CTRI

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CTRI Number

CTRI/2024/12/077997 [Registered on: 12/12/2024] Trial Registered Prospectively

Last Modified On:

11/12/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Biological
Other (Specify) [5% DEXTROSE ]

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparing the effectiveness of USG guided dextrose versus PRP in carpal tunnel syndrome

Scientific Title of Study

Comparing the effectiveness of ultrasound guided 5 percent dextrose prolotherapy versus platelet rich plasma in treatment of moderate to sever carpal tunnel syndrome- randomised control trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sumiya Begam U
Designation	Junior Resident
Affiliation	Tamil Nadu Dr MGR Medical University
Address	Government Institute of Rehabilitation Medicine Department of Physical Medicine and Rehabilitation Madras Medical College K K NAGAR CHENNAI Chennai TAMIL NADU 600083 India
Phone	7708038264
Fax
Email	sumiyajasmine786@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Thirunavukkarasu P
Designation	Director and HoD
Affiliation	Tamil Nadu Dr MGR Medical University
Address	Government Institute of Rehabilitation Medicine, Madras Medical College, KK nagar, Chennai Chennai TAMIL NADU 600083 India
Phone	9444367919
Fax
Email	arasupmr@gmail.com

Details of Contact Person
Public Query

Name	Dr Sumiya Begam U
Designation	Junior Resident
Affiliation	Tamil Nadu Dr MGR Medical University
Address	Government Institute of Rehabilitation Medicine Outpatient department of physical medicine and rehabilitation Madras Medical College K K NAGAR CHENNAI Chennai TAMIL NADU 600083 India
Phone	7708038264
Fax
Email	sumiyajasmine786@gmail.com

Source of Monetary or Material Support

Government Institute of Rehabilitation Medicine, K N agar, Chennai

Primary Sponsor

Name	NIL
Address	NIL
Type of Sponsor	Other [NIL]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sumiya Begam U	Government Institute of Rehabilitation Medicine	Outpatient department/room 1,2,3,4/Operation theatre KK NAGAR CHENNAI Chennai TAMIL NADU	7708038264 sumiyajasmine786@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Madras Medical College, Chennai- 600003	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G560\|\|Carpal tunnel syndrome,

Intervention / Comparator Agent

Type	Name	Details
Intervention	5 percent dextrose	Under USG guidance 5 ML of five percent dextrose in which 3ml to peel the nerve of the flexor retinaculum via hydrodissection and 2 ml injected into inferior part of medial nerve of the carpal tunnel
Comparator Agent	Platelet rich plasma	Under USG guidence single dose of 3 ml platelet rich plasma injected to Carpal Tunnel

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Moderate to severe carpal tunnel sydrome based on nerve conduction study with symptoms persisting for more than one month

ExclusionCriteria

Details

Polyneuropathy
Wrist surgery
Inflammatory arthritis
Hypothyroid
Pregnancy
Rheumatoid diseases
Diabetes mellitus
Trauma/Neoplasm/Infection at injection site

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
NUMERIC PAIN RATING SCALE	0, 1, 3, 6 months

Secondary Outcome

Outcome	TimePoints
BOSTON CARPAL TUNNEL QUESTIONNAIRE and NERVE CONDUCTION STUDY	0,1,3,6 months

Target Sample Size

Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

25/12/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy is thought to be caused by the compression of the median nerve as a result of excess pressure from surrounding tissues leading to nerve ischemia within the carpaltunnel.Therefore, applying a novel nonsurgical management is important and valuable during the presurgical stage in patients with CTS, especially those of moderate-to-severe grades. Perineural injection therapy is a technique involves the injection of 5% dextrose (osmolality similar to that of normal saline) solution near the peripheral nerve and has been found to provide promising pain-relief benefits. Platelet-rich plasma (PRP) is a biologic product of concentrated platelets; it contains several growth factors well known to be effective on inflammation and wound healing. 5% Dextrose and platelet-rich plasma (PRP) are the two most commonly used regenerative injection have shown their potential role in promoting tissue

repair.

AIM - To comparing the effectiveness of ultrasound guided 5% dextrose prolotherapy versus platelet rich plasma in treatment of moderate to severe carpal tunnel syndrome.