Temporomandibular Joint DisordersNCT06606041
Comparison of the Efficacy of Dry Needling, Ischemic Compression, and Cross Taping on Masseter Myofascial Pain
A study testing Dry Needling, Ischemic Compression and Cross Tapes in people with Temporomandibular Joint Disorders and Myofascial Pain, run by University of Coimbra at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Temporomandibular Joint Disorders, Myofascial Pain
- What is being tested?
- Dry Needling, Ischemic Compression and Cross Tapes
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with myofascial pain diagnosed according Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
Who cannot join
- Pregnant women
- Other TMD-spectrum pathologies
- Anticoagulated and antiaggregated individuals
- Diabetes
- Blood disorders
- Fibromyalgia
Show all 11Show fewer
- Autoimmune diseases in acute stages
- Neurological diseases
- Malignant tumor pathologies
- Patients with aichthyophobia
- Concomitant medication (opioids, antidepressants, myorelaxants)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Portugal1 site
Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra
Coimbra, 3000-075
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders, Myofascial Pain
- Being tested
- Dry Needling, Ischemic Compression, Cross Tapes
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
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 CompressionProcedure or surgery
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 TapesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Procedure: Dry Needling |
| Group 2 | Active comparator | Not described Receives: Procedure: Ischemic Compression |
| Group 3 | Active comparator | Not described Receives: Procedure: Cross Tapes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, immediately after the intervention, 1 week, and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Randomized parallel clinical trial comparing Dry Needling, Ischemic Compression, and Cross Tapes
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Macedo de Sousa, University of Coimbra
- Investigators
- Maria João Rodrigues, PhD, Study chair, Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606041
- Sponsor's protocol ID
- FMUC-MD-PAIN
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Dry Needling, Ischemic Compression, and Cross Taping on Masseter Myofascial Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06606041
- Acronym / sponsor ID
- FMUC-MD-PAIN
- Conditions
- Temporomandibular Joint Disorders, Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, Randomized parallel clinical trial comparing Dry Needling, Ischemic Compression, and Cross Tapes
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Dry Needling |
| Group 2 | Active comparator | Procedure: Ischemic Compression |
| Group 3 | Active comparator | Procedure: Cross Tapes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with myofascial pain diagnosed according Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
Key exclusion criteria (11 listed)
- Pregnant women
- Other TMD-spectrum pathologies
- Anticoagulated and antiaggregated individuals
- Diabetes
- Blood disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingThis. 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. | Procedure or surgery | Group 1 |
| Ischemic CompressionIschemic 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. | Procedure or surgery | Group 2 |
| Cross TapesCross 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. | Procedure or surgery | Group 3 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria João Rodrigues, PhD study chair
Faculty of Medicine, Institute of Occlusion and Orofacial Pain, University of Coimbra
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling, Ischemic Compression and Cross Tapes in people with Temporomandibular Joint Disorders and Myofascial Pain, run by University of Coimbra at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: At baseline, immediately after the intervention, 1 week, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.