NCT07501910

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

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

May 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

March 19, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Digital HealthDigital RehabilitationExercise AdherenceLumbar Disc HerniationPatient Monitoring Systems

Outcome Measures

Primary Outcomes (5)

  • Pain intensity assessed by Visual Analog Scale (VAS)

    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

  • Functional disability (ODI)

    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

  • Quality of life (SF-12)

    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

    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

  • Dynamic trunk muscle endurance

    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

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

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.

Other: Web-Based Telerehabilitation Exercise Program

Brochure Group

ACTIVE COMPARATOR

Participants received a brochure-based home exercise program including printed instructions and visual materials, with initial face-to-face instruction and no remote monitoring.

Other: Brochure-Based Home Exercise Program

Interventions

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.

Telerehabilitation Group

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.

Brochure Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Outcome assessments were conducted by a physiotherapist who was blinded to group allocation. Participants and care providers were not blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a two-arm, parallel-group randomized controlled trial comparing a web-based telerehabilitation exercise and monitoring program with a brochure-based home exercise program in patients with lumbar disc herniation. Participants are randomly allocated to one of the two groups and follow a standardized 4-week home exercise protocol. Outcome assessments are conducted before and after the intervention by a blinded assessor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 30, 2026

Study Start

May 1, 2024

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to privacy and confidentiality concerns. The data contain potentially identifiable information and are protected under ethical and institutional regulations. However, de-identified data may be made available from the corresponding author upon reasonable request.

Locations