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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Shoulder Function Assessed by Constant-Murley Score
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tulay Yildirim, MD, Inonu University Faculty of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUFM-PMR-2015-123
- 2015/123 (Otro identificador: Inonu University Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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