Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT04515966
Status:
UNKNOWN
Last Update Posted:
2021-09-09
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Ultrasound-guided Steroid Injection With Wrist Splint in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-08-13', 'lastUpdatePostDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carpal tunnel syndrome, Change in symptom severity from baseline to 6 weeks', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS). 11 questions with score ranging from 1 (Normal) to 5 (Very Serious). Composite score range 11-55. The score mapping is as follows: 11: Asymptomatic; 12 to 22: Mild; 23 to 33: Moderate; 34 to 44: Severe; 45-55: Very Severe.\n\nQuestionnaire is administered by an investigator.'}, {'measure': 'Carpal tunnel syndrome, Change in functional status from baseline to 6 weeks', 'timeFrame': 'Baseline, 6 weeks', 'description': 'Boston Carpal Tunnel Questionnaire (BCTQ) Functional Status Scale (FSS). 8 questions with score ranging from 1 (No Difficulty) to 5 (Unable to Perform). Composite score range 8-40. The score mapping is as follows: 8: Asymptomatic; 9 to 16: Mild; 17 to 24: Moderate; 25 to 32: Severe; 33-40: Very Severe.\n\nQuestionnaire is administered by an investigator.'}, {'measure': 'Carpal tunnel syndrome, Change in pain assessment from baseline to 6 weeks', 'timeFrame': 'Baseline, 6 weeks', 'description': "Visual Analog Scale (VAS). A visual pain scale measures a patient's pain intensity. Scale ranging from 0 (No Pain) to 10 (Unbearable Pain) characterized by depictions of facial expressions. The score mapping is as follows: 0: No Pain; 1 to 3: Mild Pain; 4 to 6: Moderate Pain; 7 to 10: Severe Pain\n\nAssessment is performed by an investigator."}], 'secondaryOutcomes': [{'measure': 'Change in Median Nerve Dimensions', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 6 months, 1 year', 'description': 'The median nerve dimensions at the carpal tunnel inlet is measured by high-resolution ultrasound. The diameter is measured in millimeters, and cross-sectional area calculated in square millimeters'}, {'measure': 'Carpal tunnel syndrome, Change in symptom severity at 12 weeks, 6 months, 1 year', 'timeFrame': '12 weeks, 6 months, 1 year', 'description': 'Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS). 11 questions with score ranging from 1 (Normal) to 5 (Very Serious). Composite score range 11-55. The score mapping is as follows: 11: Asymptomatic; 12 to 22: Mild; 23 to 33: Moderate; 34 to 44: Severe; 45-55: Very Severe.\n\nQuestionnaire is administered by an investigator.'}, {'measure': 'Carpal tunnel syndrome, Change in functional status at 12 weeks, 6 months, 1 year', 'timeFrame': '12 weeks, 6 months, 1 year', 'description': 'Boston Carpal Tunnel Questionnaire (BCTQ) Functional Status Scale (FSS). 8 questions with score ranging from 1 (No Difficulty) to 5 (Unable to Perform). Composite score range 8-40. The score mapping is as follows: 8: Asymptomatic; 9 to 16: Mild; 17 to 24: Moderate; 25 to 32: Severe; 33-40: Very Severe.\n\nQuestionnaire is administered by an investigator.'}, {'measure': 'Carpal tunnel syndrome, Change in pain perception at 12 weeks, 6 months, 1 year', 'timeFrame': '12 weeks, 6 months, 1 year', 'description': "Visual Analog Scale (VAS). A visual pain scale measures a patient's pain intensity. Scale ranging from 0 (No Pain) to 10 (Unbearable Pain) characterized by depictions of facial expressions. The score mapping is as follows: 0: No Pain; 1 to 3: Mild Pain; 4 to 6: Moderate Pain; 7 to 10: Severe Pain\n\nAssessment is performed by an investigator."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wrist splint', 'steroid injection', 'median nerve ultrasound'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '21386049', 'type': 'BACKGROUND', 'citation': 'Klauser AS, Halpern EJ, Faschingbauer R, Guerra F, Martinoli C, Gabl MF, Arora R, Bauer T, Sojer M, Loscher WN, Jaschke WR. Bifid median nerve in carpal tunnel syndrome: assessment with US cross-sectional area measurement. Radiology. 2011 Jun;259(3):808-15. doi: 10.1148/radiol.11101644. Epub 2011 Mar 8.'}, {'pmid': '21845577', 'type': 'BACKGROUND', 'citation': 'Demircay E, Civelek E, Cansever T, Kabatas S, Yilmaz C. Anatomic variations of the median nerve in the carpal tunnel: a brief review of the literature. Turk Neurosurg. 