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Completed

NCT Number: NCT07593781

rESWT vs LLLT for Cervical Myofascial Pain

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.

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Key information

Conditions

Myofascial Pain Syndrome - Neck Extracorporeal Shockwave Therapy Low-Level Light Therapy Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigger Point Pain, Myofascial

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia, Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radial Extracorporeal Shockwave Therapy

Device

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: rESWT, ESWT

Low-Level Laser Therapy

Device

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: LLLT, photobiomodulation (PBM) therapy, Low-Level Light Therapy

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital

Registry information

Official study title

Radial Extracorporeal Shockwave Therapy vs Low-Level Laser Therapy for Cervical Myofascial Pain Syndrome in Adults: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 18, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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