- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501910
Telerehabilitation Program in Lumbar Disc Herniation
Development of a Telerehabilitation-Based Exercise and Monitoring Program and Its Effectiveness Compared With a Brochure-Based Home Exercise Program in Patients With Lumbar Disc Herniation: A Randomized Controlled Trial
The aim of this study was to develop an asynchronous, web-based telerehabilitation exercise and monitoring program and to compare its effectiveness with a traditional brochure-based home exercise program in patients with lumbar disc herniation. The study was designed as a randomized controlled trial including 46 participants who were allocated into two groups: a telerehabilitation group and a brochure-based exercise group.
Both groups participated in a structured 4-week home exercise program. The telerehabilitation group received exercise guidance and follow-up through a web-based digital platform, which enabled remote monitoring of exercise adherence and patient-reported outcomes. The brochure group performed the same exercises using printed instructional materials.
Participants were evaluated before and after the intervention using standardized and validated assessment tools, including the Visual Analog Scale (VAS) for pain, the Oswestry Disability Index (ODI) for functional disability, the SF-12 for quality of life, and tests for static and dynamic lumbar muscle strength and endurance.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
his study is a randomized controlled clinical trial designed to compare two different delivery methods of a home-based exercise program in patients diagnosed with lumbar disc herniation. The primary focus of the study is to evaluate the effectiveness of a web-based telerehabilitation exercise and monitoring program compared with a traditional brochure-based home exercise program.
A total of 46 eligible participants are randomly assigned into two groups: a telerehabilitation group and a brochure-based exercise group. Both groups follow the same structured home exercise program for a duration of four weeks, consisting of standardized exercises performed three times per week.
Participants in the telerehabilitation group access exercise instructions through a web-based digital platform that includes video demonstrations, written guidance, and remote monitoring features. The platform allows participants to record their exercise sessions and enables physiotherapists to monitor adherence and provide feedback when necessary. The intervention is delivered asynchronously, without real-time interaction.
Participants in the brochure group receive printed materials containing the same exercises, including visual and written instructions. Initial instruction is provided face-to-face, after which participants continue the exercise program independently at home.
Outcome assessments are conducted before and after the intervention by a physiotherapist who is blinded to group allocation. Evaluations include pain intensity, functional disability, quality of life, and lumbar muscle strength and endurance, using standardized and validated measurement tools.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Meram
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Konya, Meram, Turkey (Türkiye), 42090
- Necmettin Erbakan University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 65 years
- Diagnosed with lumbar disc herniation by a specialist physician
- Presence of bulging or protrusion stage lumbar disc herniation
- Willing to participate and provide informed consent
- Having basic smartphone or computer skills and access to the internet (for the telerehabilitation group
Exclusion Criteria:
- History of spinal surgery
- Presence of extruded or sequestered lumbar disc herniation
- Visual or hearing impairment that may affect participation
- Presence of spinal tumors
- Communication or cognitive problems preventing participation
- Inability to understand Turkish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telerehabilitation Group
Participants received a web-based telerehabilitation exercise and monitoring program including video-guided exercises, remote monitoring of adherence, and asynchronous follow-up via a digital platform.
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Participants performed a structured home exercise program delivered through a web-based telerehabilitation platform.
The program included video-guided exercises, written instructions, and asynchronous remote monitoring.
Participants recorded their exercise sessions, and physiotherapists monitored adherence and provided feedback through the digital system.
The intervention was conducted for 4 weeks, 3 days per week, with 3 sets of 10 repetitions for each exercise.
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|
Active Comparator: Brochure Group
Participants received a brochure-based home exercise program including printed instructions and visual materials, with initial face-to-face instruction and no remote monitoring.
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Participants performed the same structured home exercise program using printed brochures that included visual and written instructions.
Exercises were initially demonstrated face-to-face, and participants continued independently at home without remote monitoring.
The program was applied for 4 weeks, 3 days per week, with 3 sets of 10 repetitions for each exercise.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity assessed by Visual Analog Scale (VAS)
Time Frame: Baseline and after 4 weeks
|
Pain intensity assessed by the Visual Analog Scale (VAS) Pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain severity. The assessment includes overall pain, pain at rest, pain during activity, and night pain. [Time Frame: Baseline and after 4 weeks]Pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain severity. The assessment includes overall pain, pain at rest, pain during activity, and night pain. |
Baseline and after 4 weeks
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|
Functional disability (ODI)
Time Frame: Baseline and after 4 weeks
|
Functional disability assessed by the Oswestry Disability Index (ODI) Functional disability measured using the Oswestry Disability Index (ODI), a questionnaire consisting of 10 items scored from 0 to 5, with a total score ranging from 0 to 50. Higher scores indicate greater disability. |
Baseline and after 4 weeks
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|
Quality of life (SF-12)
Time Frame: Baseline and after 4 weeks
|
Quality of life assessed by the 12-Item Short Form Health Survey (SF-12) Quality of life measured using the 12-Item Short Form Health Survey (SF-12), which generates physical (PCS) and mental (MCS) component summary scores ranging from 0 to 100. Higher scores indicate better health-related quality of life. |
Baseline and after 4 weeks
|
|
Static trunk muscle endurance
Time Frame: Baseline and after 4 weeks
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Static trunk muscle endurance assessed using Diener's trunk muscle test Static trunk muscle endurance measured using Diener's (1992) trunk muscle test, expressed as the duration (seconds) the participant maintains the trunk flexion position until the inferior angle of the scapula lifts off the surface. The maximum score is 30 seconds. Higher values indicate greater trunk muscle endurance. |
Baseline and after 4 weeks
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|
Dynamic trunk muscle endurance
Time Frame: Baseline and after 4 weeks
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Dynamic trunk muscle endurance assessed using Diener's trunk muscle test Dynamic trunk muscle endurance measured using Diener's (1992) trunk muscle test, expressed as the number of complete trunk flexion repetitions performed within 30 seconds. Higher values indicate greater trunk muscle endurance. |
Baseline and after 4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-PT2025-05
- 24YL30002 (Other Identifier: Necmettin Erbakan University Scientific Research Projects Coordinatorship)
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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