- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07921017
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Effects of Cervicothoracic Mobilization on Shoulder Pain, Range of Motion, and Disability in Patients With Supraspinatus Tendinitis
This study aims to evaluate the effects of cervicothoracic junction mobilization on pain, shoulder range of motion (ROM), and disability in patients with supraspinatus tendinitis. A randomized controlled trial will include 62 participants divided into experimental and control groups. The experimental group will receive cervicothoracic mobilization alongside conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed using NPRS, a goniometer, and SPADI. Data will be analyzed using IBM SPSS, with results reported after data collection and analysis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Supraspinatus tendinitis is a frequent cause of shoulder pain and functional impairment and may be influenced by dysfunction in the cervicothoracic region. Mobilization of the cervicothoracic junction has been suggested to improve shoulder symptoms by enhancing regional mobility and neuromuscular control; however, evidence in patients with supraspinatus tendinitis remains limited. This study will evaluate the effects of cervicothoracic junction mobilization on shoulder pain, range of motion (ROM), and disability in patients with supraspinatus tendinitis. A randomized controlled trial will be conducted with 62 participants diagnosed with supraspinatus tendinitis, recruited via convenience sampling after written informed consent. Participants will be randomly allocated into two groups (31each) using a computer-generated sequence by a blinded assistant, concealed in opaque envelopes. Group A (Experimental) will receive cervicothoracic mobilization (C6T4) using Maitland's Grade III-IV central PA and transverse oscillatory techniques, alongside conventional physiotherapy. Group B (Control) will receive conventional physiotherapy only, including moist heat (10 min), Codman's pendulum, stretching, scapular setting, and open-chain TheraBand resistance exercises. Outcomes-pain (NPRS), shoulder range of motion (goniometer), and disability (SPADI)-will be assessed at baseline and post-intervention. Data will be analyzed using an independent t-test in IBM SPSS, with significance set at p < 0.05. Will be given after Data Collection.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Imran Amjad, Phd
- Número de teléfono: 03324390125
- Correo electrónico: imran.amjad@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54700
- Reclutamiento
- Itefaq Hospital and PMC by Dr. Waqar Ali
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Contacto:
- Dr. Ali Raza, MS
- Número de teléfono: 03326099065
- Correo electrónico: dralirazapt@gmail.com
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Investigador principal:
- Zarish Fatima, MS OMPT
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Sub-Investigador:
- Ali Raza, MS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male and female patients both are included age ranging from 25 to 45 years.
- Diagnosis confirmed through Jobe's Test (Empty can) and characteristic signs and symptoms of supraspinatus tendinitis.
Exclusion Criteria:
- History of any previous surgical intervention involving the shoulder.
- Shoulder joint instability due to causes other than supraspinatus pathology.
- Presence of acromioclavicular joint arthritis.
- Participants were excluded if they had osteoporosis, spinal fractures, or tumors.
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: Cervicothoracic Junction Mobilization
This group will receive Maitland-based rhythmic oscillatory mobilizations, including central posterior-anterior and transverse techniques applied to the cervicothoracic region (C6-T4). |
Participants will receive Maitland-based rhythmic oscillatory mobilizations, including central posterior-anterior and transverse techniques applied to the cervicothoracic region (C6-T4), on every alternate day in addition to the same physiotherapy program provided to the control group over six weeks. |
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Comparador activo: Traditional physiotherapy
A standard physical therapy protocol is given to the participants in this group |
Cryotherapy for 10 minutes for the first 2 days. Codman exercises: 10 repetitions of each movement, 3 days/week, a strengthening protocol for the rotator cuff muscles and scapula. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: 4rth week
|
It is a scale to measure pain, where 0 indicates no pain, and 10 indicates the worst pain possible. |
4rth week
|
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Shoulder Pain And Disability Index (SPADI)
Periodo de tiempo: 4rth week
|
The Shoulder Pain and Disability Index (SPADI) is a self-reported questionnaire used to assess shoulder pain and disability in daily activities. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items), with higher scores indicating greater pain and functional limitation. |
4rth week
|
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ROM Shoulder (Abduction)
Periodo de tiempo: 4rth week
|
Changes from ROM of Shoulder Abduction were taken with the help of a goniometer |
4rth week
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ROM Shoulder (external rotation)
Periodo de tiempo: 4rth week
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Changes from ROM of Shoulder External rotation were taken with the help of a goniometer |
4rth week
|
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ROM shoulder (Flexion)
Periodo de tiempo: 4rth week
|
Changes from ROM of Shoulder Flexion were taken with the help of a goniometer |
4rth week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ali Raza, Mphill, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004 Sep 21;141(6):432-9. doi: 10.7326/0003-4819-141-6-200409210-00008.
- Vila-Dieguez O, Heindel MD, Awokuse D, Kulig K, Michener LA. Exercise for rotator cuff tendinopathy: Proposed mechanisms of recovery. Shoulder Elbow. 2023 Jun;15(3):233-249. doi: 10.1177/17585732231172166. Epub 2023 May 4.
- Liu S, Chen L, Shi Q, Fang Y, Da W, Xue C, Li X. Efficacy of manual therapy on shoulder pain and function in patients with rotator cuff injury: A systematic review and meta-analysis. Biomed Rep. 2024 Apr 11;20(6):89. doi: 10.3892/br.2024.1778. eCollection 2024 Jun.
- Spargoli G. SUPRASPINATUS TENDON PATHOMECHANICS: A CURRENT CONCEPTS REVIEW. Int J Sports Phys Ther. 2018 Dec;13(6):1083-1094.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR&AHS/25/0185
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.
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