Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-01 @ 2:58 AM
Study NCT ID:
NCT07419256
Status:
COMPLETED
Last Update Posted:
2026-02-18
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Programs in Grade I-II Spondylolisthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were assigned to one of two parallel intervention groups receiving different rehabilitation programs.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-16', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.', 'description': 'Pain intensity assessed using the Visual Analogue Scale (VAS). The patient points with their finger on the scale to indicate the intensity of pain from 0 (no pain) to 10 (the most severe pain imaginable).'}, {'measure': 'Functional disability', 'timeFrame': 'Baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.', 'description': 'Functional disability assessed using the Oswestry Disability Index (ODI). A Polish translation of the questionnaire consisting of 10 questions concerning activities of daily living was used. For each question, there are 6 possible scores from A to F. Responses are classified from 0 to 5 points, respectively. The test result is the sum of points from all questions in the questionnaire. The higher the score (maximum being 50, minimum 0) the more severe the disability.'}], 'secondaryOutcomes': [{'measure': 'Trunk muscle strength', 'timeFrame': 'Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.', 'description': 'Static strength of trunk flexor and extensor muscles assessed using torque measurements under static conditions.'}, {'measure': 'Postural stability on a force platform interpreted from meassurement of shift of the center of foot-pressure on the ground, expressed in millimeters.', 'timeFrame': 'Baseline, immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.', 'description': 'Postural stability assessed using static stabilography parameters during quiet standing. Body posture balance measurements were taken on a force platform (JBA Staniak, Poland) with dedicated software. The assessment of the body balance method consisted in the participant performing two 30-second attempts to maintain a vertical body position on a force platform, according to the procedure de-scribed by Wychowański et al. The trials took place while: standing on two lower limbs with eyes open (EO) and eyes closed (EC). As the result of the body balance test, the Trace Length (TL), plotted by the center of foot-pressure on the ground (COP), expressed in millimeters, was taken.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low back pain', 'rehabilitation', 'kinesiotherapy', 'physical therapy', 'myofascial trigger point therapy', 'Oswestry Disability Index', 'postural stability', 'spondylolisthesis'], 'conditions': ['Low Back Pain', 'Spondylolisthesis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '000000'}]}, 'descriptionModule': {'briefSummary': 'This interventional clinical study evaluated the effectiveness of two different 4-week rehabilitation programs in older adults aged 60-75 years with radiologically confirmed grade I or II spondylolisthesis. Participants were assigned to one of two parallel treatment groups. One group received a standardized kinesiotherapy program combined with physical therapy modalities, while the second group received the same kinesiotherapy program combined with myofascial trigger point therapy. Treatment effectiveness was assessed using pain intensity, functional disability, postural stability, and trunk muscle strength measures.', 'detailedDescription': 'The study was conducted as an interventional clinical trial in an outpatient rehabilitation setting in Warsaw, Poland. Participants aged 60-75 years with radiologically confirmed degenerative or isthmic spondylolisthesis grade I or II were enrolled after providing written informed consent. The study protocol was approved by the Senate Ethics Committee for Scientific Research of the Józef Piłsudski University of Physical Education in Warsaw (approval number SKE 01-47/2021).\n\nParticipants were randomly assigned to one of two parallel intervention groups using sealed envelopes. Both groups followed the same standardized kinesiotherapy exercise program. In Group 1, the exercise program was combined with physical therapy modalities. In Group 2, the same exercise program was combined with myofascial trigger point therapy instead of physical therapy. Each participant completed a 4-week rehabilitation program, with a total duration of approximately 16 hours of physiotherapy procedures.\n\nOutcome measures included pain intensity assessed using the Visual Analogue Scale (VAS), functional disability measured with the Oswestry Disability Index (ODI), postural stability assessed by static stabilography, and trunk muscle strength measured under static conditions. Assessments were performed at baseline (before the rehabilitation program), immediately after completion of the 4-week intervention, and 6 weeks after the end of the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60-75 years.\n* Radiologically confirmed grade I or II spondylolisthesis (ICD-10: M43.1).\n* No neurological symptoms.\n* Pain intensity tolerated by the patient.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Epilepsy.\n* Vertebral fractures.\n* Previous spine surgery.\n* Dizziness.\n* Internal organ diseases under specialist treatment.\n* Cardiovascular and pulmonary diseases.\n* Vestibular system disorders.'}, 'identificationModule': {'nctId': 'NCT07419256', 'briefTitle': 'Rehabilitation Programs in Grade I-II Spondylolisthesis', 'organization': {'class': 'OTHER', 'fullName': 'Józef Piłsudski University of Physical Education'}, 'officialTitle': 'Evaluation of the Effectiveness of Two 4-Week Rehabilitation Programs in Patients With Grade I or II Spondylolisthesis', 'orgStudyIdInfo': {'id': 'Rdzanek-Spondylolisthesis-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesiotherapy plus Physical Therapy', 'description': 'Participants received a standardized kinesiotherapy exercise program combined with physical therapy modalities over a 4-week rehabilitation period.', 'interventionNames': ['Other: Kinesiotherapy', 'Other: Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Kinesiotherapy plus Myofascial Trigger Point Therapy', 'description': 'Participants received the same standardized kinesiotherapy exercise program as the first group, combined with myofascial trigger point therapy instead of physical therapy, over a 4-week rehabilitation period.', 'interventionNames': ['Other: Kinesiotherapy', 'Other: Myofascial Trigger Point Therapy']}], 'interventions': [{'name': 'Kinesiotherapy', 'type': 'OTHER', 'description': 'A standardized therapeutic exercise program delivered over 4 weeks, aimed at improving trunk muscle strength, stability, and functional performance in participants with grade I-II spondylolisthesis.', 'armGroupLabels': ['Kinesiotherapy plus Myofascial Trigger Point Therapy', 'Kinesiotherapy plus Physical Therapy']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'Physical therapy modalities provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.', 'armGroupLabels': ['Kinesiotherapy plus Physical Therapy']}, {'name': 'Myofascial Trigger Point Therapy', 'type': 'OTHER', 'description': 'Manual myofascial trigger point therapy provided as part of the rehabilitation program in addition to kinesiotherapy, delivered over a 4-week period.', 'armGroupLabels': ['Kinesiotherapy plus Myofascial Trigger Point Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Independent Public Trust of Ambulatory Care Units Warszawa Praga-Północ Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Józef Piłsudski University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Justyna Rdzanek', 'investigatorAffiliation': 'Józef Piłsudski University of Physical Education'}}}}