- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07604168
Effect of Coordinated Locomotor Training on Lumbopelvic Stability and Pain in Runners With Mechanical Low Back Pain (CLT-LBP-RUN)
Effect of Coordinated Locomotor Training on Lumbopelvic Stability and Pain Limitations in Runners With Mechanical Low Back Pain: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Mechanical low back pain is one of the most common musculoskeletal conditions affecting individuals globally. Lumbopelvic instability is linked to persistent pain and dysfunction in individuals with low back pain. During running, an anterior pelvic tilt is associated with an increased degree of lumbar lordosis, creating mechanical stress from repetitive loading. This stress can lead to running-related low back pain and other overuse symptoms. Novice runners are particularly vulnerable due to poor lumbopelvic control, altered biomechanics, and weak core stability.
Coordinated Locomotor Training is a neuromotor exercise approach designed to enhance synchronization of upper and lower limb movements while promoting activation of trunk and abdominal musculature. By stimulating contraction of abdominal muscles through upper and lower extremity motions in various postures, Coordinated Locomotor Training has been shown to improve postural control. However, there is limited research on the use of Coordinated Locomotor Training in novice runners, particularly for improving lumbopelvic stability and reducing pain limitations.
Study Design: This is a randomized controlled trial with double blinding (participants and outcome assessors will be blinded to group assignment). The study will be conducted at three university settings in Faisalabad, Pakistan: The University of Faisalabad, Government College University of Faisalabad, and Agriculture University of Faisalabad.
Participant Screening: Potential participants will be screened against inclusion and exclusion criteria. Inclusion criteria include age 18 to 30 years, novice runner status (less than one year of consistent running experience), history of mechanical low back pain for 6 to 12 weeks (sub-acute phase), pain intensity between 4 and 6 on the Numeric Pain Rating Scale, running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 kilometers, pain aggravated by mechanical activities such as running, lifting, and prolonged standing and relieved by rest, and willingness to provide written informed consent. Exclusion criteria include participation in any structured core training or rehabilitation program within the past 3 months, history of spinal surgery or specific spinal pathology such as disc herniation or spondylolisthesis, presence of pain radiating below the knee or neurological symptoms including numbness, tingling, or weakness, current lower limb injury affecting running performance, severe pain intensity greater than 6 on the Numeric Pain Rating Scale, pregnancy or postpartum period within the last 6 months, and unwillingness to participate.
Randomization: Participants will be randomly assigned to one of two groups using a computer-generated random sequence. Allocation concealment will be maintained using sealed opaque envelopes.
Group A Intervention (Coordinated Locomotor Training): Participants will perform a 5-minute warm-up to familiarize with sprinter and skater techniques actively performed in a standing position. The main Coordinated Locomotor Training session lasts 60 minutes, given twice per week for 8 weeks (16 total sessions). Participants will perform coordinated movement training in four positions: supine, crawling, sitting, and standing. In each position, participants perform 10 repetitions per set, completing 3 sets total for approximately 30 minutes of active training. The sprinter pattern involves alternating arm and leg movements mimicking running form. The skater pattern involves lateral weight shifts with coordinated arm and leg opposition.
Group B Intervention (Plyometric Training): The warm-up consists of two sets of 30-second stimulation sessions followed by a 30-second cool-down with multidirectional hops spaced up to five seconds apart. Participants then perform six series of squat jumps with 30 seconds of activation and 30 seconds of relaxation between series. Each jump uses a 45 cm box height, with a two-second gap between each jump within each series. Total session time is 60 minutes, twice per week for 8 weeks.
Outcome Measurements: All outcome measures will be assessed at baseline (week 0) and post-intervention (week 8). The primary outcome is pain, measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain). The secondary outcome is lumbopelvic stability, measured using two tools. First, a handmade pelvic inclinometer measures anterior pelvic tilt by placing caliper tips on the anterior superior iliac spine and posterior superior iliac spine of the ilium, then reading the angle from the protractor scale. Second, a flexible curve ruler measures lumbar lordosis by molding a flexible piece of lead to fit the spine from T12 to S2, tracing the shape onto paper, and calculating lordosis from the curvature length and maximum width.
Data Analysis: Data will be analyzed using SPSS version 22. Descriptive statistics will be calculated for baseline characteristics. Normality of data distribution will be assessed using the Shapiro-Wilk test. For normally distributed data, between-group comparisons will be performed using independent t-tests, and within-group comparisons will be performed using paired t-tests. For non-normally distributed data, Mann-Whitney U tests will be used for between-group comparisons and Wilcoxon signed-rank tests for within-group comparisons. Statistical significance will be set at p < 0.05.
Ethical Considerations: Ethical approval has been obtained from the Institutional Review Board of The University of Faisalabad. Written informed consent will be obtained from all participants prior to enrollment. Participants will be informed of their right to withdraw from the study at any time without penalty. Confidentiality of all participant data will be maintained. The study will be conducted in accordance with the Declaration of Helsinki.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Punjab Province
-
Faisalābad, Punjab Province, Pakistán, 3800
- The University of Faisalabad
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age between 18 and 30 years
- Novice runner with less than one year of consistent running experience
- History of mechanical low back pain for 6 to 12 weeks (sub-acute phase)
- Pain intensity between 4 and 6 on the Numeric Pain Rating Scale
- Running frequency of 2 to 4 sessions per week with total weekly mileage less than 25 km
- Pain aggravated by mechanical activities (running, lifting, prolonged standing) and relieved by rest
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Participation in any structured core training or rehabilitation program within the past 3 months
- History of spinal surgery or specific spinal pathology (disc herniation, spondylolisthesis)
- Presence of pain radiating below the knee or neurological symptoms (numbness, tingling, weakness)
- Current lower limb injury affecting running performance
- Severe pain intensity greater than 6 on the Numeric Pain Rating Scale
- Pregnancy or postpartum period within the last 6 months in females
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: Coordinated Locomotor Training Group
Participants receive Coordinated Locomotor Training consisting of sprinter and skater pattern exercises performed in supine, crawling, sitting, and standing positions.
Each session lasts 60 minutes, twice weekly for 8 weeks.
|
Coordinated Locomotor Training is a neuromotor exercise program that enhances synchronization of upper and lower limb movements while promoting trunk muscle activation.
The protocol includes sprinter and skater pattern exercises performed in four positions: supine, crawling, sitting, and standing.
Participants perform 10 repetitions per set, completing 3 sets per session.
Each session includes a 5-minute warm-up followed by 30 minutes of active training, totaling 60 minutes per session.
The intervention is delivered twice weekly for 8 weeks (16 sessions total) by a trained physical therapist.
|
|
Comparador activo: Plyometric Training Group
Participants receive plyometric training consisting of squat jumps and multidirectional hops using a 45 cm box.
Each session lasts 60 minutes, twice weekly for 8 weeks.
|
Plyometric training consists of explosive jump exercises designed to improve power and neuromuscular control.
The protocol includes two sets of 30-second stimulation sessions with multidirectional hops, followed by six series of squat jumps using a 45 cm box height.
Each series includes 30 seconds of activation and 30 seconds of relaxation, with a two-second gap between each jump.
Total session time is 60 minutes, delivered twice weekly for 8 weeks (16 sessions total).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pain Intensity
Periodo de tiempo: Baseline (week 0) and post-intervention (week 8)
|
Pain intensity will be measured using the Numeric Pain Rating Scale, an 11-point scale from 0 (no pain) to 10 (worst possible pain).
Participants rate their current low back pain and their worst pain over the past 24 hours.
The scale has excellent test-retest reliability (r > 0.90) and high sensitivity to clinical change.
|
Baseline (week 0) and post-intervention (week 8)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Lumbopelvic Stability - Anterior Pelvic Tilt
Periodo de tiempo: Baseline (week 0) and post-intervention (week 8)
|
Anterior pelvic tilt in degrees will be measured using a handmade pelvic inclinometer.
The examiner places one caliper tip on the anterior superior iliac spine and the other tip on the posterior superior iliac spine of the same ilium.
The angle in degrees is read from the protractor scale.
A greater angle indicates increased anterior pelvic tilt.
|
Baseline (week 0) and post-intervention (week 8)
|
|
Change in Lumbopelvic Stability - Lumbar Lordosis Angle
Periodo de tiempo: Baseline (week 0) and post-intervention (week 8)
|
Lumbar lordosis angle (°) will be measured using a flexible curve ruler.
The ruler will be molded to fit the lumbar spine from T12 to S2, then removed and traced onto paper.
The total length of the curvature (L, cm) and the maximum width or depth of the curvature (H, cm) will be measured.
The lumbar lordosis angle will then be calculated and expressed in degrees (°) using the standard flexible ruler formula.
|
Baseline (week 0) and post-intervention (week 8)
|
Colaboradores e Investigadores
Patrocinador
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
- Dolor
- Manifestaciones neurológicas
- Dolor de espalda
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Lumbalgia
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Ejercicio pliométrico
Otros números de identificación del estudio
- TUF/EIRB/ 209 /26
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. .