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Clinical Trials/NCT04848324
NCT04848324CompletedNot Applicable

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

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital2 sites in 1 country28 target enrollmentStarted: December 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
2
Primary Endpoint
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • aged between 18-65
  • clinically diagnosed with CTS
  • electrophysiologically confirmed mild-to-moderate CTS
  • having typical CTS symptoms for at least 3 months
  • not benefiting from splinting and resting.

Exclusion Criteria

  • electrophysiologically diagnosed with severe CTS
  • surgery history for CTS
  • presence of metabolic, endocrine and neoplastic disorders
  • presence of other neurological disorders (such as plexopathy, cervical radiculopathy, proximal median or ulnar neuropathy, polyneuropathy and mononeuritis multiplex)

Outcomes

Primary Outcomes

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

Time Frame: baseline, change from baseline BCTQ at 1 and 4 weeks after injection

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.

Hand grip strength (HGS)

Time Frame: baseline, change from baseline HGS at 1 and 4 weeks after injection

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

Cross-Sectional Area of the Median Nerve

Time Frame: baseline, change from baseline CSA at 1 and 4 weeks after injection

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.

Secondary Outcomes

  • Short Form 12 (SF-12)(baseline, change from baseline SF-12 at 1 and 4 weeks after injection)

Investigators

Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasin Demir

Physical Medicine and Rehabilitation Associate Professor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Sites (2)

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