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

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

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

Study Overview

• Status: Recruiting
• Conditions: Myofascial Pain Syndrome; Myofascial Trigger Point Pain
• Intervention / Treatment: Device: Acupuncture needle; Device: Dry needle; Drug: Botox Injectable Product

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

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Wajma Sayed Karim Al Sayed
    • Contact: Wajma Alsayed; Phone Number: 01004762274; Email: wajmah.sayed@dentistry.cu.edu.eg
    • Contact: Phone Number: +201001545449; Email: Hassan_ao@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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
Active Comparator: 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	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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction questionnaire	Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction	2 months after treatment
Patient Satisfaction questionnaire	Score of 1 to 10 where (1 means least satisfaction and 10 means most satisfaction	6 months after treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: acupuncture; botox injection; myofascial trigger point pain; dry needle
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 17223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All the study data will be available upon publication after completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No