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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07672028
ERGON Therapy and Muscle Energy Technique for Mechanical Neck Pain (ERGOMET)
Comparison of ERGON Therapy With and Without Muscle Energy Technique in Patients With Mechanical Neck Pain: A Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Mechanical neck pain is a common musculoskeletal condition that can adversely affect daily activities, work productivity, and quality of life. Various manual therapy approaches have been used to manage neck pain, including Instrument-Assisted Soft Tissue Mobilization (IASTM) techniques such as ERGON Therapy and Muscle Energy Technique (MET). However, limited evidence exists regarding the comparative effectiveness of ERGON Therapy with and without MET in individuals with mechanical neck pain.
This randomized clinical trial will recruit 42 participants diagnosed with mechanical neck pain. Eligible participants will be randomly allocated into two groups. Group A will receive ERGON Therapy in combination with Muscle Energy Technique, while Group B will receive ERGON Therapy alone. In addition, both groups will receive a standardized conventional physiotherapy program consisting of TENS, hot pack application, and cervical stretching exercises.
The intervention period will be conducted according to a predefined treatment protocol. Outcome measures will include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), cervical range of motion measured using appropriate clinical tools, and functional disability assessed using the Neck Disability Index (NDI). Assessments will be performed at baseline and after completion of the intervention period.
The primary objective of the study will be to determine whether the addition of Muscle Energy Technique to ERGON Therapy provides superior improvements in pain reduction, cervical mobility, and functional disability compared with ERGON Therapy alone. The results of this trial are expected to contribute to evidence-based rehabilitation strategies for the management of mechanical neck pain.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sialkot, Pakistán, 54910
- Bethania Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Individuals clinically diagnosed with mechanical neck pain Duration of neck pain of at least 2 weeks Willingness to participate and provide written informed consent
Exclusion Criteria:
History of cervical spine surgery within the past 12 months History of trauma or infection in the cervical region Presence of neurological deficits or cervical radiculopathy Presence of systemic disorders affecting musculoskeletal function Any other musculoskeletal deformity or significant disability affecting the neck region
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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 |
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Experimental: Experimental Group
ERGON Therapy combined with Muscle Energy Technique plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
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Participants in the experimental group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique combined with Muscle Energy Technique.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
Muscle Energy Technique will be used to facilitate joint mobility and reduce muscular tightness.
In addition, participants will receive conventional physiotherapy including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
Otros nombres:
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Comparador activo: Comparator Group
ERGON Therapy alone plus conventional physiotherapy including TENS, hot pack application, and cervical stretching exercises.
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Participants in the comparator group will receive Instrument-Assisted Soft Tissue Mobilization using ERGON technique alone.
ERGON therapy will be applied to cervical soft tissues to improve tissue mobility and reduce pain.
In addition, participants will receive the same conventional physiotherapy protocol including Transcutaneous Electrical Nerve Stimulation (TENS), hot pack application, and cervical stretching exercises.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pain Intensity (NPRS)
Periodo de tiempo: Baseline and after completion of 6 treatment sessions (2 weeks)
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Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates worst possible pain.
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Baseline and after completion of 6 treatment sessions (2 weeks)
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Cervical Range of Motion (CROM)
Periodo de tiempo: Baseline and after completion of 6 treatment sessions over 2 weeks
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Cervical range of motion refers to the measurement of movement of the cervical spine in different planes, including flexion, extension, lateral flexion, and rotation.
It reflects neck mobility and functional joint movement and will be assessed using standard clinical methods at baseline and post-intervention.
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Baseline and after completion of 6 treatment sessions over 2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Disability (Neck Disability Index - NDI)
Periodo de tiempo: Baseline and after completion of 6 treatment sessions over 2 weeks
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Functional disability related to mechanical neck pain will be assessed using the Neck Disability Index (NDI).
The questionnaire measures the impact of neck pain on activities of daily living, including personal care, lifting, reading, work, and concentration.
Higher scores indicate greater disability.
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Baseline and after completion of 6 treatment sessions over 2 weeks
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: DANYAL AHMAD, University of Management and Technology Sialkot Pakistan
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- kuhs/dpt/umt-skt-028
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
De-identified individual participant data including baseline characteristics (age, gender), pain scores (Numeric Pain Rating Scale), cervical range of motion measurements, and Neck Disability Index scores will be shared. No personally identifiable information such as names, contact numbers, or hospital identification numbers will be included.
Supporting study documents such as study protocol and data collection forms may also be made available.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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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