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

NCT00947765 | Completed Phase 2 Results DMC

• 1 other identifier: Lateralepicondylitis- ChetanMD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tennis Elbow; Epicondylitis, Lateral Humeral

Keywords

Tennis Elbow; Epicondylitis, Lateral Humeral

Outcome Measures

Primary Outcomes (8)

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

  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.

  1 week

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

  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

  1 week

• Pain(at 4 Weeks): Visual Analogue Scale

  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 weeks

• Pain(at 4 Weeks): Nirschl Staging

  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

  4 weeks

• Pain(at 12 Weeks): Visual Analogue Scale

  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.

  12 weeks

• Pain(at 12 Weeks): Nirschl Staging

  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

  12 weeks

• Pain(at 6 Months): Visual Analogue Scale

  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 months

• Pain(at 6 Months): Nirschl Staging

  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

  6 months

Study Arms (2)

Autologous blood injection group

EXPERIMENTAL

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

Biological: Autologous blood injection

Local corticosteroid injection group

ACTIVE COMPARATOR

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

Interventions

Autologous blood injection 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.

Also known as: autologous blood drawn from peripheral vein.

Autologous blood injection group

Local corticosteroid injection 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

Also known as: Methyl prednisolone acetate 80mg

Local corticosteroid injection group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dojode, Chetan M., MBBS, MS: lead

Study Sites (1)

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

Belagavi, Karnataka, 590010, India

Location

Related Publications (1)

• 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.

  PMID: 12671860 RESULT

Related Links

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

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Results Point of Contact

• Title: Dr. Chetan Muralidhara Rao Dojode, MBBS,MS(Ortho)
• Organization: Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.

docchetanmd@yahoo.co.in

91 9844592532

Study Officials

• 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)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 28, 2009
• Study Start: January 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 28, 2010
• Results First Posted: July 23, 2010

Record last verified: 2009-10

Locations

IN (1)