- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07702604
Effect of a Comprehensive Corrective Exercise Program With and Without Instrument-Assisted Soft Tissue Mobilization on Cervical Range of Motion, Muscle Strength, Disability, and Postural Alignment in Individuals With Upper-Crossed Syndrome
This study is a double-blind, parallel-group randomized controlled trial designed to evaluate the effectiveness of a Comprehensive Corrective Exercise Program (CCEP) with and without Instrument-Assisted Soft Tissue Mobilization (IASTM) in individuals with Upper-Crossed Syndrome (UCS). UCS is a common postural dysfunction characterized by muscular imbalance, including tightness of the upper trapezius, levator scapulae, and pectoral muscles, along with weakness of the deep cervical flexors and scapular stabilizers. This imbalance leads to forward head posture, rounded shoulders, neck pain, reduced cervical mobility, and functional limitations, particularly in individuals exposed to prolonged sedentary activities and poor ergonomic conditions.
A total of 60 participants aged 18-40 years diagnosed with Upper-Crossed Syndrome will be recruited and randomly allocated into two groups. The control group will receive a structured Comprehensive Corrective Exercise Program (CCEP), while the experimental group will receive the same exercise program combined with Instrument-Assisted Soft Tissue Mobilization (IASTM).
Both interventions will be administered three times per week for six weeks under the supervision of a trained physiotherapist. Outcome measures will be assessed at baseline and after completion of the intervention period. Primary outcomes include cervical range of motion, muscle strength assessed by the Deep Neck Flexor endurance test, functional disability measured using the Neck Disability Index, and postural alignment assessed using a plumb line method.
The aim of this study is to determine whether the addition of IASTM to a corrective exercise program results in superior improvements in cervical mobility, muscle strength, functional disability, and postural alignment compared to corrective exercise alone. It is hypothesized that the combined intervention will produce greater clinical improvements in individuals with Upper-Crossed Syndrome.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Upper-Crossed Syndrome (UCS) is a commonly observed postural dysfunction characterized by a predictable pattern of muscular imbalance involving tightness of the upper trapezius, levator scapulae, and pectoral muscles, along with weakness of the deep cervical flexors, lower trapezius, and serratus anterior. This imbalance alters normal cervical-thoracic alignment, resulting in forward head posture, rounded shoulders, and increased thoracic kyphosis. These postural deviations are frequently associated with neck pain, reduced cervical range of motion, impaired neuromuscular control, and decreased functional performance.
The prevalence of UCS has increased significantly due to modern lifestyle factors such as prolonged screen exposure, sedentary work environments, and poor ergonomic habits. Individuals including students, office workers, and healthcare professionals are particularly vulnerable. UCS is now recognized as a multidimensional condition involving biomechanical, neuromuscular, and sensorimotor dysfunction rather than a purely structural disorder.
Corrective exercise programs are widely regarded as the cornerstone of UCS management. These programs aim to restore muscular balance by stretching shortened muscles and strengthening inhibited muscles, thereby improving posture, alignment, and functional outcomes. Evidence from randomized controlled trials demonstrates that structured corrective exercise programs can significantly improve forward head posture, scapular alignment, muscle activation, and functional performance.
Instrument-Assisted Soft Tissue Mobilization (IASTM) has emerged as an effective adjunctive intervention in musculoskeletal rehabilitation. IASTM is believed to improve soft tissue mobility, reduce fascial adhesions, enhance local circulation, and facilitate neuromuscular activation. Previous studies have shown that IASTM can lead to reductions in pain, improvements in cervical range of motion, and enhanced functional outcomes in individuals with chronic neck pain and related conditions.
Despite evidence supporting both corrective exercise programs and IASTM independently, limited research has evaluated their combined effects specifically in individuals with Upper-Crossed Syndrome. Existing studies have often used general physiotherapy protocols without incorporating structured Comprehensive Corrective Exercise Programs tailored to UCS. Therefore, it remains unclear whether the integration of IASTM with a targeted corrective exercise program provides superior outcomes compared to exercise alone.
This study aims to address this gap by evaluating the effectiveness of combining IASTM with a Comprehensive Corrective Exercise Program (CCEP) in individuals with UCS. The study will be conducted as a double-blind randomized controlled trial at the Department of Physiotherapy and Rehabilitation, Ghurki Trust Teaching Hospital.
A total of 60 participants aged 18-40 years meeting the inclusion criteria will be recruited using a non-probability convenience sampling technique. Participants will be screened for eligibility and those meeting the criteria will be randomly allocated into two groups using a computer-generated randomization sequence. Allocation concealment will be ensured using sealed, opaque, sequentially numbered envelopes.
The control group (Group A) will receive a Comprehensive Corrective Exercise Program (CCEP), which includes stretching of overactive muscles, strengthening of weak muscles, and postural re-education exercises. The experimental group (Group B) will receive the same exercise program combined with Instrument-Assisted Soft Tissue Mobilization (IASTM).
Each intervention session will last approximately 40 minutes and will be conducted three times per week for six consecutive weeks, resulting in a total of 18 sessions. The exercise program will include therapist-assisted stretching of muscles such as the pectoralis major and minor, upper trapezius, levator scapulae, and sternocleidomastoid. Strengthening exercises will target deep cervical flexors, lower trapezius, rhomboids, and serratus anterior. Postural re-education and motor control exercises will be included to improve cervical and scapular alignment.
In the experimental group, IASTM will be applied to overactive muscles using standardized tools and techniques, including scanning, sweeping, and fanning. Each muscle group will be treated for a specified duration, followed by stretching to enhance tissue extensibility and reduce muscle tone.
Outcome measures will be assessed at baseline and after completion of the six-week intervention period by a blinded assessor. Cervical range of motion will be measured using a goniometer. Muscle strength and endurance will be assessed using the Deep Neck Flexor endurance test. Functional disability will be evaluated using the Neck Disability Index (NDI), and postural alignment will be assessed using a plumb line method.
Data analysis will be performed using SPSS software. Descriptive statistics will summarize demographic characteristics and baseline data. Normality of data distribution will be assessed using the Shapiro-Wilk test. Based on the results, appropriate parametric or non-parametric tests will be used. Between-group comparisons will be conducted using independent samples t-tests or Mann-Whitney U tests, while within-group comparisons will be performed using paired t-tests or Wilcoxon signed-rank tests.
Ethical considerations will be strictly followed throughout the study. Participants will provide informed consent prior to participation. Confidentiality of participant data will be maintained, and participants will have the right to withdraw from the study at any time without consequences. Any adverse events will be monitored and documented.
This study is expected to provide evidence regarding the effectiveness of combining Instrument-Assisted Soft Tissue Mobilization with a Comprehensive Corrective Exercise Program in improving cervical range of motion, muscle strength, functional disability, and postural alignment in individuals with Upper-Crossed Syndrome. The findings may contribute to improved clinical decision-making and the development of more effective rehabilitation strategies for postural dysfunctions.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Maryam Nadeem, DPT, MSPT
- Número de teléfono: +92 334 4010121
- Correo electrónico: maryamnadeem1321@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Aroona Sattar, DPT, MSPT
- Número de teléfono: +92 305 4630138
- Correo electrónico: aroona.sattar@ubas.edu.pk
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán, 53400
- Ghurki Trust Teaching Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18-40 years
- Both males and females
- Diagnosed with Upper-Crossed Syndrome
- Presence of forward head posture and rounded shoulders
- Chronic neck pain related to postural dysfunction
Exclusion Criteria:
- History of cervical spine surgery or fracture
- Neurological conditions (e.g., radiculopathy, myelopathy)
- Systemic musculoskeletal disorders (e.g., rheumatoid arthritis)
- Current physiotherapy treatment for neck pain
- Skin conditions preventing IASTM application
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CCEP with Instrument-Assisted Soft Tissue Mobilization (IASTM)
Participants in this arm will receive the same Comprehensive Corrective Exercise Program (CCEP) as the control group, combined with Instrument-Assisted Soft Tissue Mobilization (IASTM).
IASTM will be applied to overactive muscles including upper trapezius, levator scapulae, sternocleidomastoid, and pectoral muscles using standardized techniques (scanning, sweeping, and fanning).
Each session will last approximately 20 minutes and will be performed three times per week for six weeks under physiotherapist supervision.
|
This intervention combines the Comprehensive Corrective Exercise Program (CCEP) with Instrument-Assisted Soft Tissue Mobilization (IASTM).
The exercise component is identical to the control group and includes stretching, strengthening, and postural re-education exercises targeting cervical and scapular musculature.
IASTM is applied to overactive muscles including upper trapezius, levator scapulae, sternocleidomastoid, and pectoral muscles using specialized instruments with techniques such as scanning, sweeping, J-stroke, and fanning.
Each session lasts approximately 20 minutes, administered three times per week for six weeks under physiotherapist supervision.
|
|
Comparador activo: Comprehensive Corrective Exercise Program (CCEP)
Participants in this arm will receive a Comprehensive Corrective Exercise Program (CCEP) only.
The program includes stretching of overactive muscles (pectoralis major/minor, upper trapezius, levator scapulae, sternocleidomastoid), strengthening of weak muscles (deep cervical flexors, lower trapezius, rhomboids, serratus anterior), and postural re-education and motor control exercises.
Sessions will be supervised by a physiotherapist, conducted three times per week for six weeks.
|
The Comprehensive Corrective Exercise Program (CCEP) is a structured physiotherapy intervention designed to correct muscular imbalance associated with Upper-Crossed Syndrome.
It includes stretching of overactive muscles (pectoralis major and minor, upper trapezius, levator scapulae, sternocleidomastoid), strengthening of weak muscles (deep cervical flexors, lower trapezius, rhomboids, serratus anterior), and motor control and postural re-education exercises.
Exercises are performed under physiotherapist supervision three times per week for six weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cervical Range of Motion (CROM)
Periodo de tiempo: Baseline and 6 weeks
|
Cervical range of motion will be measured using a goniometer.
Measurements will include flexion, extension, lateral flexion, and rotation.
|
Baseline and 6 weeks
|
|
Postural Alignment
Periodo de tiempo: Baseline and 6 weeks
|
Postural alignment will be assessed using a plumb line method to evaluate forward head posture and rounded shoulder posture.
|
Baseline and 6 weeks
|
|
Muscle Strength (Deep Neck Flexor Endurance Test)
Periodo de tiempo: Baseline and 6 weeks
|
The Deep Neck Flexor Endurance Test (also known as the craniocervical flexion endurance test) measures the duration a participant can hold a chin-tuck position with correct form.
Scores range from 0 to 60 seconds, with the test terminated at 60 seconds if the position is maintained that long.
Higher scores indicate better deep neck flexor muscle endurance.
|
Baseline and 6 weeks
|
|
Neck Disability (Neck Disability Index)
Periodo de tiempo: Baseline and 6 weeks
|
The Neck Disability Index is a 10-item patient-reported outcome measure assessing functional disability related to neck pain, covering activities such as personal care, lifting, reading, and concentration.
Each item is scored 0-5, for a total score range of 0 to 50.
Higher scores indicate greater disability.
|
Baseline and 6 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Shoaib Waqas, PhD, Lahore University of Biological and Applied Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UBAS/ERB/26/04/018
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. .