Phase 3
N=60
A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis
Tennis Elbow · Epicondylitis, Lateral Humeral
Bottom Line
View on ClinicalTrials.gov: NCT00947765 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Jul 2010
Primary outcome: Primary: Pain (at 1 Week): Visual Analogue Scale(0 to 10) — 7.166; 4.5 Units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Autologous blood injection (Biological); Local corticosteroid injection (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Dojode, Chetan M., MBBS, MS
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain (at 1 Week): Visual Analogue Scale(0 to 10) |
7.166; 4.5 | <0.0001 sig |
| PRIMARY Pain(at 1 Week): Nirschl Staging (0 to 7) |
5.1; 3.06 | <0.0001 sig |
| PRIMARY Pain(at 4 Weeks): Visual Analogue Scale |
3.2; 1.533 | 0.0022 sig |
| PRIMARY Pain(at 4 Weeks): Nirschl Staging |
2.2; 1.03 | 0.003 sig |
| PRIMARY Pain(at 12 Weeks): Visual Analogue Scale |
0.6; 1.5 | 0.0127 sig |
| PRIMARY Pain(at 12 Weeks): Nirschl Staging |
0.433; 1.03 | 0.0184 sig |
| PRIMARY Pain(at 6 Months): Visual Analogue Scale |
0.533; 1.833 | 0.0058 sig |
| PRIMARY Pain(at 6 Months): Nirschl Staging |
0.366; 1.233 | 0.0064 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00947765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.