Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT07208435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Web-Based Exercise Program for Non-Specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either the web-based exercise program (Physitrack) group or the traditional home exercise program group. Each group will receive their assigned intervention throughout the study period, and outcomes will be compared between groups to assess differences in pain reduction, functional improvement, and quality of life.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2025-09-27', 'studyFirstSubmitQcDate': '2025-09-27', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Reduction (Numeric Pain Rating Scale, NPRS)', 'timeFrame': 'Baseline and 6 weeks after intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Functional Disability (Oswestry Disability Index, ODI)', 'timeFrame': 'Baseline and 6 weeks after intervention', 'description': '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.'}, {'measure': 'Quality of Life (Short Form Health Survey, SF-36)', 'timeFrame': 'Baseline and 6 weeks after intervention', 'description': 'Change in health-related quality of life from baseline to 6 weeks across physical and mental health domains'}, {'measure': 'Patient Satisfaction Questionnaire (PSQ)', 'timeFrame': '6 weeks end of intervention', 'description': "Participants' satisfaction with the intervention, including ease of use, communication, and perceived effectiveness."}, {'measure': 'Proprioception (Joint Position Sense Test, JPS)', 'timeFrame': 'Baseline and 6 weeks after intervention', 'description': 'Change in lumbar spine proprioception from baseline to 6 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Specific Low Back Pain', 'NSLBP', 'Web-Based Exercise Program', 'Telerehabilitation', 'Randomized Controlled Trial', 'Physiotherapy', 'Home Exercise Program', 'Pain Management', 'Functional Improvement', 'Quality of Life'], 'conditions': ['Non-specific Low Back Pain (NSLBP)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Searle A et al., 2015'}, {'type': 'BACKGROUND', 'citation': 'Hayden JA et al., 2005'}, {'type': 'BACKGROUND', 'citation': 'Qaseem A et al., 2017'}, {'type': 'BACKGROUND', 'citation': 'Fernández-Rodríguez R et al., 2021'}, {'type': 'BACKGROUND', 'citation': 'Natour J et al., 2015'}, {'type': 'BACKGROUND', 'citation': 'Wells C et al., 2014'}, {'pmid': '1593914', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11074683', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Sissel C. Pilates for Rehabilitation. 2nd ed. 2018.'}, {'pmid': '32416956', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27141087', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '26178888', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15867409', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10601677', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27745712', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10470716', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.physitrack.com/', 'label': 'Official website for the web application used in the intervention group.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of a web application-based exercise program (delivered via Physitrack) for managing non-specific low back pain (NSLBP) compared to traditional home exercise programs. The trial focuses on whether web-based delivery can improve pain, function, quality of life, and adherence, providing evidence for digital rehabilitation as a practical alternative to conventional physiotherapy.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-45 years diagnosed with non-specific low back pain (NSLBP) for 6 weeks to \\<12 months.\n* Self-reported pain intensity ≥3 on a 0-10 Numeric Pain Rating Scale (NPRS).\n* Evidence of functional limitation (Oswestry Disability Index or Roland-Morris Disability Questionnaire).\n* Access to a smartphone, tablet, or computer with internet connectivity.\n* Ability and willingness to participate in telerehabilitation programs.\n\nExclusion Criteria:\n\n* Specific causes of low back pain (herniated disc with radiculopathy, spinal stenosis, spondylolisthesis, fractures, infections, malignancy).\n* Neurological deficits (e.g., severe motor weakness, progressive neurological symptoms).\n* Severe psychiatric or cognitive disorders interfering with participation.\n* History of spinal surgery within the last year.\n* Severe comorbidities contraindicating exercise (e.g., uncontrolled diabetes, cardiovascular disease).\n* Pregnant or planning pregnancy during the study period.\n* Active substance or alcohol abuse.\n* Participation in other structured rehabilitation or physical therapy programs within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT07208435', 'acronym': 'WEBEX-LBP', 'briefTitle': 'Web-Based Exercise Program for Non-Specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Effectiveness of Web-Based Exercise Programs in the Management of Non-Specific Low Back Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-10840098-202.3.02-3388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-Based Exercise Program', 'description': '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.', 'interventionNames': ['Behavioral: Web-Based Therapeutic Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Home Exercise Program', 'description': '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.', 'interventionNames': ['Behavioral: Traditional Home Exercise Program']}], 'interventions': [{'name': 'Web-Based Therapeutic Exercise Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Web-Based Exercise Program']}, {'name': 'Traditional Home Exercise Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Traditional Home Exercise Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Istanbul', 'state': 'Beykoz', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Yağmur Mustafaoğlu, PT, MSc (Cand.)', 'role': 'CONTACT', 'email': 'yagmurmustafaoglu84@gmail.com', 'phone': '+905397974655'}], 'overallOfficials': [{'name': 'Merve Yılmaz Menek, Assoc. Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assoc. prof. Merve Yılmaz Menek'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available from publication until 5 years post-publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) from this study, including demographic information, pain scores (NPRS), functional disability scores (ODI), quality of life (SF-36), patient satisfaction (PSQ), and proprioception measurements (JPS), may be shared upon reasonable request. Data will be anonymized to protect participant privacy, and access will be provided for academic or research purposes only.', 'accessCriteria': 'Requests must include a research proposal and approval by the principal investigator or institutional review board.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PT, MSc (Cand.)', 'investigatorFullName': 'Yağmur Mustafaoğlu', 'investigatorAffiliation': 'Medipol University'}}}}