CompletedPhase 2/3

A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis

India60 participantsStarted 2007-01

Plain-language summary

Lateral epicondylitis, is a common problem encountered in the orthopaedic practice. Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. Beneficial effects of local corticosteroid infiltration have sound lack of scientific rationale, since surgical specimens show lack of any inflammatory process. Recently an injection of "autologous blood injection" has been reported to be effective for both intermediate and long term outcomes. It is hypothesized that blood contains platelet derived growth factor induce fibroblastic mitosis and chemotactic polypeptides such as transforming growth factor cause fibroblasts to migrate and specialize and have been found to induce healing cascade. The objective of the study is to evaluate the efficacy of autologous blood injection versus local corticosteroid injection in the management of lateral epicondylitis.

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cases of lateral epicondylitis.
. Men and women above fifteen years of age.

Exclusion criteria

. Patients receiving steroid injections within three months before blood injection.
. A history of substantial trauma.
. Previously treated by surgery for lateral epicondylitis.
. Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain (at 1 Week): Visual Analogue Scale(0 to 10)

Timeframe: 1 week

Pain(at 1 Week): Nirschl Staging (0 to 7)

Timeframe: 1 week

Pain(at 4 Weeks): Visual Analogue Scale

Timeframe: 4 weeks

Pain(at 4 Weeks): Nirschl Staging

Timeframe: 4 weeks

Pain(at 12 Weeks): Visual Analogue Scale

Timeframe: 12 weeks

Pain(at 12 Weeks): Nirschl Staging

Timeframe: 12 weeks

Pain(at 6 Months): Visual Analogue Scale

Timeframe: 6 months

Pain(at 6 Months): Nirschl Staging

Timeframe: 6 months

Trial details

NCT IDNCT00947765

SponsorDojode, Chetan M., MBBS, MS

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2008-06

Results submitted2010-05-27

View on ClinicalTrials.gov More Tennis Elbow trials

Plain-language summary

Who can participate

Age range

15 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cases of lateral epicondylitis.
. Men and women above fifteen years of age.

Exclusion criteria

. Patients receiving steroid injections within three months before blood injection.
. A history of substantial trauma.
. Previously treated by surgery for lateral epicondylitis.
. Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.

What they're measuring

Pain (at 1 Week): Visual Analogue Scale(0 to 10)

Timeframe: 1 week

Pain(at 1 Week): Nirschl Staging (0 to 7)

Timeframe: 1 week

Pain(at 4 Weeks): Visual Analogue Scale

Timeframe: 4 weeks

Pain(at 4 Weeks): Nirschl Staging

Timeframe: 4 weeks

Pain(at 12 Weeks): Visual Analogue Scale

Timeframe: 12 weeks

Pain(at 12 Weeks): Nirschl Staging

Timeframe: 12 weeks

Pain(at 6 Months): Visual Analogue Scale

Timeframe: 6 months

Pain(at 6 Months): Nirschl Staging

Timeframe: 6 months