Hydrodissection Between Normal Saline and a Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in CTS

January 10, 2024 updated by: Md Mamunul Abedin, Bangladesh College Of Physicians And Surgeons (BCPS)

Outcome Comparison of Ultrasound-guided Hydrodissection Between Normal Saline and Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in Mild to Moderate Carpal Tunnel Syndrome: A Single Blinded Randomized Clinical Trial

The goal of this randomized clinical trial is to compare the functional outcome of hydrodissection of the median nerve by normal saline only and a combination of triamcinolone acetonide, lidocaine, and normal saline.

The main question it aims to answer are:

• What is the outcome comparison of ultrasound-guided hydrodissection between normal saline only and combination of triamcinolone acetonide, normal saline, and lidocaine in mild to moderate carpal tunnel syndrome?

Participants diagnosed with mild or moderate CTS will be randomly assigned to two groups and be hydrodissected under ultrasound guidance.

Researchers will compare if normal saline gives similar or better functional outcomes than steroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carpal Tunnel Syndrome (CTS) is the most prevalent entrapment neuropathy caused by median nerve compression in carpal tunnel characterized by nocturnal paresthesia, tingling, numbness and pain involving glove or median distribution in hand. Almost all patients are from working group of different occupations.

The non-surgical treatments are for patients having mild to moderate CTS and these include oral steroids, drugs, braces, ultrasound therapy, tendon-gliding exercises, local steroid injection or hydrodissection etc. Hydrodissection for CTS includes injecting fluid around the nerve to eliminate the adhesions, restore blood supply and improve kinematic properties of the entrapped nerve. Ultrasound (US) - guided in-plane ulnar approach for hydrodissection in the CTS is more effective & safer. Traditionally, the steroid (triamcinolone acetonide) combined with normal saline & lidocaine is injected for this procedure. Though, the steroid injection shows greater clinical improvement only for short term, there are also possible side effects like short-lived local pain (13%), widespread axonal & myelin degeneration, skin thinning & depigmentation etc. Whereas, Normal saline (NS) is an isotonic fluid which would be suitable for expanding the perineural space. There are only a few studies comparing the outcome of hydrodissection with normal saline and triamcinolone acetonide in carpal tunnel syndrome, although the steroid injection is well established in management of CTS. Therefore, this study aims to compare the outcome between normal saline alone with combination of triamcinolone, normal saline & lidocaine. This will be a randomized clinical trial conducting in the department of Physical Medicine and Rehabilitation, Shaheed Suhrawardy Medical College Hospital, Bangladesh for 12-months period following approval of this protocol. Ethical clearance will be obtained from Ethical Review Committee (ERC) of above-mentioned hospital.

A total of 62 (sixty-two) patients above 18 years with clinical features of CTS lasting for more than 04 (four) weeks will be selected by convenience sampling and enrolled by following exclusion-inclusion criteria. All cases will be randomly assigned in to two groups (31 cases in each group) and get following treatment, i.e. Group A: Hydrodissection by 05 ml of normal saline only; Group B: Hydrodissection by 05 ml of combination of triamcinolone acetonide, normal saline & lidocaine; Both groups: Gabapentin, Neurotropic B vitamins, static wrist splint overnight, tendon gliding exercises, maintaining Activities of Daily Living (ADL) advices. Outcome will be measured by Symptom severity scale (SSS) & Functional status scale (FSS) of Boston Carpal Tunnel Questionnaire (BCQT), and Numeric pain rating score (NRS-11). Data will be taken before intervention (baseline) and 4th, 8th & 12th week after intervention. The cross-sectional area of the median nerve at carpal tunnel inlet will also be measured at the baseline & at the 12th week follow-up.

Data will be collected in a predesigned data collection sheet by face-to-face. The statistical analysis will be conducted using Statistical Package for the Social Sciences (SPSS) version 25 statistical software. The Mann-Whitney U-test and chi-square test/Fisher exact test will be used for continuous and categorical data, respectively. Intragroup data at different follow-up time-points will be evaluated using the Wilcoxon signed rank test. Differences between groups will be measured using the Mann-Whitney U-test. All statistical tests will be two-tailed, with P<0.05 considered significant. Bonferroni correction will be performed for intergroup comparisons at different time-points. All data will be presented as mean, frequency and percentages in tables, line charts etc.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1207
        • Shaheed Suhrawardy Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients having pain and/or numbness, paresthesia in median nerve or glove distribution area with night symptoms for more than 4 weeks
  • Patients age from 18 years of both sexes
  • Electrodiagnostically (by NCS) confirmed and categorized as mild or moderate carpal tunnel syndrome
  • Willing to participate

Exclusion Criteria:

  • Patients having other diseases, like: Cervical radiculopathy, Other neuropathy
  • History of taking systemic corticosteroids within 04-weeks prior study
  • Pregnancy
  • History of distal forearm or wrist fracture, trauma or deformity
  • Previous CTS surgery or steroid injection in carpal tunnel
  • Thenar atrophy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrodissection with Normal Saline
This group will be hydrodissected by 5 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices.
Drug: Ultrasound-guided Hydrodissection of the Median Nerve
Hydrodissection for CTS includes injecting fluid around the median nerve (MN) with 5 ml volume, 3 ml of which is given in between the transverse carpal ligament & MN, and 2 ml below the MN under Ultrasound guidance in-plane ulnar approach.
Other Names:
  • Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline
  • Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone Acetonide
Active Comparator: Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline
This group will be hydrodissected by 5 ml combination of 1 ml of triamcinolone, 1 ml of lidocaine & 3 ml of normal saline, will take Gabapentin 300 mg twice daily, Neurotropic B vitamin twice daily, wear a static wrist splint in neutral position overnight, perform tendon gliding exercises 10 repetitions three times daily and maintain ADL advices.
Drug: Ultrasound-guided Hydrodissection of the Median Nerve
Hydrodissection for CTS includes injecting fluid around the median nerve (MN) with 5 ml volume, 3 ml of which is given in between the transverse carpal ligament & MN, and 2 ml below the MN under Ultrasound guidance in-plane ulnar approach.
Other Names:
  • Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline
  • Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone Acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carpal Tunnel Syndrome disease severity
Time Frame: 3 months
It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-Sectional Area (CSA) of the Median Nerve
Time Frame: 3 months
It will be measured by ultrasound
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh College Of Physicians And Surgeons (BCPS)

Investigators

  • Principal Investigator: Dr Mamunul Abedin, Bangladesh College of Physicians and Surgeons

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carpal Tunnel Syndrome

Clinical Trials on Ultrasound-guided Hydrodissection of the Median Nerve

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe