Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

NCT ID: NCT04848324

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

14 patients (14 hands) who received US-guided corticosteroid hydrodissection

Group Type ACTIVE_COMPARATOR

Corticosteroid Hydrodissection

Intervention Type OTHER

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.

Control group

14 patients (14 hands) who received US-guided corticosteroid injection

Group Type ACTIVE_COMPARATOR

Corticosteroid Injection

Intervention Type OTHER

1 mL of triamcinolone was delivered via the in-plane ulnar approach

Interventions

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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.

Intervention Type OTHER

Corticosteroid Injection

1 mL of triamcinolone was delivered via the in-plane ulnar approach

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Physical Medicine and Rehabilitation Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merve Orucu Atar

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR

Locations

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Merve Orucu Atar

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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15

Identifier Type: -

Identifier Source: org_study_id

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