Myofascial Pain - Dysfunction Syndrome of TMJNCT06583915
Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Myofascial Pain Dysfunction Syndrome
A study testing TENS and Dry Needle in people with Myofascial Pain - Dysfunction Syndrome of TMJ, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Myofascial Pain - Dysfunction Syndrome of TMJ
- What is being tested?
- TENS and Dry Needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Aug 2025
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Patient with Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: a Randomized Clinical Trial
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.
Read the detailed description
Myofascial pain syndrome (MPS) is a prevalent affliction among individuals experiencing musculoskeletal pain issues. This condition is characterized by pain originating from the muscle and surrounding fascia. Patients typically exhibit localized pain in a confined region or referred pain with diverse patterns.
Additionally, physical examinations may reveal trigger points on the affected muscles. MPS can be categorized into acute and chronic forms. Acute MPS often resolves spontaneously or with uncomplicated treatments. However, chronic MPS typically has a poorer prognosis, and symptoms may persist for six months or more.
Dry needling involves the insertion of a solid filiform needle into a trigger point without the administration of any substance. Various theories have been put forth to explain the mechanisms by which dry needling alleviates pain . These include the \"gate control\" theory, modulation of endogenous opioids such as B-endorphin, encephalins, and dynorphins, disruption of central sensitization through activation of Aβ fibers resulting in inhibition of synaptic transmission between Aβ and C fibers and cells of the spinal cord dorsal horn due to their slower impulse conduction, and even placebo effects have been suggested . When a needle is inserted into a trigger point, it may elicit a local twitch response. This reflexive contraction of the trigger point can also facilitate physiological changes, including the reduction of spontaneous electrical activity and the concentration of inflammatory and nociceptive chemicals, ultimately resulting in the relaxation of the trigger point.
Transcutaneous electrical nerve stimulation (TENS) is considered to be a highly secure and cost-effective modality for managing both chronic and acute pain. As per the gate control theory, TENS employs low voltage electrical pulses that are applied to the central nervous system. The modulation of pain perception induced by TENS is attributed to the recruitment of Aβ afferent fibers in the posterior horn of the spinal cord, which prevents the activation of pain conducted in thin fiber. Electrical stimulation effectively inhibits the transmission of painful impulses through the spinal cord and stimulates the release of endogenous opioids by the brain. Its safe, noninvasive, inexpensive and effective method of providing analgesia with reduced potential adverse effects compared to other treatment modalities.
In this research, we aim to evaluate TENS is a suitable treatment for MPDS patients, which would eliminate the need for another treatment modality. The expected benefit in this study is to find the best treatment for MPDS reducing pain, muscle stiffness and limited mouth opening.
- Being tested
- TENS, Dry Needle
- 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.
TENSProcedure or surgery
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.
Dry NeedleProcedure or surgery
Invasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation | Experimental | Low voltage electrical pulses that are applied to the central nervous system Receives: Procedure: TENS |
| Dry Needling | Active comparator | insertion of a solid filiform needle into a trigger point without the administration of any substance Receives: Procedure: Dry Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Using visual analogue scale (VAS) from (1-10) where 1 is the least pain and 10 is the maximum pain
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (5)
Muscle stiffness
using Electromyography to measure muscle response or electrical activity in response to a nerve stimulation of the muscle (volt)
Measured: From enrollment to the end of treatment at 6 months
Limitation in mouth openinig
Measuring muscle opening using digital caliber (Micrometer)
Measured: From enrollment to the end of treatment at 6 months
Sleeping disorder
Assessing sleeping disorder through Yes or No questionnaire
Measured: From enrollment to the end of treatment at 6 months
Anxiety
Assessing anxiety through Yes or No questionnaire
Measured: From enrollment to the end of treatment at 6 months
Patient satisfaction
Assessing patient satisfaction through Yes or No questionnaire
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Dec 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain - Dysfunction Syndrome of TMJStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amina amr sayed mohamed salama, Cairo University
- Investigators
- Mostafa ElGengehy, PhD, Study chair, Professor, Department of oral and maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583915
- Sponsor's protocol ID
- OMFS333
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: lack of research ethics committee approval of secondary use of IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Dry Needling Vs Transcutaneous Electrical Nerve Stimulation in Management of Patient with Myofascial Pain Dysfunction Syndrome Using Electromyography and Visual Analogue Scale: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06583915
- Acronym / sponsor ID
- OMFS333
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 4 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.
