| CTRI Number |
CTRI/2019/11/022136 [Registered on: 25/11/2019] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to determine whether the of injection of Ozone gas in to the hand under ultrasound guidance is reducing Pain and other hand symptoms of patients with carpal tunnel syndrome |
|
Scientific Title of Study
|
Effectiveness of ultrasound guided local ozone injection versus normal saline injection in the treatment of patients with carpal tunnel syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahin K E |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
9746067673 |
| Fax |
|
| Email |
13shahinerumb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof N Romi singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences,Imphal |
| Address |
Professor
Department of physical medicine and rehabilitation,Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
9436025822 |
| Fax |
|
| Email |
dr_romisingh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shahin K E |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
9746067673 |
| Fax |
|
| Email |
13shahinerumb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physical medicine and rehabilitation,Regional Institute of medical sciences,imphal |
|
|
Primary Sponsor
|
| Name |
Prof N Romi Singh |
| Address |
Professor
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences,
Lamphelpat, Imphal – 795004, Manipur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shahin K E |
Regional Institute of Medical Sciences,Imphal |
Department of Physical Medicine and Rehabilitation,
PMR Complex
Imphal West
MANIPUR |
9746067673
13shahinerumb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board,Regional Institute of Medical Sciences,Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local injection of Normal Saline |
Ultrasound guided local injection of 1 ml of Normal Saline in to the carpal tunnel once and follow up for 12 weeks |
| Intervention |
Local injection of Ozone gas |
Ultrasound guided local injection of 4 ml of ozone gas in to the carpal tunnel once and follow up for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of carpal tunnel syndrome and willingness to participate in the study and comply with treatment and follow up |
|
| ExclusionCriteria |
| Details |
Existence of disorders such as hypothyroidism,diabetes mellitus and rheumatoid arthritis
Cervical radiculopathy,polyneuropathy,peripheral nerve lesion in upper limb
Steroid injection with in 12 weeks or carpal tunnel surgery
Pregnant women
Glucose-6-phosphate Dehydrogenase deficiency
Thrombocytopenia,hyperthyroidism
Treatment with Angiotensin converting enzyme inhibitors
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain
2.Symptom severity
3.Functional status |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pain
2.Symptom severity
3.Functional status |
1.At 2 weeks
2.At 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/12/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, parallel group, placebo controlled trial comparing the effectiveness of local ozone injection versus normal saline injection in the treatment of carpal tunnel syndrome. 32 patients with carpal tunnel syndrome will be recruited from the OPD of physical medicine and rehabilitation department in RIMS. The primary outcome measures will be pain, symptom severity and functional status after 12 weeks. The secondary outcome will be pain, symptom severity and functional status at 2 weeks and 4 weeks. |