- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07593781
rESWT vs LLLT for Cervical Myofascial Pain
16. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Universitas Indonesia, Cipto Mangunkusumo General Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
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 navn:
|
|
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.
|
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity Changes (Numeric Rating Scale)
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Craniovertebral angle
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tirza Z Tamin, MD, Indonesia University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2024
Primær fullføring (Faktiske)
30. august 2025
Studiet fullført (Faktiske)
1. september 2025
Datoer for studieregistrering
Først innsendt
12. mai 2026
Først innsendt som oppfylte QC-kriteriene
12. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ESWT vs LLLT in Cervical MPS
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .