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

Myofascial Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013644
• Other study ID #: 17223
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 3, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Syndrome
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• 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
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

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Wajma Sayed Karim Al Sayed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction questionnaire	Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction	2 months after treatment
Other	Patient Satisfaction questionnaire	Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction	6 months after treatment
Primary	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
Primary	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	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
Secondary	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