- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07586800
High-Intensity Laser Therapy Versus Multimodal Physiotherapy in Subacromial Impingement Syndrome
Short-Term Effects of High-Intensity Laser Therapy Compared With Multimodal Physiotherapy in Subacromial Impingement Syndrome: A Randomized Controlled Trial
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Subacromial impingement syndrome (SIS) is one of the most common causes of shoulder pain and functional limitation. Conservative treatment strategies, particularly exercise-based rehabilitation, are recommended as first-line therapy. High-intensity laser therapy (HILT) has recently gained attention because of its potential analgesic and anti-inflammatory effects; however, its comparative effectiveness against multimodal physiotherapy remains unclear.
This single-centre, assessor-blinded randomized controlled trial was conducted at the Department of Physical Medicine and Rehabilitation, Inonu University Hospital, Malatya, Türkiye. Adults aged 18-65 years with clinically and radiologically confirmed SIS were enrolled. Participants were allocated to either a high-intensity laser therapy group or a combined conventional physiotherapy group. Both groups additionally participated in an identical supervised exercise program.
The HILT group received class IV Nd:YAG laser therapy (1064 nm), whereas the control group received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. Treatment duration was three weeks.
The primary outcome measure was pain intensity assessed using the visual analogue scale (VAS). Secondary outcomes included the Constant-Murley Score, Shoulder Pain and Disability Index (SPADI), and Short Form-36 quality-of-life assessment. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.
The study was approved by the Inonu University Clinical Research Ethics Committee (Approval No: 2015/123). The trial was retrospectively submitted for registration at ClinicalTrials.gov.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:Inclusion Criteria:
- Adults aged 18 to 65 years
- Clinically and radiologically confirmed subacromial impingement syndrome
- Shoulder pain lasting at least 1 month and less than 6 months
- At least one positive impingement test (Neer, Hawkins-Kennedy, painful arc, or Jobe test)
- MRI findings consistent with stage I-II rotator cuff changes
Exclusion Criteria:
- Previous shoulder surgery or trauma
- Inflammatory rheumatic disease
- Recent myocardial infarction
- Active infection
- Previous physiotherapy or corticosteroid injection within the last 6 months
- Pregnancy
- Calcific tendinitis
- Adhesive capsulitis
- Cervical radiculopathy
- Neurological disorders affecting the shoulder
- Full-thickness rotator cuff tear
- Contraindications to electrotherapy or laser therapy
Exclusion Criteria:
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: High-Intensity Laser Therapy
Participants received class IV Nd:YAG high-intensity laser therapy three times weekly for three weeks in addition to a supervised exercise program.
|
Class IV Nd:YAG laser therapy (1064 nm wavelength) administered to the shoulder region for treatment of subacromial impingement syndrome.
|
|
Aktiv komparator: Multimodal Physiotherapy
Participants received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound combined with a supervised exercise program.
|
Combined physiotherapy program consisting of hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS)
Tidsramme: Baseline, 3 weeks, and 7 weeks
|
Pain intensity at rest, during movement, and at night assessed using a 10-cm visual analogue scale.
|
Baseline, 3 weeks, and 7 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder Function Assessed by Constant-Murley Score
Tidsramme: Baseline, 3 weeks, and 7 weeks
|
Shoulder functional status assessed using the Constant-Murley Score.
|
Baseline, 3 weeks, and 7 weeks
|
|
Shoulder Disability Assessed by SPADI
Tidsramme: Baseline, 3 weeks, and 7 weeks
|
Shoulder Pain and Disability Index (SPADI) used to assess disability related to shoulder pain.
|
Baseline, 3 weeks, and 7 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Tulay Yildirim, MD, Inonu University Faculty of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IUFM-PMR-2015-123
- 2015/123 (Anden identifikator: Inonu University Clinical Research Ethics Committee)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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