NCT07621302

Brief 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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 24, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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

    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

    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

    Baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up)

Study Arms (2)

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.

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.

Interventions

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.

Mindfulness-Based Therapy Group

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Family Physician

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 2, 2026

Study Start

April 4, 2022

Primary Completion

June 6, 2022

Study Completion

January 23, 2023

Last Updated

June 2, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared. Only aggregate study results will be reported in publications and presentations.

Locations