Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 6:45 PM
Study NCT ID:
NCT06762951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilates Mat Versus Segmental Control Exercises in Patients with Chronic Non-Specific Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-02', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-02', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinopelvic angels', 'timeFrame': '6 weeks', 'description': 'Spinopelvic angles consists of (Sacral slope, lumber lordosis, pelvic incidence, and pelvic tilt) from the X-ray picture of the lateral view of the lumbosacral region by using CorelDraw graphic suits X7 software program. (Bhosale et al.2020)'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': '6 weeks', 'description': 'Pain intensity by using a Visual analogue scale (VAS). (Begum, and Hossain 2019)'}, {'measure': 'Functional disability', 'timeFrame': '6 weeks', 'description': 'Functional disability by using the Oswestry disability questionnaire. (Koivunen et al., 2024)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Non-Specific Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '35457772', 'type': 'BACKGROUND', 'citation': 'Dimitrijevic V, Scepanovic T, Milankov V, Milankov M, Drid P. Effects of Corrective Exercises on Lumbar Lordotic Angle Correction: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2022 Apr 18;19(8):4906. doi: 10.3390/ijerph19084906.'}, {'pmid': '35280247', 'type': 'BACKGROUND', 'citation': 'Tamartash H, Bahrpeyma F. Evaluation of Lumbar Myofascial Release Effects on Lumbar Flexion Angle and Pelvic Inclination Angle in Patients with Non-Specific Low Back Pain. Int J Ther Massage Bodywork. 2022 Mar 2;15(1):15-22. doi: 10.3822/ijtmb.v15i1.709. eCollection 2022 Mar.'}, {'pmid': '38172794', 'type': 'BACKGROUND', 'citation': 'Koivunen K, Widbom-Kolhanen S, Pernaa K, Arokoski J, Saltychev M. Reliability and validity of Oswestry Disability Index among patients undergoing lumbar spinal surgery. BMC Surg. 2024 Jan 3;24(1):13. doi: 10.1186/s12893-023-02307-w.'}, {'pmid': '32879575', 'type': 'BACKGROUND', 'citation': 'Bhosale S, Pinto D, Srivastava S, Purohit S, Gautham S, Marathe N. Measurement of spinopelvic parameters in healthy adults of Indian origin - A cross sectional study. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):883-888. doi: 10.1016/j.jcot.2019.07.013. Epub 2019 Jul 23.'}, {'pmid': '38763578', 'type': 'BACKGROUND', 'citation': 'Huang C, Hsieh YL, Chou LW, Wang JL, Chien A. Effects of pilates exercises on radiographic lumbo-pelvic alignment and range of motion in non-specific low back pain patients. J Bodyw Mov Ther. 2024 Apr;38:339-345. doi: 10.1016/j.jbmt.2023.10.004. Epub 2024 Feb 5.'}]}, 'descriptionModule': {'briefSummary': 'This study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain.', 'detailedDescription': "Low back pain (LBP) is the most common musculoskeletal condition and constitutes a global public health problem. The majority of patients (up to 90%) are categorized as having nonspecific low back pain, which is described as symptoms lack of clear particular reasons, i.e., beginning of low back pain is not known. Many clinical guidelines and systematic reviews have recommended exercise therapy as one of the preferred treatments at decreasing pain and improving function in NSLBP. In the last decade, the Pilates method has become one of the most popular exercise programmes incorporated in clinical practice. Therapeutic exercises, specifically Segmental control exercises, decrease pain, reduce disability, improve quality of life, increase muscular endurance and strength, improve segmental stability, and reduce risk of injury. Studies have shown that both segmental control exercises and Pilate's exercises are effective in the management of pain and disability in individuals with Chronic LBP. However, it appears there is dearth of empirical data establishing which is more effective between the segmental control exercises and Pilates exercises on individuals with non-specific chronic low back pain. Thus, there exist certain gaps involving the two therapeutic techniques. Therefore, this study sought to determine the effect of Pilates exercises versus segmental control exercises on spinopelvic angles, pain intensity, and functional disability in patients with chronic non-specific low back pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group: 18 to 65 years. (Yentür et al., 2021)\n* Both male and female gender will be included in the study. (Akhtar et al., 2017)\n* Nonspecific, non-radicular (axial) chronic LBP diagnosis with hyperlordosis (LBP for at least three months). (Kızıltaş et al., 2022)\n* Visual Analog Scale (VAS) score of 3 or higher. (Mannion et al., 2009)\n\nExclusion Criteria:\n\n* Patients with acute attacks of LBP. (Caglayan et al.,2014)\n* Pain referred from the lumbar to the lower extremities.\n* Serious spinal disorder including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression, and infection.\n* Fracture of vertebrae, and administered epidural injection. (Sarker et al., 2020)\n* Pregnancy and feeding\n* Structural abnormalities in the lumbar region\n* Surgical history in the lumbar spine area\n* Heart disease. (Kızıltaş et al., 2022)\n* History of Vestibular dysfunction\n* Regular Pilates/any other specific exercise program in the last 3 months. (Mehta et al.,2022)'}, 'identificationModule': {'nctId': 'NCT06762951', 'briefTitle': 'Pilates Mat Versus Segmental Control Exercises in Patients with Chronic Non-Specific Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pilates Mat Versus Segmental Control Exercises on Spinopelvic Angles in Patients with Chronic Non-Specific Low Back Pain', 'orgStudyIdInfo': {'id': 'Spinopelvic Angels In CNSLBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (A)', 'description': 'Group (A): Twenty patients will receive Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions. And conventional physiotherapy treatment which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.', 'interventionNames': ['Other: Pilates mat exercices', 'Other: Traditional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group (B)', 'description': 'Group B: Twenty patients will receive Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain) and conventional physiotherapy treatment which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks', 'interventionNames': ['Other: Segmental control exercises', 'Other: Traditional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (C)', 'description': 'Group C: Twenty patients will receive conventional physiotherapy treatment only which consists of traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS), two sessions per week for six weeks.', 'interventionNames': ['Other: Traditional physical therapy']}], 'interventions': [{'name': 'Pilates mat exercices', 'type': 'OTHER', 'description': 'Pilates mat exercise which consists of (single leg stretch + Pelvic press + Swimming + Opposite arm and leg reach + Side to side), 3 sets of 10 repetitions.', 'armGroupLabels': ['Group (A)']}, {'name': 'Segmental control exercises', 'type': 'OTHER', 'description': 'Segmental control exercise which consists of (Segmental control over primary stabilizers, Exercises in closed chain, and Exercises in open chain)', 'armGroupLabels': ['Group (B)']}, {'name': 'Traditional physical therapy', 'type': 'OTHER', 'description': 'Traditional physical therapy eg. (Back, hamstring, calf and hip flexors stretches, Abdominal curl-up exercise in supine, Back extensors exercise in prone, and Hip extensors exercises in prone along with ultrasound and Transcutaneous electrical nerve stimulation (TENS)', 'armGroupLabels': ['Group (A)', 'Group (B)', 'Group (C)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Egypt', 'country': 'Egypt', 'facility': 'Cairo Univercity'}], 'centralContacts': [{'name': 'Alyaa MAM Elgendy, Master', 'role': 'CONTACT', 'email': 'dr.alyaaelgendy55@gmail.com', 'phone': '+201111447459'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Alyaa Mohamed Ahmed Mohamed Elgendy', 'investigatorAffiliation': 'Cairo University'}}}}