NCT07593781

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

11 months

First QC Date

May 12, 2026

Last Update Submit

May 16, 2026

Conditions

Keywords

neck painextracorporeal shockwave therapylow-level light therapytrigger pointsmyofascial pain syndromes

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    3 weeks

Secondary Outcomes (1)

  • Craniovertebral angle

    3 weeks

Study Arms (2)

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.

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.

Device: Low-Level Laser Therapy

Interventions

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.

Also known as: rESWT, ESWT
Radial Extracorporeal Shockwave 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

Also known as: LLLT, photobiomodulation (PBM) therapy, Low-Level Light Therapy
Low-Level Laser Therapy

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitas Indonesia, Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesNeck Pain

Interventions

Low-Level Light TherapyTherapeutics

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyPhototherapy

Study Officials

  • Tirza Z Tamin, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 18, 2026

Study Start

October 1, 2024

Primary Completion

August 30, 2025

Study Completion

September 1, 2025

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations