Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT06709105
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Kinesiotaping in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055052', 'term': 'Athletic Tape'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D001458', 'term': 'Bandages'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS)', 'timeFrame': 'up to 30 minutes', 'description': 'The Visual Analogue Scale (VAS) has been widely used in numerous studies to assess the intensity of pain and is considered a reliable and valid tool. It measures subjectively perceived pain on a scale resembling a 0-10 cm ruler, with one end representing no pain and the other indicating the most severe pain.'}], 'secondaryOutcomes': [{'measure': 'Pittsburgh sleep quality index', 'timeFrame': 'up to 30 minutes', 'description': "The sleep quality scale, developed by Buysse et al., had its Turkish reliability and validity study conducted by Agargün et al. (1996) This scale assesses an individual's sleep quality over the past month and includes 24 items. Of these, 19 are self-reported questions answered by the individual, and five are answered by a roommate or spouse."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kinesiotaping', 'Low Back Pain', 'Pregnancy'], 'conditions': ['KINESIOTAPING']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.', 'detailedDescription': 'Lumbar-sacral spinal pain is a medical and socioeconomic problem affecting approximately 80% of the population. Pregnancy predisposes women to this pain. The most well-known cause of low back pain during pregnancy is an increase in lumbar lordosis, a lordotic syndrome that develops rapidly due to the pregnant uterus and maternal weight gain. This lordotic posture and the related change in load distribution, along with lengthening abdominal muscles and shortening lumbar muscles, create a mechanical disadvantage. The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-32-week pregnant women without neurologic deficits\n* Females with mechanical low back pain\n* VAS of at least 3\n\nExclusion Criteria:\n\n* High-risk pregnant women with twin pregnancy\n* Placenta previa\n* Pre-eclampsia\n* Threatened preterm delivery\n* Orthopedic and rheumatologic diseases\n* Radiculopathy'}, 'identificationModule': {'nctId': 'NCT06709105', 'briefTitle': 'The Effect of Kinesiotaping in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Firat University'}, 'officialTitle': 'The Effect of Kinesiotaping on Clinical Parameters in Pregnant Women With Mechanical Low Back Pain', 'orgStudyIdInfo': {'id': '192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinesiotape application', 'description': 'The application was performed using 5 cm x 5 m kinesio tape material. After preparing the standing patient in terms of clothing and skin readiness, the patient was asked to lean forward. To adhere the tape to the right paravertebral region, the lower end of the tape was first adhered 7 cm below the sacroiliac joint at the level of the paravertebral muscles. Then, while the patient was leaning forward, a slight rotation to the left was requested, and in this position, the tape was adhered upwards along the paravertebral muscles without any tension. When applying the tape to the left paravertebral region, the same procedure was mirrored as on the right, with the tape again applied without any tension. The third tape was applied while the patient was standing upright and leaning slightly forward, placed over the sacroiliac joints and parallel to the floor, stretching the tape by 25%.', 'interventionNames': ['Other: Kinesiotape']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Sham Kinesio taping was applied to the patients in the control group. In this sham protocol, Kinesio bands were attached between the 12th rib on both sides and the corresponding sacroiliac joint, passing over the paravertebral muscles without employing any specific banding technique. The third tape was adhered between both sacroiliac joints, also without any adhesive technique. Patients were inquired about any discomfort and informed that the tapes would remain in place until the second session.', 'interventionNames': ['Other: Sham (no implant)']}], 'interventions': [{'name': 'Kinesiotape', 'type': 'OTHER', 'description': 'The application was performed using 5 cm x 5 m kinesio tape material. After preparing the standing patient in terms of clothing and skin readiness, the patient was asked to lean forward. To adhere the tape to the right paravertebral region, the lower end of the tape was first adhered 7 cm below the sacroiliac joint at the level of the paravertebral muscles. Then, while the patient was leaning forward, a slight rotation to the left was requested, and in this position, the tape was adhered upwards along the paravertebral muscles without any tension. When applying the tape to the left paravertebral region, the same procedure was mirrored as on the right, with the tape again applied without any tension. The third tape was applied while the patient was standing upright and leaning slightly forward, placed over the sacroiliac joints and parallel to the floor, stretching the tape by 25%.', 'armGroupLabels': ['Kinesiotape application']}, {'name': 'Sham (no implant)', 'type': 'OTHER', 'description': 'Sham Kinesio taping was applied to the patients in the control group. In this sham protocol, Kinesio bands were attached between the 12th rib on both sides and the corresponding sacroiliac joint, passing over the paravertebral muscles without employing any specific banding technique. The third tape was adhered between both sacroiliac joints, also without any adhesive technique. Patients were inquired about any discomfort and informed that the tapes would remain in place until the second session.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23119', 'city': 'Elâzığ', 'state': 'Firat University', 'country': 'Turkey (Türkiye)', 'facility': 'Muhammet Şahin Elbastı', 'geoPoint': {'lat': 38.67431, 'lon': 39.22321}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Physical Medicine and Rehabilitation Departmant', 'investigatorFullName': 'Muhammet Sahin Elbasti', 'investigatorAffiliation': 'Firat University'}}}}