Myofascial Pain Syndrome - NeckNCT07593781
rESWT vs LLLT for Cervical Myofascial Pain
A study testing Radial Extracorporeal Shockwave Therapy and Low-Level Laser Therapy in people with Myofascial Pain Syndrome - Neck and Extracorporeal Shockwave Therapy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Background and Aim: Myofascial pain syndrome (MPS) in the cervical region is one of the most common musculoskeletal disorders associated with myofascial trigger points that cause muscle pain, stiffness, and reduced range of motion, precipitated by forward head posture. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Myofascial Pain Syndrome - Neck, Extracorporeal Shockwave Therapy, Low-Level Light Therapy
- What is being tested?
- Radial Extracorporeal Shockwave Therapy and Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2024to 1 Sep 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women
- aged 18 to 59 years old
- sedentary activity level
- active MTrP on the upper trapezius muscle
- moderate pain with an NRS pain score of 4-7
- restriction of ROM
- CVA angle of ≤ 50°
- All agreed to participate in this study with informed consent.
Who cannot join
- patients who were unable to complete the assessment or communicate adequately based on the Indonesian version of Montreal Cognitive Assessment (MoCA-Ina)
- experiencing neck pain caused by radicular syndrome proven with the Spurling test, distraction test and Adson test.
- history of malignancy
- history of blood clotting disorder
- receiving anticoagulant therapy
- in a emergency state (e.g., loss of consciousness, shortness of breath, active bleeding, seizures, or hyperpyrexia)
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- pregnant
- participants with pacemaker
- participants undergoing other treatments (manual therapy, massage, acupuncture, dry needling, or other rehabilitation modalities) for neck pain in the previous two weeks
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia, Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Radial Extracorporeal Shockwave Therapy vs Low-Level Laser Therapy for Cervical Myofascial Pain Syndrome in Adults: A Randomized Controlled Trial
Background and Aim: Myofascial pain syndrome (MPS) in the cervical region is one of the most common musculoskeletal disorders associated with myofascial trigger points that cause muscle pain, stiffness, and reduced range of motion, precipitated by forward head posture. Many non-invasive modalities, including low-level laser therapy (LLLT) and extracorporeal shockwave therapy (ESWT), have been reported to reduce symptoms. However, comparative effectiveness of these interventions remains unclear. This study aimed to compare the effectiveness of radial ESWT and LLLT in reducing pain and improving functional outcomes in patients with cervical MPS among the working-age adults. Methods: A randomized controlled study was conducted in a working-age adults with MPS. Fifty subjects, divided in two groups received either ESWT or LLLT. Numeric rating scale (NRS), cervical range of motion (ROM), and craniovertebral angle (CVA) were assessed before and throughout three weeks post intervention. Results: Both LLLT and ESWT showed significant (p < 0.001) changes in NRS, cervical ROM, and CVA. LLLT showed a difference in pain reduction at week three (p < 0.001) and flexion and extension ROM at week two and three (p < 0.05). Conclusion: LLLT demonstrated superior results in pain reduction at the three-week mark and produced greater increases in cervical flexion and extension ROM during the two- and three-week periods when compared with ESWT.
- Conditions
- Myofascial Pain Syndrome - Neck, Extracorporeal Shockwave Therapy, Low-Level Light Therapy, Trigger Point Pain, Myofascial
- Being tested
- Radial Extracorporeal Shockwave Therapy, Low-Level Laser Therapy
- Keywords
- neck pain, extracorporeal shockwave therapy, low-level light therapy, trigger points, myofascial pain syndromes
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shockwave TherapyDevice
Also called rESWT, ESWT
The first group intervened with ESWT BTL-5000 SWR radial 2000-4000 pulse per session, once a week, for a duration of 10-60 minutes, for three weeks. ESWT was applied to MTrPs bilaterally at 2.5 bar, with a frequency of up to 10 Hz and an energy flux density of 0.05-0.35 mJ/mm². Ultrasound gel was applied to the skin where ESWT probes were attached.
