Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Myofascial Pain Dysfunction Syndrome

NCT06583915 | Not Yet Recruiting

• 1 other identifier: OMFS333
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myofascial pain dysfunction syndrome (MPDS) is the most common form of temporomandibular disorders. Because of the multifactorial nature of the problem, its management is still not definite. This randomized clinical trial aimed to assess the efficacy of transcutaneous electrical nerve stimulation over dry needling for management of such condition.

Conditions

Myofascial Pain - Dysfunction Syndrome of TMJ

Outcome Measures

Primary Outcomes (1)

• Pain

  Using visual analogue scale (VAS) from (1-10) where 1 is the least pain and 10 is the maximum pain

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (5)

• Muscle stiffness

  From enrollment to the end of treatment at 6 months

• Limitation in mouth openinig

  From enrollment to the end of treatment at 6 months

• Sleeping disorder

  From enrollment to the end of treatment at 6 months

• Anxiety

  From enrollment to the end of treatment at 6 months

• Patient satisfaction

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Transcutaneous electrical nerve stimulation

EXPERIMENTAL

Low voltage electrical pulses that are applied to the central nervous system

Procedure: TENS

Dry Needling

ACTIVE COMPARATOR

insertion of a solid filiform needle into a trigger point without the administration of any substance

Procedure: Dry Needle

Interventions

TENS PROCEDURE

Non-pharmacological method which is widely used by medical and paramedical professionals for the management of acute and chronic pain using electric pulse generator, lead wires and electrodes.

Transcutaneous electrical nerve stimulation

Dry Needle PROCEDURE

Invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle.

Dry Needling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients complaining of pain in muscles of mastication lasting for three months or more.
• Presence of trigger points in the temporalis, masseter or lateral pterygoid muscle identified by clinical examination and palpation.
• Average pain severity of at least 4 on a 10-point scale
• Pain in pre-auricular area, or in the ear during rest or function

You may not qualify if:

• No previous tempro-mandibular joint (TMJ) surgical intervention
• Patients with neurological disorders, coagulopathy, vascular disease autoimmune disease (systemic lupus, rheumatoid arthritis), fibromyalgia
• Pregnancy
• Current opioid use
• Intake of analgesics, muscle relaxant, anti-inflammatory medications such as NSAID's and benzodiazepines,
• Patients with severe trauma or infections in TMJ
• Tempro-mandibular dysfunction (TMD) with joint origin (any type of internal derangement)

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Mostafa ElGengehy, PhD

  Professor, Department of oral and maxillofacial surgery

  STUDY CHAIR

Central Study Contacts

Mostafa ElGengehy, PhD

CONTACT

+201221089223; mostafa.elgengehe@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Student, Department of oral and maxillofacial surgery

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 4, 2024
• Study Start: December 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share