2011;21(3):388-96. doi: 10.5137/1019-5149.JTN.3073-10.1.'}, {'pmid': '22674243', 'type': 'BACKGROUND', 'citation': 'Karadas O, Tok F, Akarsu S, Tekin L, Balaban B. Triamcinolone acetonide vs procaine hydrochloride injection in the management of carpal tunnel syndrome: randomized placebo-controlled study. J Rehabil Med. 2012 Jun;44(7):601-4. doi: 10.2340/16501977-0990.'}, {'pmid': '21072732', 'type': 'BACKGROUND', 'citation': 'Tagliafico A, Bodner G, Rosenberg I, Palmieri F, Garello I, Altafini L, Martinoli C. Peripheral nerves: ultrasound-guided interventional procedures. Semin Musculoskelet Radiol. 2010 Nov;14(5):559-66. doi: 10.1055/s-0030-1268066. Epub 2010 Nov 11.'}, {'pmid': '30343858', 'type': 'BACKGROUND', 'citation': 'Chesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, Myers HL, Oppong R, Rathod-Mistry T, van der Windt DA, Hay EM, Roddy E. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-1433. doi: 10.1016/S0140-6736(18)31572-1.'}, {'pmid': '27751557', 'type': 'BACKGROUND', 'citation': 'Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.'}, {'pmid': '25378457', 'type': 'BACKGROUND', 'citation': 'Middleton SD, Anakwe RE. Carpal tunnel syndrome. BMJ. 2014 Nov 6;349:g6437. doi: 10.1136/bmj.g6437. No abstract available.'}, {'pmid': '29499823', 'type': 'BACKGROUND', 'citation': 'Calandruccio JH, Thompson NB. Carpal Tunnel Syndrome: Making Evidence-Based Treatment Decisions. Orthop Clin North Am. 2018 Apr;49(2):223-229. doi: 10.1016/j.ocl.2017.11.009. Epub 2018 Feb 1.'}, {'pmid': '25177448', 'type': 'BACKGROUND', 'citation': 'Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.'}, {'pmid': '19782873', 'type': 'BACKGROUND', 'citation': 'Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA. Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial. Lancet. 2009 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.'}, {'pmid': '28901660', 'type': 'BACKGROUND', 'citation': 'So H, Chung VCH, Cheng JCK, Yip RML. Local steroid injection versus wrist splinting for carpal tunnel syndrome: A randomized clinical trial. Int J Rheum Dis. 2018 Jan;21(1):102-107. doi: 10.1111/1756-185X.13162. Epub 2017 Sep 13.'}, {'pmid': '27696773', 'type': 'BACKGROUND', 'citation': 'Evers S, Bryan AJ, Sanders TL, Selles RW, Gelfman R, Amadio PC. Effectiveness of Ultrasound-Guided Compared to Blind Steroid Injections in the Treatment of Carpal Tunnel Syndrome. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1060-1065. doi: 10.1002/acr.23108. Epub 2017 Jun 8.'}, {'pmid': '26962518', 'type': 'BACKGROUND', 'citation': 'Khosrawi S, Emadi M, Mahmoodian AE. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial. Adv Biomed Res. 2016 Feb 8;5:16. doi: 10.4103/2277-9175.175902. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'Carpal Tunnel Syndrome (CTS) is caused by compression of a nerve called the median nerve as it travels through a narrow tunnel within the wrist on its way to the hand. Compression of the median nerve causes numbness, tingling, pain and weakness of the hand and fingers. CTS is usually treated with rest or a change in the activity level. It can also be treated with a splint that limits bending of the hand and wrist. Other treatments include a steroid injection near the median nerve. Surgery can be performed if the symptoms are severe or persistent.\n\nCompression of the median nerve can cause swelling that may be observed with ultrasound of the wrist. Ultrasound can also be used to help guide the needle to inject the steroid solution in close proximity to the median nerve while avoiding injury to the nerve.\n\nThe investigators plan to compare the effectiveness of a splint and an ultrasound-guided steroid injection in the treatment of mild to moderate CTS. Individuals with CTS who agree to participate, will be randomly assigned to two groups. One group will be treated with a splint and the other with a steroid injection performed under ultrasound guidance. The severity of CTS symptoms will be determined prior to beginning the study and also at 6 weeks, 3 months, 6 months and 1 year following each of the two treatment interventions. The median nerve size (diameter) will be measured in all participants prior to beginning the study and also following both treatment interventions at 6 weeks, 3 months, 6 months and 1 year.\n\nAt the conclusion of the study, the investigators will determine which of the two treatments, splint or steroid injection, is more effective in alleviating CTS symptoms. The investigators will also determine if either or both treatments result in a change in swelling of the median nerve as measured by ultrasound.', 'detailedDescription': 'The purpose of the study is to determine which of two commonly used therapeutic interventions for the treatment of carpal tunnel syndrome (CTS), steroid injection or wrist splint, is more effective in alleviating symptoms. The protocol has been approved by the Medical Research Committee and by the Institutional Review Board, Mercy Health, Youngstown.\n\nThe steroid injection will be administered under ultrasound guidance to ensure proper placement of the needle in close proximity to the median nerve within the carpal tunnel and to minimize the risk of direct trauma to the nerve.\n\nCandidates for the study will be individuals with CTS presenting to primary care offices located in the Boardman, Ohio area. Following a detailed explanation of the study purpose and protocol, those individuals who agree to participate will be asked to sign an informed consent form.\n\nA complete history and physical examination will be performed on all participants to confirm the diagnosis. Additionally, baseline ultrasound measurement of the median nerve cross-sectional area within the carpal tunnel will be performed on all participants. The diagnosis of CTS will be made on clinical grounds, and the CTS-6 evaluation tool will also be used in the diagnostic evaluation. A score above 12 will be considered consistent with CTS. Participants with moderately severe CTS will undergo a nerve conduction study to confirm the diagnosis and exclude early signs of denervation which may require surgical decompression.\n\nParticipants will be randomized into two groups of thirty-five patients each; those in group A will undergo ultrasound-guided steroid injection and those in group B will be asked to wear a standard carpal tunnel splint. Participants will be randomly assigned to either intervention group with the use of a computer-generated random sequence of numbers from 1 to 70. The primary investigator (Roy Morcos) will be responsible for maintaining confidential records in a secure location.\n\nThe injections will be performed by Dr. Morcos and Dr. Dhungana. Dr. Morcos received training in ultrasonography during a fellowship program and has published on the subject. He has been performing ultrasound examinations and injections for the past 35 years. Dr. Dhungana is an orthopedic surgeon with expertise in carpal tunnel steroid injections.\n\nWith the participant seated and the forearm supinated, the wrist is slightly dorsiflexed. The median nerve is identified with real-time ultrasonography and its cross-sectional area measured. Injection near the median nerve within the carpal tunnel is performed under aseptic technique and ultrasound guidance, using a 25-gauge needle to minimize discomfort.\n\nGroup A: A mixture of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine will be injected into the carpal tunnel under ultrasound guidance in close proximity to the median nerve. After completion of the injection, the distal carpal tunnel is scanned to ensure even injectate distribution within the distal aspect of the carpal tunnel.\n\nGroup B: Patients in this group will be advised to wear a standard carpal tunnel splint with the hand in neutral position. The splint will be provided to all participants. They will be advised to wear it during the night and most of the time during day.\n\nThe median nerve cross-sectional area is measured in all patients at baseline, 6 weeks and 3 months following interventions.\n\nFollow-up is scheduled 6 weeks, 3 months, 6 months and one year. At each follow-up visit, clinical evaluation is obtained using the BCTQ score, which determines the degree of symptomatic severity and functional recovery. A visual analog scale (VAS) for pain, 0 for no pain and 10 for severe unbearable pain, will also be obtained. Follow-up will continue for a year including history and physical examination.