Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-09 @ 1:52 PM
Study NCT ID:
NCT05580705
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2022-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'It will be a single blinded study and the outcome assessor will be blinded to the treatment group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Change in pain score will be measured at baseline, at the end of 1st week and 2nd week.', 'description': 'Pain Intensity will be measured by using Numeric Pain Rating Scale. Pain score range from 1-10, with 1 indicates least possible pain level and 10 is the worst pain level.'}, {'measure': 'Dynamic and Static Balance', 'timeFrame': 'Change in Balance score will be measured at baseline, at the end of 1st week and 2nd week.', 'description': 'Dynamic and static balance will be measured by using Berg Balance Scale. Its score range from 0 to 56, lower score represents more chances of losing balance and requirement of assistive measures.'}, {'measure': 'Level of Functional Disability', 'timeFrame': 'Change in Functional Disability score will be measured at baseline, at the end of 1st week and 2nd week', 'description': 'Functional Disability will be measured by using Revised Neuropathy Disability Score. The total score is 10 with higher score indicates more severity of disease.'}, {'measure': 'Patient Satisfaction Level', 'timeFrame': 'Change in Patient Satisfaction Level will be measured at baseline, at the end of 1st week and 2nd week.', 'description': 'Patient Satisfaction Level will be measured by the Patient Satisfaction Questionnaire. Total score is 90. and higher score towards maximum value indicates higher level of satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Vibration Therapy', 'Diabetic Neuropathy', 'Pain', 'Balance', 'Functional Disability', 'Patient satisfaction', 'Routine Physical Therapy'], 'conditions': ['Diabetic Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '40269358', 'type': 'DERIVED', 'citation': 'Bashir S, Jamil A, Ali S. Effects of vibration therapy with routine physical therapy on pain, balance, and functional disability in diabetic neuropathy patients: a randomised controlled trial. J Pak Med Assoc. 2025 Apr;75(4):534-539. doi: 10.47391/JPMA.20058.'}]}, 'descriptionModule': {'briefSummary': 'The study is aimed to determine the effects of sole-foot vibration therapy on pain intensity, static and dynamic balance, functional status and satisfaction to the intervention applied on patients with peripheral neuropathy due to type 2 diabetes mellitus.', 'detailedDescription': 'Peripheral Diabetic Neuropathy has disastrous effects on human body. It causes impairment which makes normal functioning and activity of daily life difficult. Vibration therapy improves neural mechano-sensitivity to promote movement and function.\n\nIn Pakistan, researches have been conducted only on Whole-body vibration and no data is available on foot-sole vibration therapy which is convenient to apply and appropriate for patients as there will be no fear of fall associated during treatment. Therefore, the aim of this study is to analyze the effects of vibration therapy, applied locally on foot, on pain management, balance adjustment, function and satisfaction to treatment in patients with diabetic neuropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of 40-75 years\n* Both male and female participants\n* On oral medicine for diabetes\n* HbA1C \\<8.5%, and controlled blood sugar in the last three months\n* Patients with \\< 6 years from diagnosis of diabetes\n* Diagnosed patient of peripheral neuropathy having type 2 diabetes by registered medical practitioner\n* Patient is able to stand on both feet.\n\nExclusion Criteria:\n\n* Systemic diseases such as advanced cardiovascular, renal, or hepatic diseases\n* Open wounds/ulcers on lower limb\n* Neurological illness that affects balance i.e. vertebral artery syndrome, Multiple Sclerosis, Parkinson's disease, Alzheimer's disease, Stroke and cerebral ataxia\n* Musculoskeletal problems such as leg length discrepancy, ankle sprain and severe osteoarthritis of knee and hip joints\n* Patients who have performed vibration therapy exercises prior to intervention\n* Patient under any antihypertensive drugs and blood pressure more than 160/95 mm hg"}, 'identificationModule': {'nctId': 'NCT05580705', 'briefTitle': 'Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effects of Vibration Therapy in Addition to Routine Physical Therapy on Pain, Balance, Functional Disability and Satisfaction in Patients With Diabetic Neuropathy', 'orgStudyIdInfo': {'id': 'Sajawal Bashir'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ROUTINE PHYSICAL THERAPY GROUP', 'description': 'This group will receive routine physical therapy including strength training intervention. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week.', 'interventionNames': ['Other: Routine Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'VIBRATION THERAPY', 'description': 'This group will receive routine physical therapy and vibration therapy. This protocol will be given for two weeks (6 sessions on alternate days, 3 sessions per week), outcomes will be measured at baseline, at the end of 1st week and 2nd week.', 'interventionNames': ['Other: Vibration Therapy']}], 'interventions': [{'name': 'Routine Physical Therapy', 'type': 'OTHER', 'description': 'The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises', 'armGroupLabels': ['ROUTINE PHYSICAL THERAPY GROUP']}, {'name': 'Vibration Therapy', 'type': 'OTHER', 'description': 'Vibration Therapy will include a vibration device of brand Manipol, model number RK-001. It has 360 degree off-centered axis with a frequency of 2500 times per minute. It will be applied on sole of the foot for about 15 mins.', 'armGroupLabels': ['VIBRATION THERAPY']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'The University of Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending on 36th month', 'ipdSharing': 'YES', 'description': 'Immediately after publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ayesha Jamil', 'investigatorAffiliation': 'University of Lahore'}}}}