Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

Carpal Tunnel Syndrome Clinical Trial

Official title:

Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection in Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848324
• Other study ID #: 15
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: April 2021
• Source: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term. The aim of this study was to determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Description:

Background: Steroid injections are remarkably effective as a treatment for carpal tunnel syndrome (CTS) in the short term.

Aim: To determine whether hydrodissection would provide an additional clinical effect when used along with a corticosteroid in the short term.

Methods: A prospective cohort of patients with CTS were retrospectively evaluated. 28 patients were selected randomly who received ultrasound (US)-guided triamcinolone hydrodissection (3 mL) as intervention group and received US-guided triamcinolone injection (1 mL) as control group, from the data (case-control ratio 1:1). Outcome measures were the Boston Carpal Tunnel Questionnaire (BCTQ), hand grip strength (HGS), fhe cross-sectional area (CSA) of the median nerve and Short Form 12 (SF-12). Assessments were recorded at baseline, 1 and 4 weeks after injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. aged between 18-65

2. clinically diagnosed with CTS

3. electrophysiologically confirmed mild-to-moderate CTS

4. having typical CTS symptoms for at least 3 months

5. not benefiting from splinting and resting.

Exclusion Criteria:

1. electrophysiologically diagnosed with severe CTS

2. surgery history for CTS

3. presence of metabolic, endocrine and neoplastic disorders

4. presence of other neurological disorders (such as plexopathy, cervical radiculopathy, proximal median or ulnar neuropathy, polyneuropathy and mononeuritis multiplex)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Corticosteroid Hydrodissection
The median nerve was examined by US at the scaphoid-pisiform level of the inlet of carpal tunnel. The hydrodissection was achieved by a total volume of 3 mL (1 mL of triamcinolone and 2 mL of saline) in the intervention group based on a study identifying median nerve hydrodissection with this volume. Half of the total volume (1.5 mL ) was delivered via the in-plane ulnar approach and the other half (1.5 mL) via the in-plane median approach to create a fluid plane along the nerve.
• Corticosteroid Injection
1 mL of triamcinolone was delivered via the in-plane ulnar approach

Locations

Country	Name	City	State
Turkey	Merve Orucu Atar	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	The Boston Carpal Tunnel Questionnaire (BCTQ) consisting of two subscales (Symptom Severity Scale (SSS) and Functional Status Scale (FSS)) was filled out by the patient him/herself. Both subscales of BCTQ are scored between 1 and 5, and higher scores illustrate a greater degree of disability. The Turkish validity of the questionnaire was demonstrated.	baseline, change from baseline BCTQ at 1 and 4 weeks after injection
Primary	Hand grip strength (HGS)	The Standard Jamar Dynamometer was used to measure HGS. The patients were placed in a sitting position with the forearm in a neutral position and the elbow in 90 ° flexion. Three consecutive measurements were performed and the average value of the measurements were noted. Studies have shown that the Jamar dynamometer has high validity and reliability and is considered to be the gold standard for evaluating HGS	baseline, change from baseline HGS at 1 and 4 weeks after injection
Primary	Cross-Sectional Area of the Median Nerve	The cross-sectional area (CSA) of the median nerve was measured at the scaphoid-pisiform level by using US since the swelling of the median nerve is a reliable measure for post-injection follow-up at this level (Figure 3). Three measurements were done and averaged for analysis.	baseline, change from baseline CSA at 1 and 4 weeks after injection
Secondary	Short Form 12 (SF-12)	Quality of life was assessed with the Turkish version of Short Form 12 (SF-12). A physical component score and a mental component score are obtained from the SF-12. Higher scores show better outcomes.	baseline, change from baseline SF-12 at 1 and 4 weeks after injection