- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07766616
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mosab M Aldabbas, PhD
- Número de telefone: 00972597451222
- E-mail: mosab.m.aldabbas@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sleep Quality
Prazo: Pre and 8 weeks post intervention
|
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.
|
Pre and 8 weeks post intervention
|
|
Pain intensity
Prazo: Pre and 8 weeks post intervention
|
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.
|
Pre and 8 weeks post intervention
|
|
Disability
Prazo: Pre and 8 weeks post intervention
|
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.
|
Pre and 8 weeks post intervention
|
|
Stress
Prazo: pre and 8 weeks post intervention
|
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.
|
pre and 8 weeks post intervention
|
|
Pain Catastrophizing
Prazo: Pre and 8 weeks post intervention
|
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.
|
Pre and 8 weeks post intervention
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Al azhar AUG
- 000 (Outro identificador: CTGTY)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .