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

Cairo University (CU)

Status and phase: Enrolling; Early Phase 1

Conditions: Myofascial Trigger Point Pain; Myofascial Pain Syndrome

Treatments: Device: Dry needle; Drug: Botox Injectable Product; Device: Acupuncture needle

Study type: Interventional

Funder types: Other

Identifiers

NCT06013644

17223

Details and patient eligibility

About

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

Full 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

Enrollment: 39 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 3 patient groups

Acupuncture needle (study group A)

Active Comparator group

Description:

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

Treatment:

Device: Acupuncture needle

Dry needle (study group B)

Active Comparator group

Description:

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

Treatment:

Device: Dry needle

Botox injection (study group C)

Active Comparator group

Description:

each patient will receive a one time treatment of a suitable dose (estimated by the research team) according to the severity of the symptoms

Treatment:

Drug: Botox Injectable Product