Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone in Carpal Tunnel Syndrome
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ClinicalTrials.gov Identifier: NCT06045013 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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The goal of this prospective, randomized, double-blinded, head-to-head comparative study is to compare the efficacy of ultrasound-guided 4 ml 5% dextrose perineural injection versus 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone perineural injection in patients with carpal tunnel syndrome (CTS).
The main questions it aims to answer are:
Is there a difference in efficacy between interventions regarding 1. pain alleviation, 2. improvement in symptoms severity and functional status, 3. improvement in grip strength, 4. size of median nerve cross-sectional area, and 5. improvement in quality of life during the six-month post-intervention follow-up period?
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carpal Tunnel Syndrome | Drug: 5% dextrose injection Drug: 5% dextrose injections with methylprednisolone acetate 40 mg/ml | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Comparison of the Efficacy Between Ultrasound-guided Dextrose Injection Versus Dextrose With Methylprednisolone Injection in Patients With Carpal Tunnel Syndrome: a Prospective, Randomized Double-blind Clinical Trial. |
Actual Study Start Date : | September 13, 2023 |
Estimated Primary Completion Date : | January 1, 2026 |
Estimated Study Completion Date : | August 30, 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 5% dextrose injection
Ultrasound-guided 4 ml single injection of 5% dextrose
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Drug: 5% dextrose injection
Single ultrasound-guided injection of 4 ml 5% dextrose in carpal tunnel via ulnar approach.
Other Name: 5% dextrose |
Active Comparator: 5% dextrose injections with methylprednisolone acetate
Ultrasound-guided single injection of 3 ml 5% dextrose plus 1 ml 40 mg/ml methylprednisolone acetate
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Drug: 5% dextrose injections with methylprednisolone acetate 40 mg/ml
Single ultrasound-guided injection of 3 ml 5% dextrose with 1 ml 40 mg/ml methylprednisolone acetate in carpal tunnel via ulnar approach.
Other Name: Depo-Medrol 40 mg/ml |
- Pain intensity at 4 weeks post injection [ Time Frame: before injection, 4 weeks post injection ]Assessment of pain intensity using 10 cm Visual Analogue Scale (VAS pain), 0-10; 0=no pain, 10=the most severe pain.
- Pain intensity at 12 and 24 weeks post injection [ Time Frame: before injection,12 and 24 weeks post injection. ]Assessment of pain intensity using 10 cm Visual Analogue Scale (VAS pain), 0-10; 0=no pain, 10=the most severe pain.
- Symptoms severity and functional impairment of carpal tunnel syndrome (CTS) [ Time Frame: before injection, 4, 12 and 24 weeks post injection. ]Assessment of CTS symptoms severity and functional impairment using the Boston Carpal Tunnel Questionnaire (BCTQ).
- Grip strength [ Time Frame: before injection, 4, 12 and 24 weeks post injection. ]Assessment of grip strength using the Jamar hydraulic hand dynamometer in kilograms.
- Median nerve cross-sectional area (CSA) [ Time Frame: before injection, 4, 12 and 24 weeks post injection. ]The CSA of the median nerve measured by diagnostic ultrasound at the level of carpal tunnel.
- Quality of life (QoL) [ Time Frame: before injection, 4, 12 and 24 weeks post injection. ]Assessment of QoL using 36-Item Short Form Survey (SF-36).
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 18 and 80 years,
- the diagnosis of idiopathic CTS.
Exclusion Criteria:
- contraindications for local application of methylprednisolone or 5% dextrose (hypersensitivity to the drug, infection and skin damage at the application site),
- previous wrist surgery,
- traumatic wrist injury within 2 years,
- previous wrist injection within 6 months,
- previous physical therapy within 6 months,
- history of peripheral traumatic nerve injury in the upper extremity, brachial plexopathy, severe cervical radiculopathy, and thoracic outlet syndrome,
- history of diabetes
- history of thyroid disease,
- history of inflammatory rheumatic disease,
- pregnancy,
- inability to cooperate with the study protocol.
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): NCT06045013
Contact: Igor Begović, MD | +385911748137 | igorbegovic2@gmail.com | |
Contact: Nadica Laktašić Žerjavić, Prof,MD,PhD. | +385915606957 | nadica_laktasic@yahoo.com |
Croatia | |
General and Veteran Hospital "Croatian Pride" Knin | Recruiting |
Knin, Croatia, 22300 | |
Contact: Igor Begović, MD +385911748137 igorbegovic2@gmail.com | |
Contact: Marija Anić Matić, Med.techn. +385915257241 glavnasestra@obhpknin.hr | |
Sub-Investigator: Nadica Laktašić Žerjavić, Prof,MD,PhD. | |
Sub-Investigator: Milan MIlošević, Prof,MD,PhD. | |
Sub-Investigator: Željka Pandža, MD | |
Sub-Investigator: Marija Anić Matić, Med.techn. |
Principal Investigator: | Igor Begović, MD | General and Veteran Hospital "Croatian Pride" Knin, Croatia |
Publications:
Responsible Party: | Igor Begović, Physical medicine and rehabilitation specialist, General and Veteran Hospital Croatian Pride Knin |
ClinicalTrials.gov Identifier: | NCT06045013 |
Other Study ID Numbers: |
510.01/23-01/76 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Carpal Tunnel Syndrome; Ultrasonography; Injections; Glucose; Glucocorticoids; Pain; Functional Status; Hand Strength, Quality of Life |
Carpal Tunnel Syndrome Syndrome Disease Pathologic Processes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Methylprednisolone Methylprednisolone Acetate |
Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents |