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Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Corticosteroid Hydrodissection
Corticosteroid Injection
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, ultrasonography, hydrodissection, steroid injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Merve Orucu Atar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 9, 2021
Last Updated
April 13, 2021
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04848324
Brief Title
Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection
Official Title
Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, ultrasonography, hydrodissection, steroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
14 patients (14 hands) who received US-guided corticosteroid hydrodissection
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
14 patients (14 hands) who received US-guided corticosteroid injection
Intervention Type
Other
Intervention Name(s)
Corticosteroid Hydrodissection
Intervention Description
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
Intervention Name(s)
Corticosteroid Injection
Intervention Description
1 mL of triamcinolone was delivered via the in-plane ulnar approach
Primary Outcome Measure Information:
Title
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Description
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.
Time Frame
baseline, change from baseline BCTQ at 1 and 4 weeks after injection
Title
Hand grip strength (HGS)
Description
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
Time Frame
baseline, change from baseline HGS at 1 and 4 weeks after injection
Title
Cross-Sectional Area of the Median Nerve
Description
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.
Time Frame
baseline, change from baseline CSA at 1 and 4 weeks after injection
Secondary Outcome Measure Information:
Title
Short Form 12 (SF-12)
Description
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.
Time Frame
baseline, change from baseline SF-12 at 1 and 4 weeks after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Orucu Atar
Organizational Affiliation
Gaziler Physical Medicine and Rehabilitation, Training and Research Hospital, Department of PMR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Merve Orucu Atar
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

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Short-Term Effectiveness of Ultrasound-Guided Corticosteroid Hydrodissection

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