Peripheral Nervous System DiseasesNCT04014244
Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome
A study testing Corticosteroid vs. Dextrose and Corticosteroid or Dextrose vs. Surgery in people with Peripheral Nervous System Diseases and Nerve Compression Syndromes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Nervous System Diseases, Nerve Compression Syndromes, Carpal Tunnel Syndrome
- What is being tested?
- Corticosteroid vs. Dextrose and Corticosteroid or Dextrose vs. Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
Ljubljana, 1000
About this study
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
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.
Read the 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.
- Being tested
- Corticosteroid vs. Dextrose, Corticosteroid or Dextrose vs. Surgery
- Keywords
- Carpal Tunnel Syndrome, Electromyography, Ultrasonography, Surgery, Dextrose, Corticosteroids
- Medical subject headings
- Peripheral Nervous System Diseases, Nerve Compression Syndromes, Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid vs. DextroseDrug
Also called Triamcinolone injections versus 5% 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.
Corticosteroid or Dextrose vs. SurgeryProcedure or surgery
Also called Triamcinolone injections or 5% dextrose versus Carpal tunnel release
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.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids vs. Dextrose | Experimental | 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. Receives: Drug: Corticosteroid vs. Dextrose |
| Corticosteroids or Dextrose vs. Surgery | Experimental | 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. Receives: Procedure: Corticosteroid or Dextrose vs. Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Score
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).
Measured: 1 years
Secondary outcomes (6)
Global Assessment of Treatment Results
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.
Measured: 1 years
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score
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.
Measured: 1 years
Median Nerve Distal Motor Latency (DML)
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.
Measured: 1 years
Ulnar and Median Antidromic Sensory Nerve Action Potentials (SNAPs)
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.
Measured: 1 years
Median Nerve Cross-sectional Area (CSA)
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.
Measured: 1 years
Palmar Bowing of the Flexor Retinaculum
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.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Mar 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Omejec, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014244
- Sponsor's protocol ID
- Treatment SZP
- Status last verified
- Mar 2021
- First submitted
- 8 Jul 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1002/14651858.CD001552.
PubMed 12917909Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.
PubMed 17443508Atroshi 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.
PubMed 24026316Andreu 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.
PubMed 24321619Ly-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.
PubMed 15692981Ly-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.
PubMed 22467087Celik 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.
PubMed 26657237Peters-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.
PubMed 20670438Ustun 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.
PubMed 23811617Lee 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.
PubMed 25546691Makhlouf 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.
PubMed 24277115Wang 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.
PubMed 28209506Wang 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.
PubMed 21282223Wu 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.
PubMed 28778254Wu 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.
PubMed 30187524
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04014244
- Acronym / sponsor ID
- Treatment SZP
- Keywords
- Carpal Tunnel Syndrome, Electromyography, Ultrasonography, Surgery, Dextrose, Corticosteroids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids vs. Dextrose | Experimental | Drug: Corticosteroid vs. DextroseIn 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. |
| Corticosteroids or Dextrose vs. Surgery | Experimental | Procedure: Corticosteroid or Dextrose vs. SurgeryIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid vs. DextroseAlso: Triamcinolone injections versus 5% dextroseUS 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. | Drug | Corticosteroids vs. Dextrose |
| Corticosteroid or Dextrose vs. SurgeryAlso: Triamcinolone injections or 5% dextrose versus Carpal tunnel releaseInjection 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. | Procedure or surgery | Corticosteroids or Dextrose vs. Surgery |
Primary outcome
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).
6 secondary outcomes
Global Assessment of Treatment Results
Time frame: 1 years
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) Score
Time frame: 1 years
Median Nerve Distal Motor Latency (DML)
Time frame: 1 years
Ulnar and Median Antidromic Sensory Nerve Action Potentials (SNAPs)
Time frame: 1 years
Median Nerve Cross-sectional Area (CSA)
Time frame: 1 years
Palmar Bowing of the Flexor Retinaculum
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 12917909Verdugo 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.
- Background: PubMed 17443508Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.
- Background: PubMed 24026316Atroshi 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.
- Background: PubMed 24321619Andreu 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.
- Background: PubMed 15692981Ly-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.
- Background: PubMed 22467087Ly-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.
- Background: PubMed 26657237Celik 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.
- Background: PubMed 20670438Peters-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.
- Background: PubMed 23811617Ustun 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.
- Background: PubMed 25546691Lee 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.
- Background: PubMed 24277115Makhlouf 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.
- Background: PubMed 28209506Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corticosteroid vs. Dextrose and Corticosteroid or Dextrose vs. Surgery in people with Peripheral Nervous System Diseases and Nerve Compression Syndromes, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregor Omejec, PT, DSc (+386 1 522 1502, gregor.omejec@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Score (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014244, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.