\n\nDescriptive statistics will be used to characterize the data using the mean, standard deviation, and median. For parameter with subset scales and values, box and whisker plots will be used to show patterns of parameter behavior. Where levels of measures are appropriate, independent samples t-tests are performed to compare outcomes of each intervention. Where appropriate, a non-parametric test such as the Mann-Whitney U test, is used to assess differences of parameter values both over periods of follow up and between two treatments.\n\nThe measures of effect are as follows: Pain, Symptom severity, Functional disability, Median nerve diameter, Median nerve cross sectional area. Three of the parameters are from arbitrary scales consisting of standard questionnaires. Two of the parameters are composite values derived from scores with differing weightings. Two anatomic measures are based on metric measurements obtained by ultrasound. All measures will be taken before treatment and at 6 weeks, 12 weeks, 6 months and 1 year. Based on an assumed BCTS Pain Score treatment effect of 1.5 with standard deviation of 3.0 with 2-sided α of 0.05 and a power of 0.87, the minimum required sample size in each study group is 32. Considering loss to follow-up over a period of one year, the investigators plan to recruit 70 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with typical symptoms of CTS, including nocturnal, postural, or usage-associated paresthesia of the hand\n* symptoms persisting for at least 3 months before the study\n* Patients with mild to moderate symptoms\n* no history of steroid injections in the past\n* no history of CT release surgery\n* and age 18 to 75.\n\nExclusion Criteria:\n\n* Thenar atrophy or muscle weakness\n* severe CTS\n* pregnancy\n* hypothyroidism\n* diabetes mellitus\n* chronic renal failure\n* rheumatoid arthritis\n* orthopedic or neurological disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome\n* history of distal radius fracture\n* anticoagulation\n* chronic use of systemic corticosteroids\n* known allergy to corticosteroids and local anesthetics.'}, 'identificationModule': {'nctId': 'NCT04515966', 'briefTitle': 'A Comparison of Ultrasound-guided Steroid Injection With Wrist Splint in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Health Ohio'}, 'officialTitle': 'Randomized Controlled Trial of Ultrasound-guided Steroid Injection Versus Wrist Splint in Patients With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '20-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided steroid injection', 'description': 'Participants with CTS who meet the inclusion criteria are randomized to two groups. One group (or arm) will receive an ultrasound-guided steroid injection in the vicinity of the median nerve within the carpal tunnel. A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine is injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.', 'interventionNames': ['Drug: Methylprednisolone Injection [Solu-Medrol]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wrist splint', 'description': 'Participants in this arm are treated with a wrist splint.', 'interventionNames': ['Device: wrist splint']}], 'interventions': [{'name': 'Methylprednisolone Injection [Solu-Medrol]', 'type': 'DRUG', 'otherNames': ['Lidocaine, 1% solution'], 'description': 'A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine will be injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.', 'armGroupLabels': ['Ultrasound-guided steroid injection']}, {'name': 'wrist splint', 'type': 'DEVICE', 'description': 'A standard wrist splint', 'armGroupLabels': ['Wrist splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44512', 'city': 'Boardman', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roy Morcos, MD', 'role': 'CONTACT'}], 'facility': 'St. Elizabeth Boardman Family Medicine', 'geoPoint': {'lat': 41.02423, 'lon': -80.66285}}], 'centralContacts': [{'name': 'Roy N. Morcos, M.D.', 'role': 'CONTACT', 'email': 'roy_morcos@mercy.com', 'phone': '(330)729-8700'}], 'overallOfficials': [{'name': 'Roy N. Morcos, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bon Secours Mercy Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Health Ohio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Family and Community Medicine', 'investigatorFullName': 'Roy Morcos', 'investigatorAffiliation': 'Mercy Health Ohio'}}}}