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

This study has been completed.
Sponsor:
Information provided by:
Dojode, Chetan M., MBBS, MS
ClinicalTrials.gov Identifier:
NCT00947765
First received: July 27, 2009
Last updated: July 27, 2010
Last verified: October 2009
  Purpose

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 Intervention Phase
Tennis Elbow
Epicondylitis, Lateral Humeral
Biological: Autologous blood injection
Drug: Local corticosteroid injection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dojode, Chetan M., MBBS, MS:

Primary Outcome Measures:
  • Pain (at 1 Week): Visual Analogue Scale(0 to 10) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

    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.


  • Pain(at 1 Week): Nirschl Staging (0 to 7) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

    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


  • Pain(at 4 Weeks): Visual Analogue Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Pain(at 4 Weeks): Nirschl Staging [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

    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


  • Pain(at 12 Weeks): Visual Analogue Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    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.


  • Pain(at 12 Weeks): Nirschl Staging [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    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


  • Pain(at 6 Months): Visual Analogue Scale [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.


  • Pain(at 6 Months): Nirschl Staging [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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



Enrollment: 60
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00947765

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:
Publications:
Responsible Party: Dr. Chetan Muralidhara Rao Dojode, MBBS,MS(Ortho), Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.
ClinicalTrials.gov Identifier: NCT00947765     History of Changes
Other Study ID Numbers: Lateralepicondylitis- ChetanMD
Study First Received: July 27, 2009
Results First Received: May 27, 2010
Last Updated: July 27, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Dojode, Chetan M., MBBS, MS:
Tennis Elbow
Epicondylitis, Lateral Humeral

Additional relevant MeSH terms:
Tennis Elbow
Arm Injuries
Musculoskeletal Diseases
Wounds and Injuries
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014