Low-Level Laser TherapyDevice
Also called LLLT, photobiomodulation (PBM) therapy, Low-Level Light Therapy
The second group received LLLT with BTL 4000 a total of six times, given twice a week. LLLT was applied to palpated active MTrPs at a dose of 40-50 J and an average power of 100 mW
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shockwave Therapy | Active comparator | The first group intervened with ESWT BTL-5000 SWR radial 2000-4000 pulse per session, once a week, for a duration of 10-60 minutes, for three weeks. ESWT was applied to MTrPs bilaterally at 2.5 bar, with a frequency of up to 10 Hz and an energy flux density of 0.05-0.35 mJ/mm². Ultrasound gel was applied to the skin where ESWT probes were attached. Receives: Device: Radial Extracorporeal Shockwave Therapy |
| Low-Level Laser Therapy | Active comparator | The second group received LLLT with BTL 4000 a total of six times, given twice a week. LLLT was applied to palpated active MTrPs at a dose of 40-50 J and an average power of 100 mW. Receives: Device: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Changes (Numeric Rating Scale)
NRS is an instrument to evaluate pain subjectively, with 11 scores of pain, ranging from 0 "no pain" to 10 "worst pain possible." Pain intensity categorized into mild (0-3), moderate (4-6), and severe (>7). Participants must be fully conscious, mentally competent, and able to communicate verbally. MCID in the NRS score is 1.3.21
Measured: 3 weeks
Cervical Range of Motion
Cervical ROM was used to detect movement dysfunction on patients' necks. Limitation of ROM can be caused by pain, muscle shortening, and other structural problems. ROM was measured with a goniometer.22 Patients were positioned to measure neck flexion, extension, lateral bending, and rotation. The examiner then measured the angle formed. Normal ranges are 1) flexion: 45.9-46.8°, 2) extension: 42.7-47.4°, 3) rotation to right: 63.3-67.2°, 4) rotation to left: 65.7-67.8°, 5) lateral flexion to right: 31.5-34.9°, and 6) lateral flexion to left: 31.4-36.6°.23
Measured: 3 weeks
Secondary outcomes (1)
Craniovertebral angle
CVA is defined as the angle between a horizontal line passing through the C7 spinous process and a line connecting C7 to the tragus. A smaller CVA indicates greater anterior head displacement and increases the risk of forward head posture. The normal value is > 50°, while forward head posture has a CVA of < 50°. Outcome analysis was conducted based on the change from baseline values, evaluated at baseline, in Weeks 1, 2, and 3 after treatment.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Oct 2024
- Primary completion30 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - NeckStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Principal investigator, Tirza Z Tamin, Universitas Indonesia
- Investigators
- Tirza Z Tamin, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593781
- Sponsor's protocol ID
- ESWT vs LLLT in Cervical MPS
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Extracorporeal Shockwave Therapy vs Low-Level Laser Therapy for Cervical Myofascial Pain Syndrome in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07593781
- Acronym / sponsor ID
- ESWT vs LLLT in Cervical MPS
- Conditions
- Myofascial Pain Syndrome - Neck, Extracorporeal Shockwave Therapy, Low-Level Light Therapy, Trigger Point Pain, Myofascial
- Keywords
- neck pain, extracorporeal shockwave therapy, low-level light therapy, trigger points, myofascial pain syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 18 May 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.
