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

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Ultrasound-guided Hydrodissection of the Median Nerve
Sponsored by
Bangladesh College Of Physicians And Surgeons (BCPS)
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, CTS, Hydrodissection, Normal Saline, Triamcinolone, Ultrasound Guided

Eligibility Criteria

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

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

Sites / Locations

  • Shaheed Suhrawardy Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrodissection with Normal Saline

Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Carpal Tunnel Syndrome disease severity
It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)

Secondary Outcome Measures

Cross-Sectional Area (CSA) of the Median Nerve
It will be measured by ultrasound

Full Information

First Posted
October 10, 2022
Last Updated
October 11, 2022
Sponsor
Bangladesh College Of Physicians And Surgeons (BCPS)
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1. Study Identification

Unique Protocol Identification Number
NCT05577676
Brief Title
Hydrodissection Between Normal Saline and a Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in CTS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
September 12, 2023 (Anticipated)
Study Completion Date
September 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangladesh College Of Physicians And Surgeons (BCPS)

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

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, CTS, Hydrodissection, Normal Saline, Triamcinolone, Ultrasound Guided

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients of CTS for at least 04 weeks will be selected. Informed written consent will be taken. Data will be collected by face-to-face interview. Total 62 samples will then be randomly allocated into two groups. One group will receive 5 ml of normal saline and another group will receive 5 ml combination of triamcinolone, lidocaine & normal saline. Both group will also receive Gabapentin, B vitamin, static wrist splint overnight, tendon gliding exercises and ADL advices. After taking all aseptic measures, a 23-gauze needle will be placed between transverse carpal ligament & median nerve where 3 ml fluid is given and then, at below the median nerve where another 2 ml fluid is injected. The patients will be kept in a sitting position and observed for 10 to 15 minutes before discharge.
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrodissection with Normal Saline
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydrodissection with Combination of Triamcinolone, Lidocaine, Normal Saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ultrasound-guided Hydrodissection of the Median Nerve
Other Intervention Name(s)
Ultrasound-guided Hydrodissection of the Median Nerve with Normal Saline, Ultrasound-guided Hydrodissection of the Median Nerve with Triamcinolone Acetonide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Carpal Tunnel Syndrome disease severity
Description
It will be measured by Boston Carpal Tunnel Questionnaire and Numeric Pain Rating scale (NRS-11)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cross-Sectional Area (CSA) of the Median Nerve
Description
It will be measured by ultrasound
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Md Mamunul Abedin, MBBS
Phone
+8801717442504
Email
dr_shimul@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Mamunul Abedin
Organizational Affiliation
Bangladesh College of Physicians and Surgeons
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Suhrawardy Medical College Hospital
City
Dhaka
ZIP/Postal Code
1207
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Md Mamunul Abedin, MBBS
Phone
+8801717442504
Email
dr_shimul@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Hydrodissection Between Normal Saline and a Combination of Triamcinolone Acetonide, Normal Saline, and Lidocaine in CTS

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