Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Effects of Adding Acceptance and Commitment Therapy to Physiotherapy Program on Pain Catastrophizing, Stress, Disability, and Sleep Quality in Individuals With Chronic Low Back Pain
This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone.
A total of 60 participants will be randomly allocated into two groups: ACT plus physiotherapy and physiotherapy alone. Both groups will receive a 8-weeks program with two sessions per week. The ACT component focuses on acceptance, psychological flexibility, mindfulness, cognitive defusion, values, and committed action.
The main outcomes are pain catastrophizing, functional disability, perceived stress, and sleep quality, assessed using the PCS, ODI, PSS, and PSQI. The study aims to determine whether combining psychological and physical rehabilitation produces better outcomes than physiotherapy alone.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mosab M Aldabbas, PhD
- Número de teléfono: 00972597451222
- Correo electrónico: mosab.m.aldabbas@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
A_Aged between 18-55 years. B_Clinically diagnosed with non-specific chronic low back pain (CLBP). C_Low back pain persisting for more than 3 months.
Exclusion Criteria:
A. History of previous spinal surgeries or invasive interventions in the lumbar region.
B. Presence of "Red Flags" or serious underlying pathologies, such as spinal tumors, infections, or vertebral fractures.
C. Current or recent (within the last 6 months) participation in structured psychological rehabilitation or behavioral therapy programs.
D. Clinical evidence of neurological deficits, radiculopathy, or cauda equina syndrome.
E. Pregnancy, due to the physiological changes affecting musculoskeletal mechanics.
F. Severe behavioral or communication impairments preclude the ability to follow the intervention protocol or complete the self-report assessments.
G. Patients who take any sleep medication or for mental health medication. H. Patients who have done physiotherapy program last 3 months.
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 |
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Experimental: ACT + Physiotherapy
Participants will receive an integrated Acceptance and Commitment Therapy (ACT) and physiotherapy program for 8 weeks, with two sessions per week .
Each session will last approximately 45 minutes, including 15 minutes of ACT and 30 minutes of physiotherapy.
ACT will include acceptance, cognitive defusion, mindfulness, values clarification, and committed action.
Physiotherapy will include lumbar stabilization, core strengthening, aerobic conditioning, soft tissue techniques, and TENS.
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Participants in the experimental group will receive Acceptance and Commitment Therapy (ACT) as part of the integrated rehabilitation program.
ACT will be delivered for 15 minutes per session, twice weekly for 8 weeks .
The intervention will focus on functional acceptance, psychological flexibility, cognitive defusion, mindfulness and present-moment awareness, values clarification, and committed action.
The program aims to reduce pain catastrophizing and avoidance behaviors and promote engagement in meaningful activities despite chronic low back pain.
ACT will be followed by 30 minutes of physiotherapy during each session.
Participants will receive a standard physiotherapy program twice weekly for 8 weeks .
The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS.
The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain.
The same physiotherapy program will be provided to participants in both study arms.
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Comparador activo: Standard Physiotherapy
Participants will receive standard physiotherapy for 8 weeks, with two sessions per week .
The physiotherapy program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue techniques, and TENS.
Participants in this group will not receive Acceptance and Commitment Therapy or other ACT-based psychological interventions.
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Participants will receive a standard physiotherapy program twice weekly for 8 weeks .
The program will include lumbar stabilization exercises, core strengthening, flexibility and mobility exercises, aerobic conditioning, soft tissue release, and TENS.
The physiotherapy component aims to improve physical function, mobility, and functional ability in individuals with chronic low back pain.
The same physiotherapy program will be provided to participants in both study arms.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Sleep Quality
Periodo de tiempo: Pre and 8 weeks post intervention
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Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates several aspects of sleep during the previous month.
The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
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Pre and 8 weeks post intervention
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Pain intensity
Periodo de tiempo: Pre and 8 weeks post intervention
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VAS_Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Pre and 8 weeks post intervention
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Disability
Periodo de tiempo: Pre and 8 weeks post intervention
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Functional disability related to chronic low back pain will be assessed using the Oswestry Disability Index (ODI).
The questionnaire evaluates limitations in daily activities, with the total score expressed as a percentage.
Higher scores indicate greater disability.
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Pre and 8 weeks post intervention
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Stress
Periodo de tiempo: pre and 8 weeks post intervention
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Perceived stress will be assessed using the Perceived Stress Scale (PSS), which measures the extent to which situations in an individual's life are perceived as unpredictable, uncontrollable, and overwhelming.
Higher scores indicate greater perceived stress.
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pre and 8 weeks post intervention
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Pain Catastrophizing
Periodo de tiempo: Pre and 8 weeks post intervention
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Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS), which evaluates rumination, magnification, and helplessness related to pain.
Higher scores indicate greater pain catastrophizing.
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Pre and 8 weeks post intervention
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Más información
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Palabras clave
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Otros números de identificación del estudio
- Al azhar AUG
- 000 (Otro identificador: CTGTY)
Plan de datos de participantes individuales (IPD)
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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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