- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014244
Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome
March 8, 2021 updated by: Gregor Omejec, University Medical Centre Ljubljana
Efficacy of Dextrose Injections, Corticosteroids Injections and Surgical Release for Treatment of the Carpal Tunnel Syndrome: a Prospective, Randomized, Double-blind Controlled Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simon Podnar, MD
- Phone Number: +386 1 522 3076
- Email: simon.podnar@kclj.si
Study Locations
-
-
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Ljubljana, Slovenia, 1000
- Recruiting
- University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (subject diagnosed as CTS if meeting criterion 1 + at least one of criteria 2 or 3):
- numbness and tingling in at least two out of the first four digits;
- symptoms exacerbated during the night or in the morning, on holding the objects or repetitive use of the hand;
- 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:
- polyneuropathy, symptoms of polyneuropathy, and all conditions causing polyneuropathy (e.g., diabetes);
- multiple mononeuropathy (e.g., hereditary neuropathy with liability to pressure palsies, syndrome Lewis Sumner);
- motor neuron disorders (e.g., monomelic amyotrophy, amyotrophic lateral sclerosis - ALS);
- brachial plexopathy;
- other focal neuropathies affecting upper limbs (e.g., other median neuropathies, ulnar neuropathies, thoracic outlet syndrome); or
- previous surgery or local injections for CTS.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 years
|
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.
|
1 years
|
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.
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1 years
|
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.
|
1 years
|
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.
|
1 years
|
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.
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;(3):CD001552. doi: 10.1002/14651858.CD001552.
- Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.
- 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, Millan I, de Blas G, Sanchez-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, Andreu JL, de Blas G, Sanchez-Olaso A, Millan 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. doi: 10.1002/art.20767.
- Ly-Pen D, Andreu JL, Millan I, de Blas G, Sanchez-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.
- Ustun 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, 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. doi: 10.1016/s1098-7339(98)90025-6.
- 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. doi: 10.1097/00000542-199501000-00028.
- Tsui BCH, Kropelin B. The electrophysiological effect of dextrose 5% in water on single-shot peripheral nerve stimulation. Anesth Analg. 2005 Jun;100(6):1837-1839. doi: 10.1213/01.ANE.0000153020.84780.A5.
- 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. doi: 10.2106/00004623-199311000-00002.
- 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. doi: 10.7863/jum.2008.27.10.1485.
- 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;2007(4):CD003905. doi: 10.1002/14651858.CD003905.pub3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2021
Primary Completion (ANTICIPATED)
March 1, 2022
Study Completion (ANTICIPATED)
September 1, 2023
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (ACTUAL)
July 10, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 11, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Wounds and Injuries
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Mononeuropathies
- Median Neuropathy
- Cumulative Trauma Disorders
- Sprains and Strains
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Syndrome
- Carpal Tunnel Syndrome
- Peripheral Nervous System Diseases
- Nervous System Diseases
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- Treatment SZP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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