4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome

Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome

Study Description
Brief Summary:
The objective of the present study is to compare the effectiveness of 5% dextrose, local corticosteroids injections and surgical release in patients with electrodiagnostically (EDx) mild to moderate carpal tunnel syndrome (CTS). The investigators hypothesize that in patients with mild to moderate CTS (1) local 5% dextrose injections is non-inferior to local corticosteroid injections at 12 months after treatment, and that (2) local 5% dextrose injections are of non-inferior effectiveness compared to surgical release at 6 months.

Condition or disease Intervention/treatment Phase
Peripheral Nervous System Diseases Nerve Compression Syndromes Carpal Tunnel Syndrome Drug: Corticosteroid vs. Dextrose Procedure: Corticosteroid or Dextrose vs. Surgery Not Applicable

Detailed Description:
Surgical release of the carpal ligament is a standard treatment of the median nerve entrapment at the wrist. Local corticosteroid injections are also an established alternative, particularly for EDx mild or moderate CTS, although majority of patients still needs surgical decompression within 1 year. Majority of studies concluded that after more than 6 months of treatment surgical decompression is better than local corticosteroids injections. Furthermore, corticosteroids also have a number of side effects, including crystal induced synovitis, tendon rupture, axon and myelin degeneration, soft tissue atrophy, skin thinning, steroid flare and hot flushes. Therefore, it would be very useful to have an effective alternative substance for injections, without these problems. Perineural injection of dextrose also seems to be a promising treatment for entrapment neuropathies. To date only two studies investigated the effectiveness of 5% dextrose injections in patients with CTS. Authors concluded that this is an effective treatment, that is for patients with mild or moderate CTS even more beneficial than corticosteroid injections at 6 months follow-up. It was suggested that perineural injection of 5% dextrose decreases neurogenic inflammation. As 5% dextrose has osmolarity similar to normal saline, this formulation seems particularly promising. These expectations were supported in studies including animals and humans reporting no harmful effects.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with bilateral CTS symptoms and EDx mild to moderate CTS will be included. In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance. In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
Masking: Double (Participant, Investigator)
Masking Description: Each of three investigators performing one part of diagnostic evaluation (history and focal neurologic examination, EDx and (3) ultrasonographic (US) studies) will be blinded for findings of other parts of evaluation. Furthermore, patients will be blinded for laterality of the injected substance.
Primary Purpose: Treatment
Official Title: Efficacy of Dextrose Injections, Corticosteroids Injections and Surgical Release for Treatment of the Carpal Tunnel Syndrome: a Prospective, Randomized, Double-blind Controlled Trial
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : September 1, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Corticosteroids vs. Dextrose
In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance.
 Drug: Corticosteroid vs. Dextrose
US guided injection of corticosteroid in one hand and 5% glucose in the other will be performed in accordance with randomization. In a syringe both substances will be diluted using 0.9% NaCl to a total injection volume of 6 ml. In-plane ulnar approach will be used to visualize the median nerve at the level of the pisiform bone. A standard 23 gauge needle will be inserted in the carpal tunnel with the needle tip positioned between retinaculum and median nerve.
Other Name: Triamcinolone injections versus 5% dextrose
Experimental: Corticosteroids or Dextrose vs. Surgery
In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. Surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
 Procedure: Corticosteroid or Dextrose vs. Surgery
Injection will be performed unilaterally, after randomization of sides, by the same examiner as in the first part of the study. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. The procedure will be performed under local anesthesia, following the same standard protocol. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
Other Name: Triamcinolone injections or 5% dextrose versus Carpal tunnel release
Outcome Measures
Primary Outcome Measures :
  1. Visual Analog Scale (VAS) Score [ Time Frame: 1 years ]
    The Visual Analog Scale (VAS) will be used to assess severity of digital paresthesia/dysesthesia and wrist or hand pain on 11-point grading scale. Scores ranges from from 0 to 10 points, with higher scores indicating greater severity of CTS symptoms (0 - no symptoms; 10 - extremely severe symptoms).


Secondary Outcome Measures :
  1. Global Assessment of Treatment Results [ Time Frame: 1 years ]
    At 1-, 3-, 6- and 12-month follow-up assessments, CTS symptoms relief after treatment will be evaluated and categorized as one of the following: (1) much improved, (2) improved, (3) no change, (4) worse, or (5) much worse. Patients in category 1 or 2 will be considered to have effective treatment.

  2. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score [ Time Frame: 1 years ]
    The self-administered Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) (Levine et al., 1993) includes 2 subscales of symptoms severity (11 questions) and functional status (8 questions). It is the most commonly used measurement for CTS. Scores ranges from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.

  3. Median Nerve Distal Motor Latency (DML) [ Time Frame: 1 years ]
    Distal motor latency (DML) will be measured with median nerve stimulation 8 cm proximal to the active electrode over the abductor pollicis brevis muscle in each hand before and at 1-, 3, 6 and 12 months after treatment.

  4. Ulnar and Median Antidromic Sensory Nerve Action Potentials (SNAPs) [ Time Frame: 1 years ]
    Ulnar and median antidromic sensory nerve action potentials (SNAPs) from 4th finger will be recorded on the nerve stimulation 14 cm proximal to recording electrode placed at the middle of the first phalange and SNAP latency difference calculated.

  5. Median Nerve Cross-sectional Area (CSA) [ Time Frame: 1 years ]
    Cross-sectional Area (CSA) of the median nerve will be measured at the wrist and 15 cm proximal at the forearm using a trace method with exclusion of the hyperechoic rim.

  6. Palmar Bowing of the Flexor Retinaculum [ Time Frame: 1 years ]
    Palmar bowing of the flexor retinaculum is a measure used to quantify the internal pressure exerted on the retinaculum from the contents within the carpal tunnel as the perpendicular distance between flexor retinaculum and tangential line between the tip of the pisiform and scaphoid bone.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (subject diagnosed as CTS if meeting criterion 1 + at least one of criteria 2 or 3):

  1. numbness and tingling in at least two out of the first four digits;
  2. symptoms exacerbated during the night or in the morning, on holding the objects or repetitive use of the hand;
  3. symptoms relieved by shaking the hand or reposition of the arm.

In addition to these clinical criteria for recruitment EDx confirmation will also be needed. Only patients with bilateral EDx mild to moderate CTS will be included.

Exclusion Criteria:

  1. polyneuropathy, symptoms of polyneuropathy, and all conditions causing polyneuropathy (e.g., diabetes);
  2. multiple mononeuropathy (e.g., hereditary neuropathy with liability to pressure palsies, syndrome Lewis Sumner);
  3. motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS);
  4. brachial plexopathy;
  5. other focal neuropathies affecting upper limbs (e.g., other median neuropathies, ulnar neuropathies, thoracic outlet syndrome); or
  6. previous surgery or local injections for CTS.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Gregor Omejec, PT, DSc +386 1 522 1502 gregor.omejec@kclj.si
Contact: Simon Podnar, MD +386 1 522 3076 simon.podnar@kclj.si

Locations
Layout table for location information
Slovenia
University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology Recruiting
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019) 		Visual Analog Scale (VAS) Score [ Time Frame: 1 years ]
The Visual Analog Scale (VAS) will be used to assess severity of digital paresthesia/dysesthesia and wrist or hand pain on 11-point grading scale. Scores ranges from from 0 to 10 points, with higher scores indicating greater severity of CTS symptoms (0 - no symptoms; 10 - extremely severe symptoms).
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Improvement/remission [ Time Frame: 2 years ]
Primary outcome of the study will be treatment effectiveness comparison between both hands. Patient will report severity of CTS symptoms for both hands before and at 3, 6 and 12 months after treatment on Analog Visual Scale (0 - no symptoms; 10 - severe symptoms).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • Global Assessment of Treatment Results [ Time Frame: 1 years ]
    At 1-, 3-, 6- and 12-month follow-up assessments, CTS symptoms relief after treatment will be evaluated and categorized as one of the following: (1) much improved, (2) improved, (3) no change, (4) worse, or (5) much worse. Patients in category 1 or 2 will be considered to have effective treatment.
  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score [ Time Frame: 1 years ]
    The self-administered Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) (Levine et al., 1993) includes 2 subscales of symptoms severity (11 questions) and functional status (8 questions). It is the most commonly used measurement for CTS. Scores ranges from 0 to 5 points for each question, with higher scores indicating greater severity and dysfunction.
  • Median Nerve Distal Motor Latency (DML) [ Time Frame: 1 years ]
    Distal motor latency (DML) will be measured with median nerve stimulation 8 cm proximal to the active electrode over the abductor pollicis brevis muscle in each hand before and at 1-, 3, 6 and 12 months after treatment.
  • Ulnar and Median Antidromic Sensory Nerve Action Potentials (SNAPs) [ Time Frame: 1 years ]
    Ulnar and median antidromic sensory nerve action potentials (SNAPs) from 4th finger will be recorded on the nerve stimulation 14 cm proximal to recording electrode placed at the middle of the first phalange and SNAP latency difference calculated.
  • Median Nerve Cross-sectional Area (CSA) [ Time Frame: 1 years ]
    Cross-sectional Area (CSA) of the median nerve will be measured at the wrist and 15 cm proximal at the forearm using a trace method with exclusion of the hyperechoic rim.
  • Palmar Bowing of the Flexor Retinaculum [ Time Frame: 1 years ]
    Palmar bowing of the flexor retinaculum is a measure used to quantify the internal pressure exerted on the retinaculum from the contents within the carpal tunnel as the perpendicular distance between flexor retinaculum and tangential line between the tip of the pisiform and scaphoid bone.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • CTS symptoms [ Time Frame: 2 years ]
    Percentage of hands with complete resolution of symptoms, or pronounced symptom improvement (VAS 8-10)
  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score [ Time Frame: 2 years ]
    Improvement in BCTQ Score for each hand
  • Median_DML [ Time Frame: 2 years ]
    Improvement in median nerve distal motor latency (DML) for each hand
  • SNAP_lat_diff [ Time Frame: 2 years ]
    Improvement in SNAP latency difference between median and ulnar nerve for each hand
  • Median_CSA [ Time Frame: 2 years ]
    Improvement in median nerve CSA at the wrist for each hand
  • CSA_ratio [ Time Frame: 2 years ]
    Improvement in CSA ratio (wrist/forearm) for each hand
  • Bowing [ Time Frame: 2 years ]
    Improvement in flexor retinaculum bowing for each hand
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome
Official Title  ICMJE Efficacy of Dextrose Injections, Corticosteroids Injections and Surgical Release for Treatment of the Carpal Tunnel Syndrome: a Prospective, Randomized, Double-blind Controlled Trial
Brief Summary The objective of the present study is to compare the effectiveness of 5% dextrose, local corticosteroids injections and surgical release in patients with electrodiagnostically (EDx) mild to moderate carpal tunnel syndrome (CTS). The investigators hypothesize that in patients with mild to moderate CTS (1) local 5% dextrose injections is non-inferior to local corticosteroid injections at 12 months after treatment, and that (2) local 5% dextrose injections are of non-inferior effectiveness compared to surgical release at 6 months.
Detailed Description Surgical release of the carpal ligament is a standard treatment of the median nerve entrapment at the wrist. Local corticosteroid injections are also an established alternative, particularly for EDx mild or moderate CTS, although majority of patients still needs surgical decompression within 1 year. Majority of studies concluded that after more than 6 months of treatment surgical decompression is better than local corticosteroids injections. Furthermore, corticosteroids also have a number of side effects, including crystal induced synovitis, tendon rupture, axon and myelin degeneration, soft tissue atrophy, skin thinning, steroid flare and hot flushes. Therefore, it would be very useful to have an effective alternative substance for injections, without these problems. Perineural injection of dextrose also seems to be a promising treatment for entrapment neuropathies. To date only two studies investigated the effectiveness of 5% dextrose injections in patients with CTS. Authors concluded that this is an effective treatment, that is for patients with mild or moderate CTS even more beneficial than corticosteroid injections at 6 months follow-up. It was suggested that perineural injection of 5% dextrose decreases neurogenic inflammation. As 5% dextrose has osmolarity similar to normal saline, this formulation seems particularly promising. These expectations were supported in studies including animals and humans reporting no harmful effects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Patients with bilateral CTS symptoms and EDx mild to moderate CTS will be included. In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance. In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
Masking: Double (Participant, Investigator)
Masking Description:
Each of three investigators performing one part of diagnostic evaluation (history and focal neurologic examination, EDx and (3) ultrasonographic (US) studies) will be blinded for findings of other parts of evaluation. Furthermore, patients will be blinded for laterality of the injected substance.
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Nervous System Diseases
  • Nerve Compression Syndromes
  • Carpal Tunnel Syndrome
Intervention  ICMJE
  • Drug: Corticosteroid vs. Dextrose
    US guided injection of corticosteroid in one hand and 5% glucose in the other will be performed in accordance with randomization. In a syringe both substances will be diluted using 0.9% NaCl to a total injection volume of 6 ml. In-plane ulnar approach will be used to visualize the median nerve at the level of the pisiform bone. A standard 23 gauge needle will be inserted in the carpal tunnel with the needle tip positioned between retinaculum and median nerve.
    Other Name: Triamcinolone injections versus 5% dextrose
  • Procedure: Corticosteroid or Dextrose vs. Surgery
    Injection will be performed unilaterally, after randomization of sides, by the same examiner as in the first part of the study. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. The procedure will be performed under local anesthesia, following the same standard protocol. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
    Other Name: Triamcinolone injections or 5% dextrose versus Carpal tunnel release
Study Arms  ICMJE
  • Experimental: Corticosteroids vs. Dextrose
    In the first part of the study examiner will randomize substance for left hand infiltration using a dice (odd number - corticosteroids; even number - 5% glucose). Right hand will be infiltrated with the remaining substance.
    Intervention: Drug: Corticosteroid vs. Dextrose
  • Experimental: Corticosteroids or Dextrose vs. Surgery
    In the second part of the study examiner will randomize treatment procedure for left hand using a dice (odd number - corticosteroids or 5% glucose; even number - surgery). Substance for injection will be determined according to the results of the first part of the study - more effective one, or in case of non-inferiority 5% glucose will be used. Surgical release will be performed by the same plastic surgeon. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
    Intervention: Procedure: Corticosteroid or Dextrose vs. Surgery
Publications *
  • Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;(3):CD001552. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD001552.
  • Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. Review.
  • Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial. Ann Intern Med. 2013 Sep 3;159(5):309-17. doi: 10.7326/0003-4819-159-5-201309030-00004.
  • Andreu JL, Ly-Pen D, Millán I, de Blas G, Sánchez-Olaso A. Local injection versus surgery in carpal tunnel syndrome: neurophysiologic outcomes of a randomized clinical trial. Clin Neurophysiol. 2014 Jul;125(7):1479-84. doi: 10.1016/j.clinph.2013.11.010. Epub 2013 Nov 23.
  • Ly-Pen D, Andréu JL, de Blas G, Sánchez-Olaso A, Millán I. Surgical decompression versus local steroid injection in carpal tunnel syndrome: a one-year, prospective, randomized, open, controlled clinical trial. Arthritis Rheum. 2005 Feb;52(2):612-9.
  • Ly-Pen D, Andréu JL, Millán I, de Blas G, Sánchez-Olaso A. Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial. Rheumatology (Oxford). 2012 Aug;51(8):1447-54. doi: 10.1093/rheumatology/kes053. Epub 2012 Mar 30.
  • Celik G, Ilik MK. Effects of Two Different Treatment Techniques on the Recovery Parameters of Moderate Carpal Tunnel Syndrome: A Six-Month Follow-up Study. J Clin Neurophysiol. 2016 Apr;33(2):166-70. doi: 10.1097/WNP.0000000000000243.
  • Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B. Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice. BMC Fam Pract. 2010 Jul 29;11:54. doi: 10.1186/1471-2296-11-54.
  • Ustün N, Tok F, Yagz AE, Kizil N, Korkmaz I, Karazincir S, Okuyucu E, Turhanoglu AD. Ultrasound-guided vs. blind steroid injections in carpal tunnel syndrome: A single-blind randomized prospective study. Am J Phys Med Rehabil. 2013 Nov;92(11):999-1004. doi: 10.1097/PHM.0b013e31829b4d72.
  • Lee JY, Park Y, Park KD, Lee JK, Lim OK. Effectiveness of ultrasound-guided carpal tunnel injection using in-plane ulnar approach: a prospective, randomized, single-blinded study. Medicine (Baltimore). 2014 Dec;93(29):e350. doi: 10.1097/MD.0000000000000350.
  • Makhlouf T, Emil NS, Sibbitt WL Jr, Fields RA, Bankhurst AD. Outcomes and cost-effectiveness of carpal tunnel injections using sonographic needle guidance. Clin Rheumatol. 2014 Jun;33(6):849-58. doi: 10.1007/s10067-013-2438-5. Epub 2013 Nov 26.
  • Wang JC, Liao KK, Lin KP, Chou CL, Yang TF, Huang YF, Wang KA, Chiu JW. Efficacy of Combined Ultrasound-Guided Steroid Injection and Splinting in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):947-956. doi: 10.1016/j.apmr.2017.01.018. Epub 2017 Feb 14.
  • Wang PH, Tsai CL, Lee JS, Wu KC, Cheng KI, Jou IM. Effects of topical corticosteroids on the sciatic nerve: an experimental study to adduce the safety in treating carpal tunnel syndrome. J Hand Surg Eur Vol. 2011 Mar;36(3):236-43. doi: 10.1177/1753193410390760. Epub 2011 Jan 31.
  • Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
  • Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
  • Hashimoto K, Sakura S, Bollen AW, Ciriales R, Drasner K. Comparative toxicity of glucose and lidocaine administered intrathecally in the rat. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):444-50.
  • Sakura S, Chan VW, Ciriales R, Drasner K. The addition of 7.5% glucose does not alter the neurotoxicity of 5% lidocaine administered intrathecally in the rat. Anesthesiology. 1995 Jan;82(1):236-40.
  • Tsui BC, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-9.
  • Dufour E, Donat N, Jaziri S, Kurdi O, Couturier C, Dreyfus JF, Fischler M. Ultrasound-guided perineural circumferential median nerve block with and without prior dextrose 5% hydrodissection: a prospective randomized double-blinded noninferiority trial. Anesth Analg. 2012 Sep;115(3):728-33. doi: 10.1213/ANE.0b013e31825fa37d. Epub 2012 Jun 28.
  • Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92.
  • Ng AWH, Griffith JF, Lee RKL, Tse WL, Wong CWY, Ho PC. Ultrasound carpal tunnel syndrome: additional criteria for diagnosis. Clin Radiol. 2018 Feb;73(2):214.e11-214.e18. doi: 10.1016/j.crad.2017.07.025. Epub 2017 Aug 30.
  • Lee YS, Choi E. Ultrasonographic changes after steroid injection in carpal tunnel syndrome. Skeletal Radiol. 2017 Nov;46(11):1521-1530. doi: 10.1007/s00256-017-2738-y. Epub 2017 Aug 2.
  • Gonzalez-Suarez CB, Fidel BC, Cabrera JTC, Dela Cruz FC, Gesmundo MVT, Regala CFG, Saratan R, Suarez CG, Grimmer K. Diagnostic Accuracy of Ultrasound Parameters in Carpal Tunnel Syndrome: Additional Criteria for Diagnosis. J Ultrasound Med. 2019 Nov;38(11):3043-3052. doi: 10.1002/jum.15012. Epub 2019 Apr 17.
  • Smith J, Wisniewski SJ, Finnoff JT, Payne JM. Sonographically guided carpal tunnel injections: the ulnar approach. J Ultrasound Med. 2008 Oct;27(10):1485-90. Review.
  • Scholten RJ, Mink van der Molen A, Uitdehaag BM, Bouter LM, de Vet HC. Surgical treatment options for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003905. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2023
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (subject diagnosed as CTS if meeting criterion 1 + at least one of criteria 2 or 3):

  1. numbness and tingling in at least two out of the first four digits;
  2. symptoms exacerbated during the night or in the morning, on holding the objects or repetitive use of the hand;
  3. symptoms relieved by shaking the hand or reposition of the arm.

In addition to these clinical criteria for recruitment EDx confirmation will also be needed. Only patients with bilateral EDx mild to moderate CTS will be included.

Exclusion Criteria:

  1. polyneuropathy, symptoms of polyneuropathy, and all conditions causing polyneuropathy (e.g., diabetes);
  2. multiple mononeuropathy (e.g., hereditary neuropathy with liability to pressure palsies, syndrome Lewis Sumner);
  3. motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS);
  4. brachial plexopathy;
  5. other focal neuropathies affecting upper limbs (e.g., other median neuropathies, ulnar neuropathies, thoracic outlet syndrome); or
  6. previous surgery or local injections for CTS.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gregor Omejec, PT, DSc +386 1 522 1502 gregor.omejec@kclj.si
Contact: Simon Podnar, MD +386 1 522 3076 simon.podnar@kclj.si
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014244
Other Study ID Numbers  ICMJE Treatment SZP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregor Omejec, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