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
Results First Received: May 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Tennis Elbow
Epicondylitis, Lateral Humeral
Interventions: Biological: Autologous blood injection
Drug: Local corticosteroid injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Participants were selected by interview and clinical examination and Consent was taken.

Location: Out patient department of KLES Dr. Prabhakar Kore Hospital & MRC, Belgaum.

Period: January 1st, 2007–December 31st, 2007. No blinding procedure was followed. Randomization: participants were assigned into two groups according to randomization table.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Autologous Blood Injection Group This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
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.

Participant Flow:   Overall Study
    Autologous Blood Injection Group     Local Corticosteroid Injection Group  
STARTED     30     30  
COMPLETED     30     30  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Autologous Blood Injection Group This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
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.
Total Total of all reporting groups

Baseline Measures
    Autologous Blood Injection Group     Local Corticosteroid Injection Group     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     28     29     57  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  42.9  ± 12.7721     42.3  ± 9.51     42.6  ± 11.1678  
Gender  
[units: participants]
     
Female     17     18     35  
Male     13     12     25  
Region of Enrollment  
[units: participants]
     
India     30     30     60  
Laterality of limb involved [1]
[units: participants]
     
Participants with Right limb involved     23     23     46  
Participants with Left limb involved     7     7     14  
Participants with Dominant and Non-Dominent limb involvement [2]
[units: participants]
     
Participants with Dominent limb involved     25     26     51  
Participants with Non-Dominant limb involved     5     4     9  
Pain: Nirschl Staging (0 to 7) [3]
[units: Units on a scale]
Mean ± Standard Deviation
  5.4  ± 1.1325     5.23  ± 0.9714     5.315  ± 1.049  
Pain: Visual Analogue Scale (0 to 10) [4]
[units: Units on a scale]
Mean ± Standard Deviation
  7.7  ± 1.3429     7.533  ± 1.2794     7.616  ± 1.303  
[1] Participants with Right limb involved / Participants with Left limb involved
[2] Participants with Dominant limb involved / Participants with Non-Dominent limb involved
[3]

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]

PAIN SCORE; 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.




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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Chetan Muralidhara Rao Dojode, MBBS,MS(Ortho)
Organization: Dr. Chetan Muralidhara Rao Dojode. Resident in Orthopaedics and Traumatology.
phone: 91 9844592532
e-mail: docchetanmd@yahoo.co.in


Publications of Results:

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