- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07621302
Mindfulness-Based Therapy for Chronic Low Back Pain in Office Workers
The Effect of Mindfulness-Based Therapies on Pain Severity in Office Workers With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
This study evaluated whether a mindfulness-based therapy program could reduce pain severity in office workers with non-specific chronic low back pain.
The study included staff members of Dokuz Eylul University aged 20 to 59 years who had low back pain for at least three months and worked at a desk for more than four hours per day. Participants were randomly assigned to either a mindfulness-based therapy group or a control group.
The mindfulness-based therapy group attended online group sessions once a week for four weeks. The sessions included breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices. Participants in the control group continued their usual medical care during the study period.
The primary outcome of the study was pain severity, assessed using the Visual Analogue Scale. Secondary outcomes included physical activity level, disability related to low back pain, anxiety symptoms, quality of life, and mindfulness level.
Participants were evaluated at baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up).
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Balçova
-
Izmir, Balçova, Turquia (Türkiye), 35340
- Dokuz Eylul University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Staff member of Dokuz Eylül University
- Aged between 20 and 59 years
- Willing to participate in the study
- Having low back pain for at least 3 months
- Working at a desk for more than 4 hours per day
- Having access to an internet connection at home or at work
- Having a computer and/or smartphone suitable for participating in online sessions and completing online forms
Exclusion Criteria:
- Presence of an organic condition that could explain low back pain, such as lumbar disc herniation
- Presence of an underlying rheumatological disease, such as ankylosing spondylitis or rheumatoid arthritis
- Diagnosed psychiatric disorder
- Alcohol or substance dependence
- Current use of psychiatric medication
- Pregnancy
- Speech or hearing problems that could interfere with participation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Mindfulness-Based Therapy Group
Participants in this arm received a four-week online mindfulness-based therapy program.
The program consisted of weekly 60-90-minute group sessions delivered online in small groups of approximately 8-10 participants.
The sessions included breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices.
Participants were also encouraged to practise breathing awareness and body scan exercises at home for 10-15 minutes daily and to record their practice using a mindfulness practice log.
|
The intervention was a four-week online mindfulness-based therapy program delivered in small groups of approximately 8-10 participants.
Participants attended one 60-90-minute online group session per week.
The program included breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices adapted for office workers with non-specific chronic low back pain.
Each session included a brief theoretical introduction, guided practice, participant reflection, and a question-and-answer section.
Participants were encouraged to practise breathing awareness and body scan exercises at home for 10-15 minutes daily and to record their practice, thoughts, and emotions using a mindfulness practice log.
|
|
Sem intervenção: Usual Care Control Group
Participants in this arm continued their usual medical care during the study period and did not receive the mindfulness-based therapy program during the active study phase.
After completion of the six-month follow-up assessment, participants were provided with video and audio recordings and written materials introducing the mindfulness techniques used in the intervention group.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Pain Severity on the Visual Analogue Scale
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Pain severity was assessed using the Visual Analogue Scale (VAS), a 0-100 scale in which higher scores indicate greater pain severity.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Physical Activity Level on the International Physical Activity Questionnaire Short Form
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Physical activity level was assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF).
The questionnaire assesses walking, moderate-intensity activity, vigorous-intensity activity, and sitting time during the previous 7 days.
Physical activity is reported as metabolic equivalent task minutes per week (MET-min/week).
Higher MET-min/week values indicate higher physical activity levels.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
|
Change From Baseline in Low Back Pain-Related Disability on the Roland-Morris Disability Questionnaire
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Low back pain-related functional disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ).
The questionnaire includes 24 items scored as 0 or 1, resulting in a total score ranging from 0 to 24.
Higher scores indicate greater functional disability.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
|
Change From Baseline in Health-Related Quality of Life on the Short Form-36 Health Survey
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36).
The SF-36 evaluates multiple domains of health-related quality of life.
Domain scores range from 0 to 100, with higher scores indicating better health status.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
|
Change From Baseline in Anxiety Symptoms on the Beck Anxiety Inventory
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI).
The scale includes 21 items, each scored from 0 to 3, resulting in a total score ranging from 0 to 63.
Higher scores indicate greater anxiety symptom severity.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
|
Change From Baseline in Mindfulness Level on the Five Facet Mindfulness Questionnaire Short Form
Prazo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Mindfulness level was assessed using the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF).
The questionnaire evaluates five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Higher scores indicate higher mindfulness levels.
|
Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Outros números de identificação do estudo
- DEU-2021-27-08
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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 .