Myofacial Pain SyndromeNCT07750392
Dry Needling and Low-Level Laser Microcurrent Electrical Stimulation for Myofascial Pain Syndrome
A study testing Dry Needle and Low-Level Laser Microcurrent Electrical Stimulation in people with Myofacial Pain Syndrome, run by Udayana University at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effectiveness of dry needling and Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) in patients with acute upper trapezius myofascial pain syndrome (MPS) by assessing both biological and clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Myofacial Pain Syndrome
- What is being tested?
- Dry Needle and Low-Level Laser Microcurrent Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Adults aged 20 to 45 years. Clinical diagnosis of acute upper trapezius myofascial pain syndrome (MPS) with symptom duration of less than 1 month.
- Presence of at least one active myofascial trigger point in the upper trapezius muscle confirmed by physical examination according to accepted diagnostic criteria (palpable taut band, hypersensitive trigger point, reproduction of the patient's typical pain, and/or local twitch response).
- Moderate or greater neck pain (Numerical Pain Rating Scale [NPRS] ≥4). Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Previous dry needling or LL MCES treatment for the current episode of myofascial pain.
- Chronic myofascial pain syndrome (symptom duration ≥1 month). Current use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications that may significantly influence inflammatory biomarkers within the washout period specified in the protocol.
- Previous surgery, fracture, or significant trauma involving the neck or shoulder region.
- Cervical radiculopathy, cervical myelopathy, fibromyalgia, inflammatory arthritis, or other neurological or musculoskeletal disorders that could explain the symptoms.
- Local skin infection, open wound, or other contraindications to dry needling or LL MCES.
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- Bleeding disorders, anticoagulant therapy, or other contraindications to needling.
- Pregnancy or breastfeeding. Active malignancy, autoimmune disease, uncontrolled diabetes mellitus, acute infection, or other systemic inflammatory conditions.
- History of severe psychiatric illness or inability to complete study assessments.
- Participation in another interventional clinical trial within the previous 30 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Udayana University
Denpasar, Bali
I Putu Eka Widyadharma, +62 812-3787-2840, eka.widyadharma@unud.ac.id
I Putu Eka Widyadharma, MD, PhD
About this study
Official title: The Role of Dry Needling Therapy and Low-Level Laser Microcurrent Electrical Stimulation on Serum Levels of Tumor Necrosis Factor-alpha (TNF-α) and Malondialdehyde (MDA) in Myofascial Pain Syndrome
This study aims to evaluate the effectiveness of dry needling and Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) in patients with acute upper trapezius myofascial pain syndrome (MPS) by assessing both biological and clinical outcomes. Specifically, it investigates whether these interventions reduce serum levels of the inflammatory biomarker tumor necrosis factor-alpha (TNF-α) and the oxidative stress biomarker malondialdehyde (MDA), while also improving pain intensity and neck-related disability. The study seeks to address the current knowledge gap regarding the relationship between changes in inflammatory and oxidative stress biomarkers and clinical improvement following these non-pharmacological treatments. The primary research question is: Do dry needling and LL MCES reduce serum TNF-α and MDA levels and improve clinical outcomes in patients with acute upper trapezius myofascial pain syndrome?
Participants will:
Read more
Be randomly assigned to receive dry needling, LL MCES, combined dry needling and LL MCES, or sham dry needling.
Receive treatment according to the assigned intervention protocol. Undergo blood sampling before and after the intervention to measure serum TNF-α and MDA levels.
Complete assessments of pain intensity using the Numerical Pain Rating Scale (NPRS) and neck-related disability using the Neck Disability Index (NDI) before and after treatment.
Attend scheduled follow-up visits for clinical evaluation and outcome assessment.
Read the detailed description
Myofascial pain syndrome (MPS) is a common musculoskeletal pain disorder characterized by the presence of myofascial trigger points within skeletal muscle, resulting in localized and referred pain, reduced range of motion, and functional impairment. Acute upper trapezius MPS is associated with activation of inflammatory pathways and oxidative stress, including increased production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and lipid peroxidation products such as malondialdehyde (MDA). These biological processes contribute to peripheral sensitization and may play an important role in the development and persistence of pain.
Dry needling is a minimally invasive intervention that targets myofascial trigger points through insertion of a solid filiform needle to elicit mechanical and neurophysiological responses. Proposed mechanisms include normalization of dysfunctional motor end plates, improvement of local blood flow, reduction of inflammatory mediators, and modulation of peripheral nociceptive input. Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) is a non-pharmacological modality that combines low-level laser therapy with microcurrent electrical stimulation to promote cellular repair, enhance adenosine triphosphate (ATP) production, improve tissue regeneration, and reduce inflammatory activity. Although both interventions have demonstrated clinical benefits in patients with MPS, evidence comparing their effects on systemic inflammatory and oxidative stress biomarkers remains limited.
This study is designed to investigate the biological mechanisms underlying the therapeutic effects of dry needling and LL MCES by evaluating changes in serum TNF-α and MDA concentrations following treatment. Clinical outcomes will be examined concurrently to explore whether biomarker modulation is associated with improvements in pain and functional disability. By integrating objective laboratory measures with patient-reported clinical outcomes, the study aims to provide insight into the pathophysiological mechanisms of treatment response in acute upper trapezius MPS.
The study will employ a prospective randomized controlled design involving adults with acute upper trapezius MPS. Participants will be allocated to one of four intervention groups: dry needling alone, LL MCES alone, combined dry needling and LL MCES, or sham dry needling. Serum TNF-α and MDA levels will be measured before and after the intervention, together with standardized assessments of pain intensity and neck-related disability. The findings are expected to clarify whether biomarker changes parallel clinical improvement and to provide evidence supporting mechanism-based, non-pharmacological management strategies for acute myofascial pain syndrome.
- Conditions
- Myofacial Pain Syndrome
- Being tested
- Dry Needle, Low-Level Laser Microcurrent Electrical Stimulation, Sham Dry Needle
- Keywords
- myofascial, dry needling, laser, tnf-alpha, Malondialdehyde
- Medical subject headings
- Facial Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedleDevice
Dry needling is performed using a sterile disposable filiform needle inserted into identified active trigger points of the upper trapezius muscle. The needle is manipulated to elicit a local twitch response when possible, and the procedure is conducted by a trained physician following a standardized treatment protocol.
Low-Level Laser Microcurrent Electrical StimulationDevice
Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) LL MCES is delivered using a therapeutic device that combines low-level laser irradiation and microcurrent electrical stimulation. Treatment parameters, application sites, and duration are standardized across participants.
Sham Dry NeedleDevice
A validated sham needling technique is used in which the procedure simulates dry needling while avoiding therapeutic penetration of the myofascial trigger point. The duration and treatment setting are matched to the active dry needling intervention.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling Group | Experimental | Participants receive dry needling treatment targeting active myofascial trigger points in the upper trapezius muscle according to the study protocol. Receives: Device: Dry Needle |
| Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) | Experimental | Participants receive LL MCES therapy applied to the upper trapezius trigger point region according to the study protocol. Receives: Device: Low-Level Laser Microcurrent Electrical Stimulation |
| Combined Dry Needling + LL MCES | Experimental | Participants receive both dry needling and LL MCES during the same treatment session according to the study protocol. Receives: Device: Dry Needle; Device: Low-Level Laser Microcurrent Electrical Stimulation |
| Sham Dry Needling | Sham comparator | Participants receive a sham dry needling procedure designed to mimic the treatment experience without therapeutic needle penetration of the trigger point. Receives: Device: Sham Dry Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Malondialdehyde (MDA) Concentration
Change in serum malondialdehyde (MDA) concentration from baseline to post-intervention measured using ELISA. Results will be expressed in nmol/mL. A greater reduction indicates improvement in oxidative stress.
Measured: Baseline and 3 days after completion of the intervention.
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Change in serum TNF-α concentration from baseline to post-intervention measured using enzyme-linked immunosorbent assay (ELISA). Results will be expressed in pg/mL. A greater reduction indicates improvement in systemic inflammatory activity.
Measured: Baseline and 3 days after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start30 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofacial Pain SyndromeStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I Putu Eka Widyadharma, MD, MSc, PhD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750392
- Sponsor's protocol ID
- 2632/UN14.2.2.VII.14/LT/2026
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No additional information is required.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dry Needling Therapy and Low-Level Laser Microcurrent Electrical Stimulation on Serum Levels of Tumor Necrosis Factor-alpha (TNF-α) and Malondialdehyde (MDA) in Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07750392
- Acronym / sponsor ID
- 2632/UN14.2.2.VII.14/LT/2026
- Conditions
- Myofacial Pain Syndrome
- Keywords
- myofascial, dry needling, laser, tnf-alpha, Malondialdehyde
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
This study aims to evaluate the effectiveness of dry needling and Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) in patients with acute upper trapezius myofascial pain syndrome (MPS) by assessing both biological and clinical outcomes. Specifically, it investigates whether these interventions reduce serum levels of the inflammatory biomarker tumor necrosis factor-alpha (TNF-α) and the oxidative stress biomarker malondialdehyde (MDA), while also improving pain intensity and neck-related disability. The study seeks to address the current knowledge gap regarding the relationship between changes in inflammatory and oxidative stress biomarkers and clinical improvement following these non-pharmacological treatments. The primary research question is: Do dry needling and LL MCES reduce serum TNF-α and MDA levels and improve clinical outcomes in patients with acute upper trapezius myofascial pain syndrome?
Participants will:
Be randomly assigned to receive dry needling, LL MCES, combined dry needling and LL MCES, or sham dry needling.
Receive treatment according to the assigned intervention protocol. Undergo blood sampling before and after the intervention to measure serum TNF-α and MDA levels.
Complete assessments of pain intensity using the Numerical Pain Rating Scale (NPRS) and neck-related disability using the Neck Disability Index (NDI) before and after treatment.
Attend scheduled follow-up visits for clinical evaluation and outcome assessment.
Detailed description
Myofascial pain syndrome (MPS) is a common musculoskeletal pain disorder characterized by the presence of myofascial trigger points within skeletal muscle, resulting in localized and referred pain, reduced range of motion, and functional impairment. Acute upper trapezius MPS is associated with activation of inflammatory pathways and oxidative stress, including increased production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and lipid peroxidation products such as malondialdehyde (MDA). These biological processes contribute to peripheral sensitization and may play an important role in the development and persistence of pain.
Dry needling is a minimally invasive intervention that targets myofascial trigger points through insertion of a solid filiform needle to elicit mechanical and neurophysiological responses. Proposed mechanisms include normalization of dysfunctional motor end plates, improvement of local blood flow, reduction of inflammatory mediators, and modulation of peripheral nociceptive input. Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) is a non-pharmacological modality that combines low-level laser therapy with microcurrent electrical stimulation to promote cellular repair, enhance adenosine triphosphate (ATP) production, improve tissue regeneration, and reduce inflammatory activity. Although both interventions have demonstrated clinical benefits in patients with MPS, evidence comparing their effects on systemic inflammatory and oxidative stress biomarkers remains limited.
This study is designed to investigate the biological mechanisms underlying the therapeutic effects of dry needling and LL MCES by evaluating changes in serum TNF-α and MDA concentrations following treatment. Clinical outcomes will be examined concurrently to explore whether biomarker modulation is associated with improvements in pain and functional disability. By integrating objective laboratory measures with patient-reported clinical outcomes, the study aims to provide insight into the pathophysiological mechanisms of treatment response in acute upper trapezius MPS.
