Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-29 @ 7:41 AM
Study NCT ID:
NCT06030960
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2023-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2023-09-03', 'studyFirstSubmitQcDate': '2023-09-03', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postural stability', 'timeFrame': '12 weeks', 'description': 'Centre of Pressure (CoP) movements will be tracked by a multi-sensory platform + Body Weight Balance (static):'}, {'measure': 'Proprioception', 'timeFrame': '12 weeks', 'description': 'Ankle and Trunk Joint Position Sense (JPS)'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '12 weeks', 'description': 'Visual Analog Scale (VAS)'}, {'measure': 'Pain Self-Efficacy Questionnaire (PSEQ-Ar)', 'timeFrame': '12 weeks', 'description': "to examine one's beliefs, level of Pain intensity and actual achievements contributions to performance"}, {'measure': 'Activities-specific Balance Confidence (ABC)', 'timeFrame': '12 weeks', 'description': 'Active clinical assessment measures of balance and function'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': '12 weeks', 'description': 'Overstressed undesirable perceptions of pain and the ambiance surrounding its involvement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LBP', 'Psychological effects', 'Intervention', 'Virtual Reality', 'postural stability', 'balance', 'pain', 'COP'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'To our knowledge, no studies have better investigated the effect of Core Stabilization Exercises using VR on ankle and trunk proprioception in patients with CLBP and in turn on postural stability.', 'detailedDescription': 'Background: Low Back Pain (LBP), one of the most critical disability causatives, has been associated with neuromuscular and biomechanical manifestations related to the deficiency of postural control and stability. Virtual reality (VR) core stabilization exercises (CSE) has proven previously to be effective in improving postural control among conditions with different proprioceptive damage mechanisms other than those affected with LBP. The Aim of this study is to explore the differing effects of this treatment regimen on postural stability in relation to lumbar and ankle proprioception in a population of participants with LBP. Design and Methods: a randomized clinical trial encompassing 44 participants of both genders. Participants with Chronic Low Back Pain (CLBP) will be randomized to one of two treatment groups: an Experimental group receiving VR stabilization exercises and a Control group receiving CSE only without VR simulations inaddition to patient instructions and education of both groups. Parameters of postural stability, ankle and trunk proprioception, pain intensity, balance interference with activity and psychological aspects of pain interference with activity will be measured by a force plate, iPhone applications, visual analog scale (VAS), the Activities-specific Balance Confidence (ABC) scale, Pain Catastrophizing Scale (PCS) and the Pain Self-Efficacy Questionnaire (PSEQ-Ar) respectively. Outcome measures will be collected at baseline, immediately after 1st treatment and after the last treatment session. Treatment regimens will consist of 12 sessions in 3 weeks using virtual reality glasses. Statistical Analysis: A linear mixed model will be used to analyze within- and between-group differences at the baseline, 6th session and twelfth sessions (repeated measures will be set as GROUP with two levels and TIME with three levels). Bonferroni post-hoc procedures will be used for multiple comparisons of the differences over time. Intention-to-treat analysis shall be utilized. Statistical significance was set at P \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients in Group 1 and Group 2 will be included if they:\n\n1. Are adults between 25 and 59 years of age.\n2. Have LBP for longer than 3 months.\n3. Are not currently undergoing medication or conservative treatment.\n\nExclusion Criteria:\n\nPatients in these two groups will be excluded if they have:\n\n1. Nerve root manifestations (such as referred symptoms of radiating pain below the knee or paresthesia during the straight leg raise test),\n2. Systematic or visceral disease,\n3. Ankylosing spondylitis, Spondylolysis and Spondylolisthesis,\n4. Vestibular dysfunctions,\n5. Body mass index (BMI) ≥ 30 kg/m2,\n6. Lower extremity injury within the past month,\n7. Concussion,\n8. Psychiatric, cardiovascular or musculoskeletal disorders,\n9. Vision problems,\n10. Vertebral fracture,\n11. Spinal Stenosis,\n12. Previous spinal surgery,\n13. Present pregnancy,\n14. Scoliosis,\n15. Inability to understand instructions, read or write (Li et al., 2021).'}, 'identificationModule': {'nctId': 'NCT06030960', 'acronym': 'VR', 'briefTitle': 'Effects of Virtual Reality Stabilization Training in Patients With Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'The Effects of Virtual Reality Stabilization Training on Postural Stability and Proprioception in Patients With Low Back Pain', 'orgStudyIdInfo': {'id': 'IRB-PGS-2023-03-097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients with Chronic Low Back Pain (CLBP) who will receive Virtual Reality (VR) stabilization exercises, regular stabilization exercises and patient instructions and education', 'interventionNames': ['Device: Virtual Reality (VR)', 'Other: Regular Exercises', 'Other: patient instructions and education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Patients with Chronic Low Back Pain (CLBP) who will receive regular stabilization exercises and patient instructions and education', 'interventionNames': ['Other: Regular Exercises', 'Other: patient instructions and education']}], 'interventions': [{'name': 'Virtual Reality (VR)', 'type': 'DEVICE', 'otherNames': ['Exergames'], 'description': 'Virtual Reality (VR) Stabilization Exercises', 'armGroupLabels': ['Group 1']}, {'name': 'Regular Exercises', 'type': 'OTHER', 'description': 'Regular Stabilization Exercises', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'patient instructions and education', 'type': 'OTHER', 'description': 'a unified form of patient instructions and education in regards of LBP', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dammam', 'state': 'Eastern Province', 'country': 'Saudi Arabia', 'facility': 'Dammam Medical Complex', 'geoPoint': {'lat': 26.43442, 'lon': 50.10326}}], 'overallOfficials': [{'name': 'Ali AlShami, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'alshami@iau.edu.sa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rehabilitation Sciences PhD Student', 'investigatorFullName': 'Abrar AlSadiq', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}