- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07593781
rESWT vs LLLT for Cervical Myofascial Pain
May 16, 2026 updated by: Tirza Z Tamin, Indonesia University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Radial Extracorporeal Shockwave Therapy
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.
|
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.
Other Names:
|
|
Active Comparator: Low-Level Laser 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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 weeks
|
|
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
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Craniovertebral angle
Time Frame: 3 weeks
|
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.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tirza Z Tamin, MD, Indonesia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Actual)
August 30, 2025
Study Completion (Actual)
September 1, 2025
Study Registration Dates
First Submitted
May 12, 2026
First Submitted That Met QC Criteria
May 12, 2026
First Posted (Actual)
May 18, 2026
Study Record Updates
Last Update Posted (Actual)
May 19, 2026
Last Update Submitted That Met QC Criteria
May 16, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESWT vs LLLT in Cervical MPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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