Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 8:28 AM
Study NCT ID:
NCT04292795
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2020-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058923', 'term': 'Medial Tibial Stress Syndrome'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-03-01', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'the outcome will be assessed at baseline (day zero).', 'description': 'The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome'}, {'measure': 'Post-Numeric Pain Rating Scale (NPRS)', 'timeFrame': 'the outcome will be assessed at end of 4th week', 'description': 'The outcome measure suitable for evaluating the severity of pain in medial tibial stress syndrome'}, {'measure': 'Pre-Medial Tibial Stress Syndrome Score', 'timeFrame': 'the outcome will be assessed at baseline (day zero)', 'description': 'The outcome measure suitable for evaluating the severity of medial tibial stress syndrome'}, {'measure': 'Post-Medial Tibial Stress Syndrome Score', 'timeFrame': 'the outcome will be assessed after the 4 weeks.', 'description': 'The outcome measure suitable for evaluating the severity of medial tibial stress syndrome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medial Tibial Stress Syndrome', 'Pain', 'Pain Syndrome', 'Cadets'], 'conditions': ['Medial Tibial Stress Syndrome']}, 'referencesModule': {'references': [{'pmid': '15090396', 'type': 'RESULT', 'citation': 'Yates B, White S. The incidence and risk factors in the development of medial tibial stress syndrome among naval recruits. Am J Sports Med. 2004 Apr-May;32(3):772-80. doi: 10.1177/0095399703258776.'}]}, 'descriptionModule': {'briefSummary': 'Medial tibial stress syndrome (MTSS) also known as shin splints or tibial periostitis is a common injury in athletes and soldiers/cadets with incidences ranging between 4% and 35% in these populations . It is characterized by pain in the middle and lower end of tibia; the pain is usually elicited by practicing sports or other physical activities. The criteria for diagnosis for MTSS were established by Yates and White. Although the prognosis of MTSS is usually benign, it can evolve to chronicity and be disabling.\n\nSeveral studies have demonstrated the effects of different medical treatment in athletes and cadets with MTSS. Study will correspond to the demonstration of treatment options for medial tibial stress syndrome that lie in the domain of Physical Therapy.\n\nTherapeutic Ultrasound and Shortwave Diathermy.', 'detailedDescription': 'Primary objective of the study includes:\n\n1. To determine the effect of Shortwave Diathermy on Medial Tibial Stress Syndrome among military cadets.\n2. To determine the effect of Therapeutic Ultrasound on Medial Tibial Stress Syndrome among military cadets.\n3. To compare the effects of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome among military cadets.\n\nstudy hypothesis is "Shortwave diathermy and Therapeutic Ultrasound are equally effective in Medial Tibial Stress Syndrome among military cadets.".\n\nStudy Design : Randomized Control trial Study Settings is Pakistan Military Academy Abbottabad. Sample Size: The sample size calculation is done through epitool to obtain a sample size ratio 1:1 for both treatment groups with Power of 0.8, Confidence interval of 0.95 and Variance = 5.\n\nMean of experimental group was 2.17 and mean of control group was 4.26 taken from the parent article.\n\nResults obtained from epitool:\n\nTotal sample size: 36 Sample size per group: 18(each group) Sampling Technique: Non-probability Purposive Sampling- subjects will be recurited into the groups through sealed enveloped method.\n\nWork Plan/Timeline for Participants:\n\nTimeline for the participants will be one month after the approval of IRB form.\n\nFollow ups:\n\nThere will be 2 follow ups per week for a period of 4 weeks.\n\nStatistical Analysis:\n\nData will be analyzed on Statistical Package for Social Sciences (SPSS) version 21.\n\nDescriptive Results:\n\n* Quantitative data will be interpreted in terms of means and standard deviation whereas qualitative data will be presented in the form of frequencies and percentages.