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Trial record 56 of 337 for:    Charcot Marie Tooth

Dextrose, Corticosteroids and Surgical Release in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT04014244
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Gregor Omejec, University Medical Centre Ljubljana

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.

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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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014244


Contacts
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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
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Slovenia
University Medical Center Ljubljana, Department of Neurology, Institute of Clinical Neurophysiology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

Publications:

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Responsible Party: Gregor Omejec, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04014244     History of Changes
Other Study ID Numbers: Treatment SZP
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregor Omejec, University Medical Centre Ljubljana:
Carpal Tunnel Syndrome
Electromyography
Ultrasonography
Surgery
Dextrose
Corticosteroids
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Charcot-Marie-Tooth Disease
Hereditary Sensory and Motor Neuropathy
Carpal Tunnel Syndrome
Peripheral Nervous System Diseases
Syndrome
Nervous System Diseases
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Neuromuscular Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Congenital Abnormalities
Genetic Diseases, Inborn
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs