Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT05855993
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Symptom Severity Scale (SSS)', 'timeFrame': '4 weeks', 'description': 'Measure the severity of symptom. Scores mild, moderat, severe \\& very severe'}, {'measure': 'Functional Status Scale (FSS)', 'timeFrame': '4 weeks', 'description': 'Used to measure the functional disability of hand. Scoring - No difficulty, mild difficulty, moderate difficulty \\& cant do at all'}], 'primaryOutcomes': [{'measure': 'Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)', 'timeFrame': '4 Week', 'description': 'To calculate score, add together the scores for all 11 questions in part 1, to give a total out of 55.(11)'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale(VAS)', 'timeFrame': '4 weeks', 'description': 'To measure the pain response before and after treatment as no pain (0)severe pain (10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTS', 'Functional Status Scale', 'Non Invasive Methods'], 'conditions': ['Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '35817691', 'type': 'BACKGROUND', 'citation': 'Ashour AA, Yehia RM, ElMeligie MM, Hanafy AF. Effectiveness of high intensity laser therapy on pain, grip strength and median nerve conductivity in pregnant women with carpal tunnel syndrome: A randomized controlled trial. J Hand Ther. 2023 Jul-Sep;36(3):536-545. doi: 10.1016/j.jht.2022.03.005. Epub 2022 Jul 8.'}, {'pmid': '31267198', 'type': 'BACKGROUND', 'citation': 'Oliveira GAD, Bernardes JM, Santos ES, Dias A. Carpal tunnel syndrome during the third trimester of pregnancy: prevalence and risk factors. Arch Gynecol Obstet. 2019 Sep;300(3):623-631. doi: 10.1007/s00404-019-05233-6. Epub 2019 Jul 2.'}, {'pmid': '32063607', 'type': 'BACKGROUND', 'citation': 'Keskin Y, Kilic G, Taspinar O, Posul SO, Halac G, Eren F, Erol E, Urkmez B, Aydin T. Effectiveness of home exercise in pregnant women with carpal tunnel syndrome: Randomized Control Trial. J Pak Med Assoc. 2020 Feb;70(2):202-207. doi: 10.5455/JPMA.1846.'}, {'pmid': '30967707', 'type': 'BACKGROUND', 'citation': 'Bartkowiak Z, Eliks M, Zgorzalewicz-Stachowiak M, Romanowski L. The Effects of Nerve and Tendon Gliding Exercises Combined with Low-level Laser or Ultrasound Therapy in Carpal Tunnel Syndrome. Indian J Orthop. 2019 Mar-Apr;53(2):347-352. doi: 10.4103/ortho.IJOrtho_45_17.'}, {'type': 'BACKGROUND', 'citation': 'Nageswari C, Meena N, Devi TR. A Non Invasive Approach to Prevent Carpel Tunnel Syndrome of IT Women during Pregnancy'}, {'type': 'BACKGROUND', 'citation': 'VAIDYA S, NARIYA D. Effect of Neural Mobilisation Versus Nerve and Tendon Gliding Exercises in Carpal Tunnel Syndrome: A Randomised Clinical Trial. Journal of Clinical & Diagnostic Research. 2020;14(6)'}, {'pmid': '29426574', 'type': 'BACKGROUND', 'citation': 'Sim SE, Gunasagaran J, Goh KJ, Ahmad TS. Short-term clinical outcome of orthosis alone vs combination of orthosis, nerve, and tendon gliding exercises and ultrasound therapy for treatment of carpal tunnel syndrome. J Hand Ther. 2019 Oct-Dec;32(4):411-416. doi: 10.1016/j.jht.2018.01.004. Epub 2018 Feb 13.'}, {'pmid': '28395984', 'type': 'BACKGROUND', 'citation': 'Wolny T, Saulicz E, Linek P, Shacklock M, Mysliwiec A. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial. J Manipulative Physiol Ther. 2017 May;40(4):263-272. doi: 10.1016/j.jmpt.2017.02.004. Epub 2017 Apr 8.'}, {'pmid': '20532100', 'type': 'BACKGROUND', 'citation': 'Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.'}, {'pmid': '22915047', 'type': 'BACKGROUND', 'citation': 'Price DD, Staud R, Robinson ME. How should we use the visual analogue scale (VAS) in rehabilitation outcomes? II: Visual analogue scales as ratio scales: an alternative to the view of Kersten et al. J Rehabil Med. 2012 Sep;44(9):800-1; discussion 803-4. doi: 10.2340/16501977-1031. No abstract available.'}, {'pmid': '28825339', 'type': 'BACKGROUND', 'citation': 'Bougea A, Zambelis T, Voskou P, Katsika PZ, Tzavara C, Kokotis P, Karandreas N. Reliability and Validation of the Greek Version of the Boston Carpal Tunnel Questionnaire. Hand (N Y). 2018 Sep;13(5):593-599. doi: 10.1177/1558944717725379. Epub 2017 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'To study the effects of Neural Glides with and without using therapeutic ultrasound and functional status in pregnant computer workers with CTS', 'detailedDescription': "Carpal Tunnel Syndrome is a median nerve compression and results in significant discomfort and pain, daily living activity limitation, loss of sleep and work disability. Carpal tunnel Syndrome is more common in pregnancy because in pregnancy prolactin hormone increase the fluid retention in extra capsule and results in soft tissue swelling. Several therapeutically treatments have been advocated for the carpal tunnel syndrome including Mobilizations, nerve gliding, tendon gliding, Ultrasound, icing, Massaging. Women experience pregnancy several times, and if they acquire Carpal tunnel syndrome, invasive treatments cannot be used, the probability of reoccurrence of Carpal tunnel syndrome in the next pregnancy with higher intensity. Use of non-invasive treatment methods are more beneficial. Carpal tunnel syndrome very common nowadays as most of the population is involved in computer work by some means especially the computer working ladies who always use the conventional mouse and key board for their work. Pregnant Women diagnosed with Carpal Tunnel syndrome and are computer working would be selected for this study. Diagnostic criteria would be positive Tinel's and Phalen's. The subjects will be divided into two groups. Group A (Experimental) and group B (Control). Group A will perform with nerve glides with therapeutic ultrasound. The control group does only exercise program (tendon and nerve gliding exercises). Both groups are assessed by outcome measures pre and post interventions. Pain symptoms is measured with the help of Visual Analogue Scale, The Boston Carpal Tunnel questionnaire form will administer for the patient evaluation Functional Status Scale and Symptom Severity Scale."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nThird trimester Tinel's sign positive Phalen test positive Pregnant women with pain and numbness in wrist and fingers Women with tingling sensation in the wrist Nocturnal parasthesia in wrist and fingers\n\nExclusion Criteria:\n\nInflammatory joint disease Age above 35 years Wrist bone fractures Hand surgery Diabetes Gout Autoimmune disease Person with rheumatoid arthritis Any other abnormalities"}, 'identificationModule': {'nctId': 'NCT05855993', 'briefTitle': 'Neural Glides With and Without Therapeutic Ultra Sound on in Pregnant Computer Workers With Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Neural Glides With and Without Therapeutic Ultra Sound on Pain Symptom Severity and Functional Status in Pregnant Computer Workers With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/23/0520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve Glide Exercise with Ultra Sound', 'interventionNames': ['Other: Nerve Glide Exercise with Ultra Sound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve Glide Exercise without Ultra Sound', 'interventionNames': ['Other: Nerve Glide Exercise without Ultra Sound']}], 'interventions': [{'name': 'Nerve Glide Exercise with Ultra Sound', 'type': 'OTHER', 'description': 'A brief demonstration will be given to perform the nerve glides exercises to both group. The duration of exercise programmed is 15 minutes every 3 to 5 times per day for 4 weeks. Group A will perform exercise with ultrasound', 'armGroupLabels': ['Nerve Glide Exercise with Ultra Sound']}, {'name': 'Nerve Glide Exercise without Ultra Sound', 'type': 'OTHER', 'description': 'Group B will perform exercise for 10 minutes every 3 to 5 times per day without ultrasound.', 'armGroupLabels': ['Nerve Glide Exercise without Ultra Sound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Hafiza Mehjabeen, PhD', 'role': 'CONTACT', 'email': 'hafiza.mehjabeen@riphah.edu.pk', 'phone': '03026577666'}, {'name': 'Sameen Akhter, WHPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hafiza Mehjabeen, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jinnah Hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Imran Amjad, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Hafiza Mahjabeen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}