\n* Quantitative data will be represented in form of histogram whereas qualitative data is shown in the form of bar charts and graphs.\n\nInterferential Results:\n\n* Data will be assessed for its normality by applying Shapiro-Wilk test and its value of 0.05 or lesser than that shows that the data is normally distributed at baseline and at the end of treatment.\n* Parametric test will be used for normally distributed data whereas non parametric test would be applied for skewed sample or away from normality data.\n* For comparison between two groups, Independent T Test (parametric) or Mann-Whitney Test(non-parametric) will be used both a baseline and at the end of sessions.\n* For within the group comparison at intervals (baseline and post treatment), Pared T test (parametric) or Wilcoxon Rank Test (non-parametric) will be applied.\n\nADVERSE/SERIOUS ADVERSE EFFECTS / POTENTIAL HAZARDS:\n\nNo adverse effects are present in this study. Onsite clinical arrangements will be made available for subjective and objective assessment and for the treatment protocol as well. For this purpose portable modalities will be used which will be easy to transfer and operate. The total expenses required will be provided by the students themselves\n\nNo potential risk present to the participants or community as a whole\n\nPOTENTIAL BENEFIT TO THE PARTICIPANTS OR COMMUNITY AS WHOLE\n\n1. Awareness will be provided regarding MTSS among community.\n2. Long term complications leading to physical limitations and disability will be prevented.\n3. Awareness regarding Physical Therapy treatment for MTSS will be provided'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '24 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 19-24 years\n2. Gender: Male\n3. Cadets diagnosed with Medial tibial stress syndrome according to Yates and White Criteria(3).\n\nExclusion Criteria:\n\n1. Individuals having stress fractures or history of stress fractures.\n2. Local infection or osteomyelitis.\n3. Tumor in assessment region.\n4. Compartment syndrome.\n5. Musculoskeletal problems or other comorbidities.'}, 'identificationModule': {'nctId': 'NCT04292795', 'briefTitle': 'Effect of Shortwave Diathermy and Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets', 'organization': {'class': 'OTHER', 'fullName': 'Shifa Clinical Research Center'}, 'officialTitle': 'Effect of Shortwave Diathermy Versus Therapeutic Ultrasound on Medial Tibial Stress Syndrome Among Military Cadets', 'orgStudyIdInfo': {'id': 'Applied_for_IRB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Intervention: Shortwave Diathermy Frequency: 27.12 MHz Time Duration: 10min Duration of Treatment: 4 weeks. Sessions per Week: 2 sessions per week', 'interventionNames': ['Device: Short wave diathermy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Intervention: Therapeutic Ultrasound Frequency: 1-3MHz Intensity: 0.2-1W/cm2 Time Duration: 10mins Duration of Treatment: 4 weeks Sessions per Week: 2 sessions per week', 'interventionNames': ['Device: Therapeutic Ultrasound']}], 'interventions': [{'name': 'Therapeutic Ultrasound', 'type': 'DEVICE', 'description': 'The Intervention will be provided according to the set protocols used in previous literature.', 'armGroupLabels': ['Group B']}, {'name': 'Short wave diathermy', 'type': 'DEVICE', 'description': 'The Intervention will be provided according to the set protocols used in previous literature.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbottābād', 'state': 'KPK', 'country': 'Pakistan', 'contacts': [{'name': 'IRB Shifa', 'role': 'CONTACT', 'email': 'irbshifa@shifa.com.pk', 'phone': '0092518463075'}, {'name': 'Dr. Tahir Ramzan, DPT, MS-CPPT', 'role': 'CONTACT', 'phone': '03015515598'}], 'facility': 'Military Academy'}], 'centralContacts': [{'name': 'Tahir Ramzan, DPT', 'role': 'CONTACT', 'email': 'drtahirramzan@gmail.com', 'phone': '923015515598'}], 'overallOfficials': [{'name': 'Tahir Ramzan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shifa Tameer-e-Millat University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shifa Clinical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Dr. Tahir Ramzan', 'investigatorAffiliation': 'Shifa Clinical Research Center'}}}}