- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07593781
rESWT vs LLLT for Cervical Myofascial Pain
16. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesien, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
Andre navne:
|
|
Aktiv komparator: 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.
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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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain Intensity Changes (Numeric Rating Scale)
Tidsramme: 3 weeks
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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
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3 weeks
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Cervical Range of Motion
Tidsramme: 3 weeks
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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
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3 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Craniovertebral angle
Tidsramme: 3 weeks
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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.
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3 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tirza Z Tamin, MD, Indonesia University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2024
Primær færdiggørelse (Faktiske)
30. august 2025
Studieafslutning (Faktiske)
1. september 2025
Datoer for studieregistrering
Først indsendt
12. maj 2026
Først indsendt, der opfyldte QC-kriterier
12. maj 2026
Først opslået (Faktiske)
18. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ESWT vs LLLT in Cervical MPS
Plan for individuelle deltagerdata (IPD)
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