- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Balçova
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Izmir, Balçova, Turkey (Türkiye), 35340
- Dokuz Eylul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Pain Severity on the Visual Analogue Scale
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Physical Activity Level on the International Physical Activity Questionnaire Short Form
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
|
Change From Baseline in Mindfulness Level on the Five Facet Mindfulness Questionnaire Short Form
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DEU-2021-27-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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