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IRCT20200824048503N1 IRCT 2020-09-25 Iran University of Medical Sciences Comparison of the effect of shock wave therapy and steroid injection in carpal tunnel syndrome Comparison of the effect of shockwave therapy and steroid injection on sonographic and electrodiagnostic findings in carpal tunnel syndrome 2020-12-03 anticipated 60 Complete https://irct.ir/trial/50823 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After sampling, which will be easy as sampling, patients will be randomly (using random blocking method) in one of the two groups of 40 mg triamcinolone topical injection under the guidance of sonography and shock wave treatment. N/A Carpal tunnel syndrome. Intervention 1: Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection Also use a wrist splint for 6 weeks. Intervention 2: Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent. Also use a wrist splint for 6 weeks. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: Access period starts from the winter of 1399 To whom: For researchers working in academic and scientific institutions Conditions: No analysis is allowed on the delivered data. Where to obtain: Mail How to obtain: Request via email Comments:
public Hawre Morovati
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) 8739118631 +98 21 8214 1229 morovati.hawre@gmail.com Iran University of Medical Sciences scientific Hawre Morovati
Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) 8739118631 +98 21 8214 1229 morovati.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Referrals of patients with signs and symptoms of carpal tunnel syndrome (including pain and sensory disturbances in the area of the median nerve) Patients with mild to moderate carpal tunnel syndrome according to electrodiagnostic criteria 18 years no limit Both Severe carpal tunnel syndrome (based on electrodiagnosis data). Symptoms of atrophy of Tanar area Contraindications to corticosteroid injections (including allergy to corticosteroids and symptoms of skin infection at the injection site, local abscess at the injection site, patients with immunodeficiency, phobia to needles) Diseases that mimic the symptoms of CTS, such as polyneuropathy, cervical radiculopathy, thoracic outlet syndrome, Surgical treatment or topical injection in the last six months Neoplastic or traumatic origin of pain and fracture of wrist bones Age under 18 years G56.0 Carpal tunnel syndrome Treatment - Drugs Treatment - Drugs Intervention group: Forty mg triamcinolone topical injection group under ultrasound guidance with one injection Also use a wrist splint for 6 weeks Intervention group: Radial shock wave treatment group, Each patient in the Wave Radial shock treatment group receives two rounds of treatment one week apart with the characteristics of intensity, frequency, number of shocks and the type of device: 2 Bar, 6 Hz frequency, 2000 shocks TYPE OF MACHINE: (BTL-6000 SWT, RADIAL shockwave mode The probe is placed perpendicular to the patient's palm area between the distal crease of the wrist and Kaplan's cardinal line. Ultrasound gel is used as a binding agent. Also use a wrist splint for 6 weeks Electrodiagnostic criteria in the study. Timepoint: For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months. Method of measurement: Electro-diagnostic assessment will conduct with Natus (Synergy ultrapro S100) device by a physical medicine specialist for all patients. The diagnostic criteria of Carpal Tunnel Syndrome based on electrodiagnostic findings included: Distal latency of median sensory nerve action potential (SNAP) of third finger <3.6 and distal latency of median compound muscle action potential(CMAP) of abductor pollicis brevis (APB) muscle <4.2. If only the SNAP distal latency was long, patient had mild CTS, but if both SNAP and CMAP distal latency were long and denervation was not observed in electromyography of abductor pollicis brevis, it was moderate Carpal Tunnel Syndrome. The needle electromyography will be performed for other muscles of upper limbs to roll out other diagnosis for example : cervical radiculopathies , plexopathies and other median nerve entrapments. Sonographic Evaluation. Timepoint: For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months. Method of measurement: Median nerve Ultra Sound evaluation images will obtain by a physical medicine specialist for all patients . Images will collect on the same day as Electrodiagnostic testing by using a Hitachi ( 2015-JAPAN-Arietta v 60 j ) equipped with an 18–5 MHz linear array transducer. The median nerve will image in cross section at the distal wrist crease (carpal tunnel inlet) . The cross-sectional area (CSA) was calculated using the continuous trace method by outlining the perimeter just inside the hyperechoic epineurium. Three measurements will be made for each person and the average will be considered for analysis. Visual Analogue Scale. Timepoint: For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analogue Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months. Method of measurement: The visual scale for measuring pain intensity is a 10 cm ruler with the word painless written on the left end and the word "most severe pain" written on the right end. Continuity marks. Note that they only mark one point. The amount of pain was measured by the researcher using the Visual-Linear Pain Scale (VAS), which is standardized for measuring pain. The linear-visual pain measurement scale is divided from zero to ten as follows:0-1: No pain, 2-3: Low pain, 4-5: High pain, 6-7: Very bad pain, 8-9: Maximum pain, 10: unbearable pain. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ). Timepoint: For subjective evaluation of efficacy and comparison of corticosteroids with shock wave therapy method, two criteria Visual Analog Scale and Boston questionnaire and for objective evaluation of effectiveness and comparison of two methods, electrodiagnostic and sonographic criteria will be used in zero, 2 weeks, and It will be measured for 6 months. Method of measurement: The Boston questionnaire is self-applied and evaluates the severity of symptoms and the functional status of patients with carpal tunnel syndrome. The symptoms severity scale evaluates symptoms regarding severity, frequency, time and kind. The functional status scale evaluates how the syndrome affects daily life .Questions concerning symptoms severity scale are composed of 11questions addressing: pain intensity during daytime and nighttime, time of pain during the day, dormancy ,weakness, tingling sensation at night, frequency of that night tingling sensation, and skill. Each question has five answers numbered from 1 to 5, arranged in an increasing order of symptoms severity. Therefore, 1 means no symptoms, 2 mild symptoms, 3 moderate symptoms,4 intense symptoms, and 5 severe symptoms .Questions concerning functional status are composed of 8 questions, where each one corresponds to afunctional activity (writing, buttoning clothes, holding a book while reading, holding a telephone hang, housekeeping, opening a glass vial cap, carrying market bags, bathing and dressing). Iran University of Medical Sciences Approved 2020-07-14 Ethics Committee of Iran University of Medical Sciences Iran University of Medical sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)