- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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).
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Balçova
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Izmir, Balçova, Turchia (Türkiye), 35340
- Dokuz Eylul University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Pain Severity on the Visual Analogue Scale
Lasso di tempo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Pain severity was assessed using the Visual Analogue Scale (VAS), a 0-100 scale in which higher scores indicate greater pain severity.
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Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Physical Activity Level on the International Physical Activity Questionnaire Short Form
Lasso di tempo: 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.
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Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Change From Baseline in Low Back Pain-Related Disability on the Roland-Morris Disability Questionnaire
Lasso di tempo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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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.
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Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Change From Baseline in Health-Related Quality of Life on the Short Form-36 Health Survey
Lasso di tempo: 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.
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Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Change From Baseline in Anxiety Symptoms on the Beck Anxiety Inventory
Lasso di tempo: 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.
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Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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Change From Baseline in Mindfulness Level on the Five Facet Mindfulness Questionnaire Short Form
Lasso di tempo: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
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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)
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- DEU-2021-27-08
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