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

Comparison of the Efficacy of Dry Needling, Ischemic Compression, and Cross Taping on Masseter Myofascial Pain: A Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myofascial Pain; Temporomandibular Joint Disorders
• Intervention / Treatment: Procedure: Dry Needling; Procedure: Ischemic Compression; Procedure: Cross Tapes

Detailed Description

The taut band represents the most commonly observed muscular disorder, where myofascial trigger points may arise, causing referred pain in another location. Therapeutic strategies applied for its treatment include dry needling, ischemic compression, and cross-taping.

Objectives: To compare the effectiveness of these treatment methods in reducing or alleviating the intensity of pain in the masseter.

In this multicenter randomized clinical trial, the study sample underwent a clinical examination according to the Diagnostic Criteria for Temporomandibular Disorders to diagnose the presence of orofacial myofascial pain with taut bands in the masseter. Participants were randomly allocated to three groups based on the treatment methods.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-075
    • Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra
• Spain
  • Salamanca, Spain, 37007
    • Faculty of Medicine of the University of Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1	Procedure: Dry Needling; 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.
Active Comparator: Group 2	Procedure: Ischemic Compression; 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.
Active Comparator: Group 3	Procedure: Cross Tapes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Coimbra
• Investigators: Study Chair: Maria João Rodrigues, PhD, Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: FMUC-MD-PAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No