Comparison of the Efficacy of Dry Needling, Ischemic Compression, and Cross Taping on Masseter Myofascial Pain

NCT06606041 | Active Not Recruiting

• 1 other identifier: FMUC-MD-PAIN
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn whether Dry Needling, Ischemic Compression, and Cross Tapes work to treat myofascial pain in masseter muscles in adults. It will also learn about the safety of this treatment. The main questions it aims to answer are:

• Do Dry Needling, Ischemic Compression, and Cross Tapes relieve masseter muscle pain?
• Which of these treatments provides the best relief from masseter muscle pain? Researchers will compare these three treatments to see which is best for treating masseter muscle pain. Participants will: Treated with Dry Needling or Ischemic Compression or Cross Tapes only once Visit the clinic one week, three months, and six months after treatment.

Conditions

Temporomandibular Joint Disorders; Myofascial Pain

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be assessed using the Numerical Pain Rating Scale, where 0 represents the absence of pain, and 10 describes the worst possible pain.

  At baseline, immediately after the intervention, 1 week, and 1 month after treatment

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Procedure: Dry Needling

Group 2

ACTIVE COMPARATOR

Procedure: Ischemic Compression

Group 3

ACTIVE COMPARATOR

Procedure: Cross Tapes

Interventions

Dry Needling PROCEDURE

This. minimally invasive technique is based on the insertion of a sterile, low-caliber, monofilament needle, without the injection or extraction of any additional substances, into hyperirritable muscle nodules. There are two categories within this technique, based on the depth at which the needle is inserted: superficial needling (or the Baldry technique), in which the needle is inserted up to the subcutaneous cellular tissue overlying the myofascial trigger point (up to 10 mm); and deep needling, where the needle is inserted into the muscle with the intention of reaching the myofascial trigger point. Reaching the trigger point was the investigators goal. Regardless of the technique selected, the aim is to generate controlled micro spasms in the affected muscle area, alternating with periods of muscle relaxation.

Group 1

Ischemic Compression PROCEDURE

Ischemic compression is a conservative, manual technique used on myofascial trigger points, in which pressure should be exerted between 30 and 90 seconds on these same areas. It is suggested that it leads to the normalization of the biomechanical properties of muscle fibers, restoring the muscle\'s functional condition and probably reducing the risk of injury. Thus, the therapeutic effects include the stimulation of mechanoreceptors, with pain attenuation mainly due to the depletion of specific neurotransmitters and temporary obstruction of local blood flow (local ischemia), followed by a rapid influx of oxygenated blood to the area under pressure relief,(37) which will cause an increase in muscle metabolism.

Group 2

Cross Tapes PROCEDURE

Cross tapes, as the name implies, based on an equidistant intersection of three or four polyester tapes with a non-elastic adhesive acrylic coating, with the 3 lines oriented in a latero-medial direction. It is recommended that it be applied to the muscle area where the myofascial trigger point has been detected, at a 45º angle to the muscle fibers. Its application may have several purposes, such as muscle support, improving the stability of the fibers; pain relief, especially in areas where muscle tension and/or inflammation are present; aiding lymphatic drainage; promoting blood circulation. Before it is applied, the skin should be clean (disinfecting the area with alcohol) and dry, without any lotion or other ointments and the maximum period of use should not exceed 24 hours due to the risk of changes in position, either due to sweating or direct intervention by the patient himself.

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with myofascial pain diagnosed according Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).

You may not qualify if:

• Pregnant women
• Other TMD-spectrum pathologies
• Anticoagulated and antiaggregated individuals
• Diabetes
• Blood disorders
• Fibromyalgia
• Autoimmune diseases in acute stages
• Neurological diseases
• Malignant tumor pathologies
• Patients with aichthyophobia
• Concomitant medication (opioids, antidepressants, myorelaxants)

Sponsors & Collaborators

• University of Coimbra: lead

Study Sites (2)

Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra

Coimbra, 3000-075, Portugal

Location

Faculty of Medicine of the University of Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Dry Needling; Acupressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Therapy, Soft Tissue; Musculoskeletal Manipulations; Rehabilitation

Study Officials

• Maria João Rodrigues, PhD

  Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicenter, Randomized parallel clinical trial comparing Dry Needling, Ischemic Compression, and Cross Tapes

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: January 10, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1); ES (1)