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

NCT ID: NCT00947765

Last Updated: 2010-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-06-30

Brief 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.

Detailed Description

Much controversy has been there over the pathophysiology and there is not enough scientific evidence to favour any particular type of treatment for acute lateral epicondylitis. Currently degeneration of the origin of the extensor carpi radialis brevis (ECRB), repeated micro trauma and incomplete healing response has been accepted as the cause of lateral epicondylitis by most of the researchers.

Histopathological reports have shown that lateral epicondylitis is not an inflammatory process but a degenerative condition termed 'tendinosis'. There are numerous treatment modalities for lateral epicondylitis both conservative and operative. Most conservative modalities such as local corticosteroid injection have focused on suppressing inflammatory process that does not actually exist. A recent review article concluded that for short term outcomes (6 weeks), statistically significant and clinically relevant differences were found on pain and global improvement with corticosteroid injection compared to placebo, local anaesthetic, or other conservative treatments. For intermediate (6 weeks to 6 months) and long term outcomes (more than 6 months), no statistically significant or clinically relevant results in favour of corticosteroid injections were found. So it is not possible to draw a firm conclusion on the effectiveness of corticosteroid injection.

Recently an injection of autologous blood has been reported to be effective for both intermediate and long term outcomes for the treatment of lateral epicondylitis. There was a significant decrease in pain. It is hypothesized that mitogens such as 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 cause angiogenesis. A specific humoral mediator may promote the healing cascade in the treatment of tendinosis as well. These growth factors trigger stem cell recruitment, increase local vascularity and directly stimulate the production of collagen by tendon sheath fibroblasts.

Autologous blood was selected as the medium for injection because (1) its application is minimally traumatic, (2) it has a reduced risk for immune-mediated rejection, devoid of potential complications such as hypoglycemia, skin atrophy, tendon tears associated with corticosteroid injection (3) it is simple to acquire and prepare, easy to carry out as outpatient procedure and (4) it is inexpensive.

There are very few studies done to evaluate injection of autologous blood for lateral epicondylitis as treatment modality. Hence it is evaluated by comparing with the corticosteroid injection which is a commonly practiced conservative treatment modality.

Conditions

Tennis Elbow; Epicondylitis, Lateral Humeral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous blood injection group

This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.

Group Type: EXPERIMENTAL

Autologous blood injection

Intervention Type: BIOLOGICAL

Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique.

Local corticosteroid injection group

This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.

Group Type: ACTIVE_COMPARATOR

Local corticosteroid injection

Intervention Type: DRUG

Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique

Interventions

Autologous blood injection

Patients were infiltrated with injection of 2 ml autologous blood drawn from contra lateral upper limb vein mixed with 1 ml 0.5% bupivacaine, at the lateral epicondyle according to the standard technique.

Intervention Type: BIOLOGICAL

Local corticosteroid injection

Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle according to the standard technique

Intervention Type: DRUG

Other Intervention Names

autologous blood drawn from peripheral vein.; Methyl prednisolone acetate 80mg

Eligibility Criteria

Inclusion Criteria

1. Cases of lateral epicondylitis.

2. Men and women above fifteen years of age.

Exclusion Criteria

1. Patients receiving steroid injections within three months before blood injection.

2. A history of substantial trauma.

3. Previously treated by surgery for lateral epicondylitis.

4. 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dojode, Chetan M., MBBS, MS

INDIV

Sponsor Role: lead

Responsible Party

Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.

Principal Investigators

Dr. Vijay kumar G Murakibhavi, MS(Ortho)

Role: STUDY_CHAIR

Professor of Orthopaedics. Jawaharlal Nehru Medical College. Belgaum. Karnataka. India.

Dr. Chetan M Dojode, MBBS,MS(Ortho)

Role: STUDY_CHAIR

Senior Resident (Dept. of Orthopaedic and Traumatology)

Locations

Jawaharlal Nehru Medical College. KLES Dr.Prabhakar Kore Hospital and Medical Research Center.

Belagavi, Karnataka, India

Countries

India

References

Edwards SG, Calandruccio JH. Autologous blood injections for refractory lateral epicondylitis. J Hand Surg Am. 2003 Mar;28(2):272-8. doi: 10.1053/jhsu.2003.50041.

Reference Type: RESULT

PMID: 12671860 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/16552606

Sonographic-guided blood injection has been reported to improve clinical outcome. It can also be used to monitor the changes to the common extensor origin

http://www.ncbi.nlm.nih.gov/pubmed/15779147

Autologous preparations rich in growth factors promote proliferation and induce VEGF and HGF production by human tendon cells in culture.

Other Identifiers

Lateralepicondylitis- ChetanMD

Identifier Type: -

Identifier Source: org_study_id