Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-09 @ 2:57 PM
Study NCT ID:
NCT05334394
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2022-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-12', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TecnoBody Static Balance Device Measurements', 'timeFrame': '5 Minutes', 'description': 'TecnoBody Stability Easy is a stabilometric system consisting of three highly sensitive sensors. The system is based on continuous observation of the foot pressure center (COP). By recording the postural oscillations of the body as a function of time, detailed information about the postural system is obtained'}, {'measure': 'Pressure Pain-Threshold Measurements with Algometer', 'timeFrame': '5 Minutes', 'description': 'It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure. The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.'}, {'measure': 'Electrogoniometer', 'timeFrame': '5 Minutes', 'description': 'It is an evaluation tool used to record the objective measurement of joint range of motion.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '1 Minutes', 'description': 'Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '10 Minutes', 'description': 'The Oswestry Disability Index is a commonly used outcome measure to detect perceived disability in patients with low back pain. It consists of 10 questions, each of which is scored between 0 and 5, assessing the degree of pain, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change in pain. The minimum score obtained from the scale is 0, and the maximum score is 50. 0-4 points as no disability, 5-14 points as mild, 15-24 points as moderate, 25-34 points as severe and 35-50 points as complete functional disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Chronic Low Back Pain', 'Exercise', 'Lumbal Disc Herniation', 'Manual Therapy', 'Mulligan Mobilization'], 'conditions': ['Chronic Low-back Pain', 'Lumbal Disc Herniation', 'Imbalance']}, 'descriptionModule': {'briefSummary': 'This study was aimed to investigate the effectiveness of mulligan mobilization technique on balance, pain and functionality in patients with chronic low back pain and to compare it with exercise.37 patients aged between 18-65 who applied to Fındıkzade Medipol Hospital were included in the study. The individuals participating in the study were divided into two groups, 18 control and 19 mulligan groups, according to the randomization table. The intervention was performed 3 times a week for 4 weeks. Conventional physiotherapy and exercise program accompanied by a physiotherapist were applied to the control group, and conventional physiotherapy and mulligan mobilization technique were applied to the mulligan group. Conventional physiotherapy methods included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS), and hotpack. The patients were evaluated with TecnoBody Static Balance Device, algometer, electrogoniometer, visual analog scale, Oswestry Low Back Pain Disability Questionnaire before and after the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experiencing non-specific chronic low back pain for more than 3 months\n* The diagnosis has been confirmed by the Health Board Report\n* Be over 18 years old\n* Be younger than 65 years old\n* Pain of at least 2 severity according to VAS\n* Voluntarily agree to participate in the study\n\nExclusion Criteria:\n\n* Previous lumbar trauma or operation\n* Long-term use of corticosteroids\n* Cancer\n* Pregnancy\n* Osteoporosis\n* Systemic Diseases\n* Spinal Deformities\n* Lumbal Stenosis\n* Ankylozone Spondylitis\n* Spondylolisthesis\n* Spinal Deformities\n* Lumbal Stenosis'}, 'identificationModule': {'nctId': 'NCT05334394', 'briefTitle': 'The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'The Effect of Mulligan Mobilization Technique on Balance, Pain and Functionality in Patients With Chronic Low Back Pain', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-2868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mulligan Group', 'interventionNames': ['Other: Mulligan Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'interventionNames': ['Other: Exercise Therapy']}], 'interventions': [{'name': 'Mulligan Technique', 'type': 'OTHER', 'description': "Mulligan suggested that injuries or sprains can cause a minor positional error in a joint, thereby causing limitations in physiological movement. Unique to this concept is mobilization of the spine while weight bearing and directing the mobilization parallel to the spinal facet planes. Although it includes various mobilization techniques, one of the most important techniques, motion co-mobilization, is the SNAG's technique, which includes the application of accessory passive gliding to the lumbar vertebra while the patient performs active movement simultaneously.", 'armGroupLabels': ['Mulligan Group']}, {'name': 'Exercise Therapy', 'type': 'OTHER', 'description': 'Exercise is recommended by physical therapists for most chronic low back pain patients.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'state': 'Fındıkzade', 'country': 'Turkey (Türkiye)', 'facility': 'Fındıkzade Medipol Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Kübra Bali, Licenced', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medipol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kubra Bali', 'investigatorAffiliation': 'Medipol University'}}}}