| CTRI Number |
CTRI/2018/03/012824 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Radial Nerve Involvement in Symptoms of Patients with Lateral Epicondylitis |
|
Scientific Title of Study
|
Ultrasonographic Evaluation of Radial Neuropathy in Patients with Lateral Epicondylitis and its Correlation with Pain and Functional Outcome Before and After Corticosteroid Injection into the Extensor Tendon |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhimanyu Vasudeva |
| Designation |
Senior Resident, Department of PMR, AIIMS, New Delhi |
| Affiliation |
Senior Resident, Department of PMR, AIIMS, New Delhi |
| Address |
Room number 10, Department of PMR, AIIMS, New Delhi
Room number 10, Department of PMR, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9910185126 |
| Fax |
|
| Email |
abhimanyu.vmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Handa |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 4, Department of PMR, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9899664489 |
| Fax |
|
| Email |
gitahanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhimanyu Vasudeva |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room number 10, Department of PMR, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9910185126 |
| Fax |
|
| Email |
abhimanyu.vmmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PMR, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
All India Institute of Medical Sciences(AIIMS), Ansari Nagar, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Abhimanyu Vasudeva |
AIIMS |
Room number 10, Department of PMR, AIIMS, New Delhi
South West
DELHI |
9910185126
abhimanyu.vmmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Post Graduate Research for Clinical Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with a clinical diagnosis of Lateral Epicondylitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative Treatment |
A set of conventional therapeutic exercises, massage and bracing |
| Intervention |
Methylprednisolone acetate(40mg/1ml) |
USG-Guided, local infiltration of 40 mg/1ml of methylprednisolone acetate near the insertion of extensor digitorum brevis alongwith a set of conventional therapeutic exercises, massage and bracing |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Diagnosis of Lateral epicondylitis |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of previous treatment for ipsilateral lateral epicondylitis, other elbow pathologies, cervical vertebrae/upper limb disorders, previous elbow surgery, joint limitations due to a previous radius/ulna fracture, osteoporosis, malignancy, hemophilia
2. Any clinical finding suggestive of peripheral nerve (ulnar, radial, median)
3. Mechanical symptoms ( locking, clicking, limited motion) of elbow including joint limitations following radius/ulna fracture
4.Local infection at site of injection or generalized infection
5. Refusal to participate in the study
6. Prior steroid injection in same elbow
7. Known allergy to steroid
8. History of trauma around elbow
9. Contraindication of steroid ( Uncontrolled Hypertension, Diabetes mellitus, Pregnancy)
10. Bilateral lateral epicondylitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare effect of a single dose ultrasound guided corticosteroid injection with conservative treatment on pain and function using quick-DASH in patients with lateral epicondylitis.
2. To compare effect of single dose ultrasound guided corticosteroid injection with conservative treatment on ultrasonographic measurement of the cross-sectional area of the radial nerve in patients with lateral epicondylitis |
0, 4 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare ultrasonographic measurement of cross-sectional area of the radial nerve before and after single dose ultrasound guided corticosteroid injection in patients with lateral epicondylitis ( on the affected and unaffected sides)
2. To correlate quick-DASH scores with ultrasonographic evaluation of the radial nerve in patients with lateral epicondylitis |
0, 4 and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
Modification(s)
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2018 |
| 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="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lateral epicondylitis is a common painful condition around the elbow which continues to perplex both the patient and practitioner due to inconsistent treatment options and outcomes. Although many non-operative and surgical options exist, there remains a general lack of consensus regarding optimal treatment. Corticosteroids are commonly used to treat lateral epicondylitis,however, the way in which they work is currently unknown. Findings of this study will evaluate the effect of steroid with conservative treatment on pain and functional outcome. Ultrasonographic evaluation of the radial nerve may support previous literature that some of the chronic complaints of these patients might actually be due to radial nerve entrapment. The hypothesis of the study is as follows : Single dose of ultrasound guided corticosteroid injection in the extensor tendon and conservative treatment shows no change on ultrasonographic measurement of the cross-sectional area of the radial nerve at the elbow and in the spiral groove in patients with lateral epiconylitis. |