| CTRI Number |
CTRI/2019/10/021781 [Registered on: 23/10/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two treatment modalities, needle tenotomy and shock wave therapy of common tendon origin in the treatment of tennis elbow |
|
Scientific Title of Study
|
Comparison of ultrasound guided percutaneous needle tenotomy and extracorporeal shock wave therapy in reducing pain and functional disability in the management of recalcitrant lateral epicondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreejith C |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Physical Medicine and Rehabilitation department,
Regional Institute of Medical Sciences, imphal
Lamphelpat, Imphal, Manipur
pin-795004
Imphal West
MANIPUR
795004
India |
| Phone |
7907496573 |
| Fax |
|
| Email |
sreec50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akoijam Joy Singh |
| Designation |
Head of the Department |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Physical Medicine and Rehabilitation department,
Regional Institute of Medical Sciences, imphal
Lamphelpat, Imphal, Manipur
pin-795004
Imphal West
MANIPUR
795004
India |
| Phone |
7907496573 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreejith C |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Physical Medicine and Rehabilitation department,
Regional Institute of Medical Sciences, imphal
Lamphelpat, Imphal, Manipur
pin-795004
Imphal West
MANIPUR
795004
India |
| Phone |
7907496573 |
| Fax |
|
| Email |
sreec50@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sreejith C |
| Address |
Physical Medicine and Mehabilitation department, RIMS ,Imphal |
| 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 |
| Sreejith C |
Regional Institute of Medical Sciences |
Department of Physical Medicine and Rehabilitation,RIMS, Imphal-795004
Imphal West
MANIPUR |
7907496573
sreec50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M771||Lateral epicondylitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Extracorporeal shock wave therapy |
A total of 2000 impulses at a frequency of 6Hz will be given at the maximum tender point of common extensor origin, once weekly for 3 weeks |
| Intervention |
Needle tenotomy |
ultrasound guided percutaneous needle tenotomy of abnormal tendon of common extensor origin with a 20-gauge,1.5 to 3 inch needle .With real-time sonographic imaging for continous guidance approximately 20 to 30 needle passes will be made through the abnormal region of the tendon so that entire abnormal region of tendon is repeatedly fenestrated . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of resistant lateral epicondylosis
2.Pain severity with minimum score of 5 based on 10 scale VAS
3.Willingness to comply with treatment and follow up assessment |
|
| ExclusionCriteria |
| Details |
1.Any recent febrile or infectious disease
2.History of any malignancy or autoimmune disease
3.Peripheral nerve injuries
4.Systemic illness including ischemic heart disease, HIV
5.Treatment with anticoagulant or anti-platelet within 10 days of procedure
6.Haemoglobin less than 10 g/dl
7.Pregnancy
8.Cardiac arrhythmia or pace makers
9.Received cortico steroid injection within the previous 12 weeks
10.Allergy to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Visual Analogue Scale (VAS) for pain
2.Patent Rated Tennis Elbow Evaluation (PRTEE)
|
1.4 weeks, 12 weeks and 24 weeks
2.4 weeks, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grip strength |
4 weeks, 12 weeks and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
26/10/2019 |
| 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="1"
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 is a single blinded randomized controlled trial comparing the efficacy of ultrasound guided percutaneous needle tenotomy and extracorporeal shock wave therapy in reducing pain and functional disability in the management of lateral epicondylosis in 82 patients that will be conducted in one center in India for 1 year of duration.The primary outcome measures will be Visual Analogue Scale, Patient Rated Tennis Elbow Evaluation at 4 weeks, 12 weeks and 24 weeks.Secondary outcome measure will be Grip strength measured at 4 weeks, 12 weeks and 24 weeks |