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.
Detailed description
Myofascial pain syndrome (MPS) is a prevalent affliction among individuals experiencing musculoskeletal pain issues. This condition is characterized by pain originating from the muscle and surrounding fascia. Patients typically exhibit localized pain in a confined region or referred pain with diverse patterns.
Additionally, physical examinations may reveal trigger points on the affected muscles. MPS can be categorized into acute and chronic forms. Acute MPS often resolves spontaneously or with uncomplicated treatments. However, chronic MPS typically has a poorer prognosis, and symptoms may persist for six months or more.
Dry needling involves the insertion of a solid filiform needle into a trigger point without the administration of any substance. Various theories have been put forth to explain the mechanisms by which dry needling alleviates pain . These include the \"gate control\" theory, modulation of endogenous opioids such as B-endorphin, encephalins, and dynorphins, disruption of central sensitization through activation of Aβ fibers resulting in inhibition of synaptic transmission between Aβ and C fibers and cells of the spinal cord dorsal horn due to their slower impulse conduction, and even placebo effects have been suggested . When a needle is inserted into a trigger point, it may elicit a local twitch response. This reflexive contraction of the trigger point can also facilitate physiological changes, including the reduction of spontaneous electrical activity and the concentration of inflammatory and nociceptive chemicals, ultimately resulting in the relaxation of the trigger point.
Transcutaneous electrical nerve stimulation (TENS) is considered to be a highly secure and cost-effective modality for managing both chronic and acute pain. As per the gate control theory, TENS employs low voltage electrical pulses that are applied to the central nervous system. The modulation of pain perception induced by TENS is attributed to the recruitment of Aβ afferent fibers in the posterior horn of the spinal cord, which prevents the activation of pain conducted in thin fiber. Electrical stimulation effectively inhibits the transmission of painful impulses through the spinal cord and stimulates the release of endogenous opioids by the brain. Its safe, noninvasive, inexpensive and effective method of providing analgesia with reduced potential adverse effects compared to other treatment modalities.
In this research, we aim to evaluate TENS is a suitable treatment for MPDS patients, which would eliminate the need for another treatment modality. The expected benefit in this study is to find the best treatment for MPDS reducing pain, muscle stiffness and limited mouth opening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation | Experimental | Procedure: TENSLow voltage electrical pulses that are applied to the central nervous system |
| Dry Needling | Active comparator | Procedure: Dry Needleinsertion of a solid filiform needle into a trigger point without the administration of any substance |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| TENSNon-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. | Procedure or surgery | Transcutaneous electrical nerve stimulation |
| Dry NeedleInvasive procedure where a fine needle or acupuncture needle is inserted into the skin and muscle. | Procedure or surgery | Dry Needling |
Primary outcome
Pain
Time frame: From enrollment to the end of treatment at 6 months
Using visual analogue scale (VAS) from (1-10) where 1 is the least pain and 10 is the maximum pain
5 secondary outcomes
Muscle stiffness
Time frame: From enrollment to the end of treatment at 6 months
Limitation in mouth openinig
Time frame: From enrollment to the end of treatment at 6 months
Sleeping disorder
Time frame: From enrollment to the end of treatment at 6 months
Anxiety
Time frame: From enrollment to the end of treatment at 6 months
Patient satisfaction
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No. lack of research ethics committee approval of secondary use of IPD
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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.
Mostafa ElGengehy, PhD study chair
Professor, Department of oral and maxillofacial surgery
Questions about this trial
What is this clinical trial studying?
A study testing TENS and Dry Needle in people with Myofascial Pain - Dysfunction Syndrome of TMJ, run by Cairo University.
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 4 inclusion and 7 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mostafa ElGengehy, PhD (+201221089223, mostafa.elgengehe@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: From enrollment to the end of treatment at 6 months). 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 4 Sep 2024.