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

NCT ID: NCT06013644

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-03
• Study Completion Date: 2024-02-01

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

Conditions

Myofascial Trigger Point Pain; Myofascial Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acupuncture needle (study group A)

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

Group Type: ACTIVE_COMPARATOR

Acupuncture needle

Intervention Type: DEVICE

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)

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

Group Type: ACTIVE_COMPARATOR

Dry needle

Intervention Type: DEVICE

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

Botox injection (study group C)

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

Group Type: ACTIVE_COMPARATOR

Botox Injectable Product

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Wajmah Sayed Karim Al Sayed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Wajma Sayed Karim Al Sayed

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Wajma Alsayed

Role: primary

wajmah.sayed@dentistry.cu.edu.eg

01004762274

Role: backup

Hassan_ao@yahoo.com

+201001545449

Other Identifiers

17223

Identifier Type: -

Identifier Source: org_study_id