The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chronic Low Back Pain

NCT07031947 | Active Not Recruiting

• 1 other identifier: E-29624016-050.04-2603725
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 80 patients, aged between 20 and 60 years, diagnosed with non-specific low back pain and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2024 and June 1, 2025, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. After the patients are informed verbally and in writing about the purpose, duration and application method of the study and their consent is obtained, they will be asked to sign the "Informed Consent Form". Patient evaluation and follow-up forms will be filled out during pre-treatment and post-treatment follow-ups. After patients who meet the study inclusion criteria are included in the study, they will be numbered according to the order of application and then randomly assigned to the intervention group or control group by a computer program into 2 groups. In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks. The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.

Conditions

Low Back Pain and Core Muscle; Low Back Pain; Low Back Pain, Mechanical; Core Stabilization Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• Oswestry Low Back Pain Disability Index

  It is a commonly used and validated scale for measuring disability in low back pain. It consists of a total of 10 questions. Each question is scored on a scale of 0 to 5. Higher scores indicate worse symptoms or functioning.

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

• Visuel Analog Scale

  The severity of pain before treatment is assessed using the Visual Analog Scale (VAS), a 10 cm long line with "no pain" on the left end and "unbearable pain" on the right end. The distance in centimeters between the point marked by the patient and the 0 point is measured. The average pain level before and after treatment will be evaluated using the VAS, scored between 0 and 10; 0 indicates no pain, and 10 indicates the worst possible pain.

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

Secondary Outcomes (4)

• Roland Morris Disability Questionnaire

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

• Tampa Kinesiophobia Fatigue Scale

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

• Measurement of Bilateral Lumbar Multifidus and Transversus Abdominis Muscle Thickness with Ultrasound Imaging

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

• Assessment of Trunk Muscle Strength with Computerized Isokinetic Dynamometer

  Day 1 (before starting treatment), Day 60 (end of treatment), Day 120 (two months after the end of treatment)

Study Arms (2)

Telerehabilitation Group

ACTIVE COMPARATOR

Other: Core stabilization exercise with telerehabilitation

Face-to-face rehabilitation group

OTHER

Other: Face-to-face core stabilization exercise

Interventions

Core stabilization exercise with telerehabilitation OTHER

In addition to a brochure containing patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, the intervention group (G1) will receive a back school program in a total of 2 sessions of videoconference interviews, and the exercises will be explained to them, supported by visuals and videos. In addition, patients will be provided with the application that will be provided with your support, and will be provided with core stabilization exercises 3 times a week for 8 weeks.

Telerehabilitation Group

Face-to-face core stabilization exercise OTHER

The control group (G2) will receive a brochure that includes patient education, showing the application method of core stabilization exercises, the number of sets and repetitions, as well as a face-to-face back school program in our hospital for a total of 2 sessions. The exercise program will be carried out face to face, 3 sessions per week for 8 weeks, at the Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, under the supervision of a physician, with each exercise session being in groups of 8 people.

Face-to-face rehabilitation group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 20 and 60 years of age Non-specific low back pain lasting more than 3 months (VAS \> 2) No neurological deficits such as abnormal sensation, loss of muscle strength, or loss of reflexes in the lower extremity No indication for surgery Able to attend treatment 3 days a week for 8 weeks

You may not qualify if:

• Participating in a physical therapy or exercise program in the last 3 months Previous surgery, dislocation, or fracture in the lumbar region Rheumatic / autoimmune disease Serious cardiovascular disease, progressive neurological deficit, severe osteoporosis, or metabolic diseases Having a systemic disease that can cause back pain Pregnancy or lactation Uncontrolled hypertension Having problems perceiving verbal commands Not having internet access Not having equipment to make video calls at home Not having a device at home to use the application

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University Research Fund: collaborator

Study Sites (1)

Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)