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NCT Number: NCT06606041

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pain intensity

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

    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.

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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