- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07208435
- Original Trial
Web-Based Exercise Program for Non-Specific Low Back Pain (WEBEX-LBP)
Effectiveness of Web-Based Exercise Programs in the Management of Non-Specific Low Back Pain: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Non-specific low back pain (NSLBP) is a prevalent condition associated with pain, functional limitations, and reduced quality of life. Access to in-person physiotherapy can be limited by geographic, financial, or time-related constraints. Web-based exercise programs offer an accessible alternative by delivering personalized exercises, educational content, reminders, and self-monitoring tools via digital platforms.
This study aims to investigate whether a structured web application-based exercise program can improve outcomes for adults with NSLBP compared to traditional home exercises. The trial addresses gaps in current evidence regarding the effectiveness of telerehabilitation, patient engagement, and delivery modes, and seeks to determine if digital interventions can serve as a viable complement or alternative to conventional physiotherapy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yağmur Mustafaoğlu, PT, MSc (Cand.)
- Phone Number: +905397974655
- Email: yagmurmustafaoglu84@gmail.com
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey (Türkiye), 34810
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-45 years diagnosed with non-specific low back pain (NSLBP) for 6 weeks to <12 months.
- Self-reported pain intensity ≥3 on a 0-10 Numeric Pain Rating Scale (NPRS).
- Evidence of functional limitation (Oswestry Disability Index or Roland-Morris Disability Questionnaire).
- Access to a smartphone, tablet, or computer with internet connectivity.
- Ability and willingness to participate in telerehabilitation programs.
Exclusion Criteria:
- Specific causes of low back pain (herniated disc with radiculopathy, spinal stenosis, spondylolisthesis, fractures, infections, malignancy).
- Neurological deficits (e.g., severe motor weakness, progressive neurological symptoms).
- Severe psychiatric or cognitive disorders interfering with participation.
- History of spinal surgery within the last year.
- Severe comorbidities contraindicating exercise (e.g., uncontrolled diabetes, cardiovascular disease).
- Pregnant or planning pregnancy during the study period.
- Active substance or alcohol abuse.
- Participation in other structured rehabilitation or physical therapy programs within the last 3 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-Based Exercise Program
Participants complete an 8-week web-based exercise program via Physitrack.
Sessions last 30-45 minutes, twice per week, focusing on core strengthening, spinal mobility, posture correction, and pain reduction.
Exercises progress weekly from basic core engagement to advanced trunk control and integration.
|
Participants complete an 8-week web-based therapeutic exercise program via Physitrack, with 30-45 minute sessions twice weekly.
The program targets core strengthening, spinal mobility, posture correction, and pain reduction.
Exercises progress weekly from basic core engagement and breathing techniques to advanced trunk control, dynamic movements, and integration.
The platform provides instructional videos, reminders, educational content, and self-monitoring tools to enhance adherence, engagement, and self-management.
|
|
Active Comparator: Traditional Home Exercise Program
Participants complete a 6-week traditional home exercise program.
Sessions last 30-40 minutes, focusing on flexibility, basic trunk and core strengthening, balance, and ergonomic practice.
Exercises progress weekly, emphasizing pain relief, trunk mobility, and functional strength.
|
Participants follow a 6-week traditional home exercise program with 30-40 minute sessions, twice weekly.
The program focuses on flexibility, basic trunk and core strengthening, balance, and ergonomic practice.
Exercises progress weekly, including cat-cow stretches, pelvic tilts, glute bridges, partial curl-ups, bird-dog, lunges, and posture training.
Participants perform exercises independently at home using printed instructions, aiming to reduce pain, improve spinal mobility, and enhance functional outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Reduction (Numeric Pain Rating Scale, NPRS)
Time Frame: Baseline and 6 weeks after intervention
|
Change in self-reported low back pain intensity from baseline to 6 weeks, measured using the Numeric Pain Rating Scale (NPRS), where 0 = no pain and 10 = worst imaginable pain.
Participants report their average pain over the past 24 hours.
|
Baseline and 6 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Disability (Oswestry Disability Index, ODI)
Time Frame: Baseline and 6 weeks after intervention
|
Change in disability due to low back pain from baseline to 6 weeks, measured using the ODI, which evaluates daily activities such as pain intensity, personal care, lifting, walking, sitting, and sleeping.
Higher scores indicate greater disability.
|
Baseline and 6 weeks after intervention
|
|
Quality of Life (Short Form Health Survey, SF-36)
Time Frame: Baseline and 6 weeks after intervention
|
Change in health-related quality of life from baseline to 6 weeks across physical and mental health domains
|
Baseline and 6 weeks after intervention
|
|
Patient Satisfaction Questionnaire (PSQ)
Time Frame: 6 weeks end of intervention
|
Participants' satisfaction with the intervention, including ease of use, communication, and perceived effectiveness.
|
6 weeks end of intervention
|
|
Proprioception (Joint Position Sense Test, JPS)
Time Frame: Baseline and 6 weeks after intervention
|
Change in lumbar spine proprioception from baseline to 6 weeks.
|
Baseline and 6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Merve Yılmaz Menek, Assoc. Prof, Assoc. prof. Merve Yılmaz Menek
Publications and helpful links
General Publications
- Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
- Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.
- Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
- Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
- Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
- Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
- Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000 Jan;84(1):95-103. doi: 10.1016/S0304-3959(99)00187-6.
- Bini SA, Schilling PL, Patel SP, Kalore NV, Ast MP, Maratt JD, Schuett DJ, Lawrie CM, Chung CC, Steele GD. Digital Orthopaedics: A Glimpse Into the Future in the Midst of a Pandemic. J Arthroplasty. 2020 Jul;35(7S):S68-S73. doi: 10.1016/j.arth.2020.04.048. Epub 2020 Apr 22.
- Searle A et al., 2015
- Hayden JA et al., 2005
- Qaseem A et al., 2017
- Fernández-Rodríguez R et al., 2021
- Natour J et al., 2015
- Wells C et al., 2014
- Sissel C. Pilates for Rehabilitation. 2nd ed. 2018.
- Tseli E, Tsepis E, Anastasopoulos K, et al. Telerehabilitation in patients with low back pain: systematic review and meta-analysis. J Telemed Telecare. 2022;28(3):149-63.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- E-10840098-202.3.02-3388
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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