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

• ClinicalTrials.gov Identifier: NCT00947765
• Recruitment Status: Completed
• First Posted: July 28, 2009
• Results First Posted: July 23, 2010
• Last Update Posted: July 28, 2010
• Sponsor: Dojode, Chetan M., MBBS, MS
• Information provided by: Dojode, Chetan M., MBBS, MS

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tennis Elbow; Epicondylitis, Lateral Humeral	Biological: Autologous blood injection; Drug: Local corticosteroid injection	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: January 2007
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: June 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Autologous blood injection group; This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.	Biological: 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.; Other Name: autologous blood drawn from peripheral vein.
Active Comparator: 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.	Drug: 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; Other Name: Methyl prednisolone acetate 80mg

Outcome Measures

Primary Outcome Measures :

1. Pain (at 1 Week): Visual Analogue Scale(0 to 10) [ Time Frame: 1 week ]

   VISUAL ANALOGUE SCALE:

   Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.

   No pain____1___2___3___4___5___6___7___8___9___10 worst pain ever.

2. Pain(at 1 Week): Nirschl Staging (0 to 7) [ Time Frame: 1 week ]

   NIRSCHL STAGING:

   phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps

   No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain

3. Pain(at 4 Weeks): Visual Analogue Scale [ Time Frame: 4 weeks ]

   VISUAL ANALOGUE SCALE:

   Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.

   No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.

4. Pain(at 4 Weeks): Nirschl Staging [ Time Frame: 4 weeks ]

   NIRSCHL STAGING:

   phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps

   No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain

5. Pain(at 12 Weeks): Visual Analogue Scale [ Time Frame: 12 weeks ]

   VISUAL ANALOGUE SCALE:

   Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.

   No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.

6. Pain(at 12 Weeks): Nirschl Staging [ Time Frame: 12 weeks ]

   NIRSCHL STAGING:

   phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps

   No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain

7. Pain(at 6 Months): Visual Analogue Scale [ Time Frame: 6 months ]

   VISUAL ANALOGUE SCALE:

   Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, 1, 4, 12weeks and 6 month of follow-ups. Numerical valve is then given to it simply by measuring length between "no pain" to patients mark.

   No pain____1 ___ 2 ___ 3 ___ 4 ___ 5 ___ 6 ___ 7 ___ 8 ___ 9 ___ 10 worst pain ever.

8. Pain(at 6 Months): Nirschl Staging [ Time Frame: 6 months ]

   NIRSCHL STAGING:

   phase1: mild pain with exercise; resolves within 24 hours phase2: pain after exercise; exceeds 48 hours phase3: pain with exercise; does not alter activity phase4: pain with exercise; alters activity phase5: pain with heavy activities of daily living phase6: pain with light activities of daily living; intermittent pain at rest phase7: constant pain at rest; disrupts sleeps

   No pain______1 ______ 2______ 3_______4______ 5______ 6 _____ 7 worst pain

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

India

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

Belgaum., Karnataka, India, 590010

Sponsors and Collaborators

Dojode, Chetan M., MBBS, MS

Investigators

• Study Chair: Dr. Vijay kumar G Murakibhavi, MS(Ortho); Professor of Orthopaedics. Jawaharlal Nehru Medical College. Belgaum. Karnataka. India.
• Study Chair: Dr. Chetan M Dojode, MBBS,MS(Ortho); Senior Resident (Dept. of Orthopaedic and Traumatology)

More Information

Additional Information:

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 

this meta analysis concluded that there was insufficient scientific evidence for any particular type of treatment for lateral epicondylitis. 

Pooled analysis indicated corticosteroid injection showed short-term effectiveness only (2-6 weeks). At longer term follow up (>6 weeks) no difference between corticosteroid injection and other treatments including placebo. 

study showed no conclusiveness on the effectiveness of corticosteroid injections, due to the lack of high quality studies. No beneficial effects were found for intermediate or long-term follow-up. 

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

Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. 

Publications of Results:

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

• Responsible Party: Dr. Chetan Muralidhara Rao Dojode, MBBS,MS(Ortho), Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.
• ClinicalTrials.gov Identifier: NCT00947765
• Other Study ID Numbers: Lateralepicondylitis- ChetanMD
• First Posted: July 28, 2009
• Results First Posted: July 23, 2010
• Last Update Posted: July 28, 2010
• Last Verified: October 2009

Keywords provided by Dojode, Chetan M., MBBS, MS:

Tennis Elbow; Epicondylitis, Lateral Humeral

Additional relevant MeSH terms:

Tennis Elbow; Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Arm Injuries; Wounds and Injuries; Tendon Injuries; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Neuroprotective Agents; Protective Agents