Background and Aim: Myofascial pain syndrome (MPS) in the cervical region is one of the most common musculoskeletal disorders associated with myofascial trigger points that cause muscle pain, stiffness, and reduced range of motion, precipitated by forward head posture. Many non-invasive modalities, including low-level laser therapy (LLLT) and extracorporeal shockwave therapy (ESWT), have been reported to reduce symptoms. However, comparative effectiveness of these interventions remains unclear. This study aimed to compare the effectiveness of radial ESWT and LLLT in reducing pain and improving functional outcomes in patients with cervical MPS among the working-age adults. Methods: A randomized controlled study was conducted in a working-age adults with MPS. Fifty subjects, divided in two groups received either ESWT or LLLT. Numeric rating scale (NRS), cervical range of motion (ROM), and craniovertebral angle (CVA) were assessed before and throughout three weeks post intervention. Results: Both LLLT and ESWT showed significant (p < 0.001) changes in NRS, cervical ROM, and CVA. LLLT showed a difference in pain reduction at week three (p < 0.001) and flexion and extension ROM at week two and three (p < 0.05). Conclusion: LLLT demonstrated superior results in pain reduction at the three-week mark and produced greater increases in cervical flexion and extension ROM during the two- and three-week periods when compared with ESWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shockwave Therapy | Active comparator | Device: Radial Extracorporeal Shockwave TherapyThe first group intervened with ESWT BTL-5000 SWR radial 2000-4000 pulse per session, once a week, for a duration of 10-60 minutes, for three weeks. ESWT was applied to MTrPs bilaterally at 2.5 bar, with a frequency of up to 10 Hz and an energy flux density of 0.05-0.35 mJ/mm². Ultrasound gel was applied to the skin where ESWT probes were attached. |
| Low-Level Laser Therapy | Active comparator | Device: Low-Level Laser TherapyThe second group received LLLT with BTL 4000 a total of six times, given twice a week. LLLT was applied to palpated active MTrPs at a dose of 40-50 J and an average power of 100 mW. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- men and women
- aged 18 to 59 years old
- sedentary activity level
- active MTrP on the upper trapezius muscle
- moderate pain with an NRS pain score of 4-7
Key exclusion criteria (9 listed)
- patients who were unable to complete the assessment or communicate adequately based on the Indonesian version of Montreal Cognitive Assessment (MoCA-Ina)
- experiencing neck pain caused by radicular syndrome proven with the Spurling test, distraction test and Adson test.
- history of malignancy
- history of blood clotting disorder
- receiving anticoagulant therapy
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 |
|---|---|---|
| Radial Extracorporeal Shockwave TherapyAlso: rESWT, ESWTThe first group intervened with ESWT BTL-5000 SWR radial 2000-4000 pulse per session, once a week, for a duration of 10-60 minutes, for three weeks. ESWT was applied to MTrPs bilaterally at 2.5 bar, with a frequency of up to 10 Hz and an energy flux density of 0.05-0.35 mJ/mm². Ultrasound gel was applied to the skin where ESWT probes were attached. | Device | Radial Extracorporeal Shockwave Therapy |
| Low-Level Laser TherapyAlso: LLLT, photobiomodulation (PBM) therapy, Low-Level Light TherapyThe second group received LLLT with BTL 4000 a total of six times, given twice a week. LLLT was applied to palpated active MTrPs at a dose of 40-50 J and an average power of 100 mW | Device | Low-Level Laser Therapy |
Primary outcome
Pain Intensity Changes (Numeric Rating Scale)
Time frame: 3 weeks
NRS is an instrument to evaluate pain subjectively, with 11 scores of pain, ranging from 0 "no pain" to 10 "worst pain possible." Pain intensity categorized into mild (0-3), moderate (4-6), and severe (>7). Participants must be fully conscious, mentally competent, and able to communicate verbally. MCID in the NRS score is 1.3.21
Cervical Range of Motion
Time frame: 3 weeks
Cervical ROM was used to detect movement dysfunction on patients' necks. Limitation of ROM can be caused by pain, muscle shortening, and other structural problems. ROM was measured with a goniometer.22 Patients were positioned to measure neck flexion, extension, lateral bending, and rotation. The examiner then measured the angle formed. Normal ranges are 1) flexion: 45.9-46.8°, 2) extension: 42.7-47.4°, 3) rotation to right: 63.3-67.2°, 4) rotation to left: 65.7-67.8°, 5) lateral flexion to right: 31.5-34.9°, and 6) lateral flexion to left: 31.4-36.6°.23
1 secondary outcome
Craniovertebral angle
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- 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.
Tirza Z Tamin, MD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shockwave Therapy and Low-Level Laser Therapy in people with Myofascial Pain Syndrome - Neck and Extracorporeal Shockwave Therapy, run by Universitas Indonesia 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 19 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Changes (Numeric Rating Scale) (time frame: 3 weeks). 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 19 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.