Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

NCT04848324 | Completed

• 1 other identifier: 15
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; ultrasonography; hydrodissection; steroid injection

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Short Form 12 (SF-12)

  baseline, change from baseline SF-12 at 1 and 4 weeks after injection

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Other: Corticosteroid Hydrodissection

Control group

ACTIVE COMPARATOR

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

Other: Corticosteroid Injection

Interventions

Corticosteroid Hydrodissection 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.

Intervention group

Corticosteroid Injection OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Merve Orucu Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Merve Orucu Atar

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Associate Professor

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: December 1, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

TU (1)