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Completed

NCT Number: NCT04848324

Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Merve Orucu Atar

Ankara, Cankaya, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Corticosteroid injection

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

  1. Short Form 12 (SF-12)

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

    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.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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