Measures

Name	Time	Method
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)	6 months after treatment	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)

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