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- Ensayo clínico NCT07724665
Effects Of Scapulothoracic Intervention With Or Without Neural Mobilization In Patients With Cervico-Brachialgia
Effects Of Scapulothoracic Intervention With Or Without Neural Mobilization On Pain, Function, And Neural Mechano-Sensitivity In Patients With Cervico Brachialgia
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The aim of the study is to determine the effects of scapulothoracic intervention with or without neural mobilization on pain, function, and neural mechanosensitivity in patients with cervicobrachialgia.
Methods: A randomized controlled trial will be conducted on 40 patients diagnosed with cervicobrachialgia. Participants will be randomly allocated into two groups, with 20 participants in each group. Group A received scapulothoracic rehabilitation combined with neural mobilization (ST+NM), while Group B received neural mobilization alone (NM). Treatment will be administered according to the study protocol over the intervention period. Outcome measures includes the Numeric Pain Rating Scale (NPRS) for pain intensity, Neck Pain Questionnaire (NPQ) for neck-related disability, PainDETECT Questionnaire (PDQ) for neuropathic pain symptoms, and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire for upper limb function. Assessments were performed before and after the intervention. Data will be analyzed using paired sample t-tests, independent sample t-tests, Mann-Whitney U tests, and Wilcoxon Signed Rank tests with a significance level of p<0.05.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sumrod Akram
- Número de teléfono: 03324806143
- Correo electrónico: samrood.akram@riphah.edu.pk
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Cervicobrachial pain
- Females and males
- Aged 30-50 years
- Able to communicate and follow the instructions
- Able to perform cervical exercises according to cervicogenic pain
Exclusion Criteria:
- Negative neurodynamic test
- Neck and upper extremity surgery
- Vertebral instability
- Vertebral spine infection
- Neurological disease of genetic, infection, or neuroplastic origin
- Inflammatory or systemic disease
- VBI symptoms
- Rheumatoid arthritis
- Subjects with presence of any fractures.
- Heart/diabetic patient
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: Scapulothoracic intervention with Neural Mobilization
Group A received Scapulothoracic intervention with Neural Mobilization
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Neural Mobilization: Pain-free tension
|
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Comparador activo: Neural Mobilization
Group B received Neural Mobilization alone.
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Neural Mobilization: Pain-free tension
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analogue Scale (VAS)
Periodo de tiempo: upto 6 weeks
|
The VAS is a common, subjective measurement tool that is used to measure the level of pain severity using an 11-point range with zero (no pain) and ten (heaviest pain imaginable).
Patients use a subjective scale to rate their pain verbally and the following scales apply to 1-3 mild, 4-6 moderate, and 7-10 severe pain.
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upto 6 weeks
|
|
Northwick Park Neck Pain Questionnaire (NPQ)
Periodo de tiempo: upto 6 weeks
|
The NPQ is a 9- questionnaire assessing neck pain disability with each question put on a scale of 0 to 4(code converted to percentage).
It examines nocturnal sleep, activities during the day, and social goals.
With cervicobrachialgia, it is used to measure functional restrictiveness such as neck/arm pain.
Scores: 0-20 percent (light), 21-40 percent (moderate), >40 percent (severe).
|
upto 6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PainDETECT questionnaire (PD-Q)
Periodo de tiempo: upto 6 weeks
|
It is a 9-item instrument that has 7 scored items 0-5, and 2 items of the pain pattern characteristics of neuropathic pain in cervicobrachialgia.
score 0-38: <13 (not likely neuropathic), 13-18 (indeterminate), >=19 (probable neuropathic).
It assesses the quality of pain (burning, tingling etc.), radiation patterns.
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upto 6 weeks
|
|
Disability of Arm, Shoulder and Hand (DASH)
Periodo de tiempo: upto 6 weeks
|
The DASH assesses upper limb disability and is a 30 item questionnaire scaled 1-5.
The total point (0-100) is counted: [(the sum of the responses/n) -1] x 25.
The higher the score and the more they are disabled.
The course is minimal clinically significant difference, 10 points.
In case of cervicobrachialgia, it examines the impairment of arm functioning.
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upto 6 weeks
|
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FABF Questionnaire (FABQ)
Periodo de tiempo: upto 6 weeks
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FABQ contains 16 items consisting of two subscales namely, physical activity (4 items, 0-24) and work (7 items, 0-42).
The more the score, the higher fear-avoidance.
In cervicobrachialgia, scores above 14 (work) or 12 (physical activity), predict an unsatisfactory recovery.
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upto 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ramish Safraz, Riphah International University
Publicaciones y enlaces útiles
Publicaciones Generales
- Wagner FM. [Somatic dysfunction of the cervical spine and its complex clinical picture : The fundamentals of diagnostics of cervicobrachialgia and cervicocephalic syndrome through manual medicine]. Orthopade. 2022 Apr;51(4):263-273. doi: 10.1007/s00132-022-04228-7. Epub 2022 Mar 3. German.
- Sanchez AC, Requena JBS, Pantaleaon LAL, Esqueda ATI, Raidi VMV, Gallardo IR, et al. # 36401 Post-traumatic compressive C6 cervicobrachialgia, not all that glitters is gold. BMJ Publishing Group Ltd; 2023.
- Kerimova EK, Isaikin AI, Romanova AS, Bashlachev MG, Mouki K. Cervicalgia and cervicobrachialgia in periarticular cyst at the cervical level. Case report. Consilium Medicum. 2025;27(02):94-8.
- Thomson S, Ainsworth G, Selvanathan S, Brown S, Croft J, Kelly R, Mujica-Mota R, Rousseau N, Higham R, Stocken D. Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial). Br J Neurosurg. 2024 Feb;38(1):141-148. doi: 10.1080/02688697.2023.2267119. Epub 2024 Jan 27.
- Fujastawan IGV. Management of Physiotherapy in Case of Brachialgia Due to Cervical Spondyloarthrosis. Science Midwifery. 2022;10(2):755-8.
- Rani A, Chopra J, Singh RR, Bajpai PK. Prevalence of various anomalies of costal element at cervico-thoracic junction in and around lucknow region of uttarpradesh: A radiological study. Biomed Res. 2021;32(1):7-14.
- AHMED AA, SHABAN M. Conservative Treatment of Cervical Discs without Myelopathy: A Three Years Follow-up. The Medical Journal of Cairo University. 2023;91(03):403-7.
- Thomson S, Ainsworth G, Selvanathan S, Kelly R, Collier H, Mujica-Mota R, Talbot R, Brown ST, Croft J, Rousseau N, Higham R, Al-Tamimi Y, Buxton N, Carleton-Bland N, Gledhill M, Halstead V, Hutchinson P, Meacock J, Mukerji N, Pal D, Vargas-Palacios A, Prasad A, Wilby M, Stocken D. Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT. Health Technol Assess. 2023 Oct;27(21):1-228. doi: 10.3310/OTOH7720.
- Korman DV, Yushmanov IG. The influence of osteopathic correction to the level of stress in patients with cervicobrachialgia. Российский остеопатический. 2020:56.
- Ilić J, Kostić A, Ilić M, Nikolov V, Stojanović N, Todorović S. Cervicobrachial syndrome: Prevalence and clinical correlation with coronavirus 2019 disease among hospitalized patients. Acta Medica Medianae. 2024;63(3).
Fechas de registro del estudio
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Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR & AHS/25/0141
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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