The study will employ a prospective randomized controlled design involving adults with acute upper trapezius MPS. Participants will be allocated to one of four intervention groups: dry needling alone, LL MCES alone, combined dry needling and LL MCES, or sham dry needling. Serum TNF-α and MDA levels will be measured before and after the intervention, together with standardized assessments of pain intensity and neck-related disability. The findings are expected to clarify whether biomarker changes parallel clinical improvement and to provide evidence supporting mechanism-based, non-pharmacological management strategies for acute myofascial pain syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dry Needling Group | Experimental | Device: Dry NeedleParticipants receive dry needling treatment targeting active myofascial trigger points in the upper trapezius muscle according to the study protocol. |
| Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) | Experimental | Device: Low-Level Laser Microcurrent Electrical StimulationParticipants receive LL MCES therapy applied to the upper trapezius trigger point region according to the study protocol. |
| Combined Dry Needling + LL MCES | Experimental | Device: Dry Needle, Device: Low-Level Laser Microcurrent Electrical StimulationParticipants receive both dry needling and LL MCES during the same treatment session according to the study protocol. |
| Sham Dry Needling | Sham comparator | Device: Sham Dry NeedleParticipants receive a sham dry needling procedure designed to mimic the treatment experience without therapeutic needle penetration of the trigger point. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must meet all of the following criteria:
- Adults aged 20 to 45 years. Clinical diagnosis of acute upper trapezius myofascial pain syndrome (MPS) with symptom duration of less than 1 month.
- Presence of at least one active myofascial trigger point in the upper trapezius muscle confirmed by physical examination according to accepted diagnostic criteria (palpable taut band, hypersensitive trigger point, reproduction of the patient's typical pain, and/or local twitch response).
- Moderate or greater neck pain (Numerical Pain Rating Scale [NPRS] ≥4). Willing and able to provide written informed consent and comply with study procedures.
Key exclusion criteria (10 listed)
- Participants meeting any of the following criteria will be excluded:
- Previous dry needling or LL MCES treatment for the current episode of myofascial pain.
- Chronic myofascial pain syndrome (symptom duration ≥1 month). Current use of systemic corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications that may significantly influence inflammatory biomarkers within the washout period specified in the protocol.
- Previous surgery, fracture, or significant trauma involving the neck or shoulder region.
- Cervical radiculopathy, cervical myelopathy, fibromyalgia, inflammatory arthritis, or other neurological or musculoskeletal disorders that could explain the symptoms.
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 NeedleDry needling is performed using a sterile disposable filiform needle inserted into identified active trigger points of the upper trapezius muscle. The needle is manipulated to elicit a local twitch response when possible, and the procedure is conducted by a trained physician following a standardized treatment protocol. | Device | Combined Dry Needling + LL MCES, Dry Needling Group |
| Low-Level Laser Microcurrent Electrical StimulationLow-Level Laser Microcurrent Electrical Stimulation (LL MCES) LL MCES is delivered using a therapeutic device that combines low-level laser irradiation and microcurrent electrical stimulation. Treatment parameters, application sites, and duration are standardized across participants. | Device | Combined Dry Needling + LL MCES, Low-Level Laser Microcurrent Electrical Stimulation (LL MCES) |
| Sham Dry NeedleA validated sham needling technique is used in which the procedure simulates dry needling while avoiding therapeutic penetration of the myofascial trigger point. The duration and treatment setting are matched to the active dry needling intervention. | Device | Sham Dry Needling |
Primary outcome
Change in Serum Malondialdehyde (MDA) Concentration
Time frame: Baseline and 3 days after completion of the intervention.
Change in serum malondialdehyde (MDA) concentration from baseline to post-intervention measured using ELISA. Results will be expressed in nmol/mL. A greater reduction indicates improvement in oxidative stress.
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α) Concentration
Time frame: Baseline and 3 days after completion of the intervention.
Change in serum TNF-α concentration from baseline to post-intervention measured using enzyme-linked immunosorbent assay (ELISA). Results will be expressed in pg/mL. A greater reduction indicates improvement in systemic inflammatory activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. No additional information is required.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needle and Low-Level Laser Microcurrent Electrical Stimulation in people with Myofacial Pain Syndrome, run by Udayana University at 1 site in Indonesia.
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 10 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I Putu Eka Widyadharma, MD, PhD (+62 812-3787-2840, eka.widyadharma@unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Malondialdehyde (MDA) Concentration (time frame: Baseline and 3 days after completion of the intervention.). The study lists 2 primary outcomes in all. 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 10 Aug 2026.