Non-specific Chronic Low Back PainNCT07621302
Mindfulness-Based Therapy for Chronic Low Back Pain in Office Workers
A study testing Mindfulness-Based Therapy Program in people with Non-specific Chronic Low Back Pain and Chronic Low-back Pain (cLBP), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 59 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain, Chronic Low-back Pain (cLBP), Mindfulness Meditation
- What is being tested?
- Mindfulness-Based Therapy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 23 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
- Being tested
- Mindfulness-Based Therapy Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Therapy ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Therapy Group | Experimental | 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. Receives: Behavioral: Mindfulness-Based Therapy Program |
| Usual Care Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Severity on the Visual Analogue Scale
Pain severity was assessed using the Visual Analogue Scale (VAS), a 0-100 scale in which higher scores indicate greater pain severity.
Measured: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
Secondary outcomes (5)
Change From Baseline in Physical Activity Level on the International Physical Activity Questionnaire Short Form
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start4 Apr 2022
- Primary completion6 Jun 2022
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a four-week online mindfulness-based therapy group or a control group receiving usual medical care. The intervention group attended weekly online group sessions including breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Sevindi İmançer, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621302
- Sponsor's protocol ID
- DEU-2021-27-08
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Only aggregate study results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Therapies on Pain Severity in Office Workers With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07621302
- Acronym / sponsor ID
- DEU-2021-27-08
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either a four-week online mindfulness-based therapy group or a control group receiving usual medical care. The intervention group attended weekly online group sessions including breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Therapy Group | Experimental | Behavioral: Mindfulness-Based Therapy ProgramParticipants 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. |
| Usual Care Control Group | No intervention | –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. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Therapy ProgramThe 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. | Behavioural | Mindfulness-Based Therapy Group |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Only aggregate study results will be reported in publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Therapy Program in people with Non-specific Chronic Low Back Pain and Chronic Low-back Pain (cLBP), run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.