NCT07005765

Brief Summary

This randomized controlled study aims to evaluate the effectiveness of a 6-week home-based stabilization exercise program in individuals with non-specific chronic low back pain. Participants will be randomly assigned to two groups: one receiving exercise instruction via video-based content, and the other via a printed brochure with illustrated exercises. The effectiveness of the interventions will be assessed in terms of pain severity, functional status, exercise adherence, kinesiophobia, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
Last Updated

June 12, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 23, 2025

Last Update Submit

June 9, 2025

Conditions

Keywords

Chronic Low Back PainCore ExerciseExercise Adherence

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia

    Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated self-report questionnaire that evaluates fear of movement or re-injury. The scale consists of 17 items rated on a 4-point Likert scale. The total score varies between 17 and 68. Higher scores indicate greater levels of fear.

    Baseline and after 6 weeks of intervention

Secondary Outcomes (4)

  • Pain Intensity

    Baseline and after 6 weeks

  • Functional Disability

    Baseline and after 6 weeks

  • Change in Quality of Life

    Baseline and after 6 weeks

  • Exercise Adherence

    At the end of the 6-week intervention

Study Arms (2)

Video-Based Exercise Group

EXPERIMENTAL

Participants receive stabilization exercises delivered via video for 6 weeks.

Behavioral: Video-Based Stabilization Exercise Program

Brochure-Based Exercise Group

EXPERIMENTAL

Participants receive the same stabilization exercises through illustrated brochures for 6 weeks.

Behavioral: Brochure-Based Stabilization Exercise Program

Interventions

Participants will follow a 6-week home exercise program focusing on stabilization exercises. The instructions and demonstrations will be delivered through video format, which participants can watch at their convenience. The program aims to improve pain, functionality, exercise adherence, kinesiophobia, and quality of life.

Video-Based Exercise Group

Participants will follow the same 6-week home exercise program using illustrated printed brochures that provide step-by-step instructions for stabilization exercises. This format allows participants to perform exercises independently. The program's effects on pain, functionality, exercise adherence, kinesiophobia, and quality of life will be evaluated.

Brochure-Based Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of non-specific chronic low back pain lasting 3 months or more
  • Age 18 years or older
  • Score of 4 or higher on the Roland-Morris Disability Questionnaire
  • Voluntary agreement to participate in the study

You may not qualify if:

  • Physiotherapy treatment for low back pain within the past 6 months
  • Pain radiating to the lower extremities
  • Pregnancy
  • History of spinal surgery
  • Presence of central or peripheral nervous system pathology (e.g., stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camlik Medical Center

Istanbul, Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Melike Kalaycı, PhD, PT

    Bahçeşehir University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to their group assignment and will not know whether they receive video-based or brochure-based exercise instructions. However, investigators delivering the interventions will be aware of the assignments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with non-specific chronic low back pain will be randomly assigned into two parallel groups. One group will receive a 6-week home-based stabilization exercise program delivered via video instructions, while the other group will receive the same exercise program using illustrated printed brochures. Both groups will follow the intervention independently without crossover. The effectiveness of the interventions will be compared between groups after 6 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's Student and Principal Investigator

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 5, 2025

Study Start

March 3, 2025

Primary Completion

April 11, 2025

Study Completion

April 14, 2025

Last Updated

June 12, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations