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

NCT06013644 | Unknown Early Phase 1 DMC

• 1 other identifier: 17223
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Myofascial Trigger Point Pain; Myofascial Pain Syndrome

Keywords

botox injection; dry needle; myofascial trigger point pain; acupuncture

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

  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)

  6 months after treatment

Other Outcomes (2)

• Patient Satisfaction questionnaire

  2 months after treatment

• Patient Satisfaction questionnaire

  6 months after treatment

Study Arms (3)

Acupuncture needle (study group A)

ACTIVE COMPARATOR

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

Dry needle (study group B)

ACTIVE COMPARATOR

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

Botox injection (study group C)

ACTIVE COMPARATOR

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

Interventions

Acupuncture needle 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

Acupuncture needle (study group A)

Dry needle 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

Dry needle (study group B)

Botox Injectable Product 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

Botox injection (study group C)

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Wajma Sayed Karim Al Sayed

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 28, 2023
• Study Start: June 3, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 28, 2023

Record last verified: 2023-08

Locations

EG (1)