Clinical trial NCT00947765: A Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis
Official title: Phase 2/Phase 3 of the Randomized Control Trial to Evaluate the Efficacy of Autologous Blood Injection Versus Local Corticosteroid Injection for Treatment of Lateral Epicondylitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tennis Elbow
Epicondylitis, Lateral Humeral
Keywords: Tennis Elbow
Epicondylitis, Lateral Humeral
Lead sponsor: Dojode, Chetan M., MBBS, MS
Sponsor class: INDIV
First posted: 2009-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain (at 1 Week): Visual Analogue Scale(0 to 10)
timeFrame: 1 week
measure: Pain(at 1 Week): Nirschl Staging (0 to 7)
timeFrame: 1 week
measure: Pain(at 4 Weeks): Visual Analogue Scale
timeFrame: 4 weeks
measure: Pain(at 4 Weeks): Nirschl Staging
timeFrame: 4 weeks
measure: Pain(at 12 Weeks): Visual Analogue Scale
timeFrame: 12 weeks
measure: Pain(at 12 Weeks): Nirschl Staging
timeFrame: 12 weeks
measure: Pain(at 6 Months): Visual Analogue Scale
timeFrame: 6 months
measure: Pain(at 6 Months): Nirschl Staging
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgaum.
country: India
facility: Jawaharlal Nehru Medical College. KLES Dr.Prabhakar Kore Hospital and Medical Research Center.
state: Karnataka
Study officials:
affiliation: Professor of Orthopaedics. Jawaharlal Nehru Medical College. Belgaum. Karnataka. India.
name: Dr. Vijay kumar G Murakibhavi, MS(Ortho)
role: STUDY_CHAIR
affiliation: Senior Resident (Dept. of Orthopaedic and Traumatology)
name: Dr. Chetan M Dojode, MBBS,MS(Ortho)
role: STUDY_CHAIR
References:
citation: 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.