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Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE)

This study is currently recruiting participants.
Verified May 2013 by McMaster University
Sponsor:
Collaborator:
Radiological Society of North America
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01668953
First received: August 16, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.

Many treatments have been tried, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (PRP) is a newer, but expensive, technique.

At this point, It is unclear whether whole blood, concentrated platelets, or simply causing the tendon to bleed by making a few small holes (tendon fenestration) is the better treatment.

The goal of this study is to perform a study comparing these three different treatments to identify the best, and most cost-effective therapy, for this debilitating condition.


Condition Intervention
Lateral Epicondylitis (Tennis Elbow)
 Other: Platelet Rich Plasma (PRP)
Other: Whole Blood Injection
Other: Dry Needle Fenestration
Other: No Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Rate of recruitment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Ability to recruit 60 patients over a 12 month period.

  • Adherence to study protocol [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Adherence to the study protocol will be measured by the proportion of included patients followed at 1 year, the proportion of data forms completed at 1 year, the number of errors made in randomization and the number of crossovers.


Secondary Outcome Measures:
  • Pain Reduction [ Time Frame: 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).

  • Functional Disability [ Time Frame: 0, 1,2,3,6,12 months ] [ Designated as safety issue: No ]
    Functional disability will be measured using Liverpool elbow score which is an assessment tool for evaluating function based on range of motion, ulnar nerve function and ability to perform daily activities.

  • Psychological Impairment [ Time Frame: 0, 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression.

  • Health-Related Quality of Life [ Time Frame: 0, 1, 2, 3, 6, 12 ] [ Designated as safety issue: No ]
    Quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Platelet Rich Plasma (PRP) Injection
Patients in this arm will be injected with platelet rich plasma at the site of their lateral epicondylitis.
 Other: Platelet Rich Plasma (PRP)
  1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 5 ml of lidocaine 1% for local anesthetic.
  2. A 22-gauge needle will then be placed into the tendon followed by 10-12 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
  3. For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used.
  4. 3mL of PRP will be placed into the common extensor tendon.
  5. The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
Active Comparator: Whole Blood Injection
Patients in this arm will be injected with whole blood at the site of their lateral epicondylitis.
 Other: Whole Blood Injection
  1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 5 ml of lidocaine 1% for local anesthetic.
  2. A 22-gauge needle will then be placed into the tendon followed by 10-12 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.

2. 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and 3mL placed into the common extensor tendon.

3. The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
Active Comparator: Dry Needle Fenestration
Patients in this arm will be injected with Marcaine at the site of their lateral epicondylitis and will also receive 10-12 gentle strokes of dry needling (piercing of the tendon). No blood will be injected into the tendon.
 Other: Dry Needle Fenestration
  1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 5 ml of lidocaine 1% for local anesthetic.
  2. A 22-gauge needle will then be placed into the tendon.
  3. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
  4. 10-12 gentle strokes of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon.
Placebo Comparator: No Injection
Patients in this arm will be injected with Marcaine at the site of their lateral epicondylitis.
 Other: No Injection
  1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 5 ml of lidocaine 1% for local anesthetic.
  2. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
  3. The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult man or woman aged 20 years or greater.
  • Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension.
  • Documented sonographic diagnosis of common extensor tendinosis and possible tear based on abnormal echotexture (tendon thickening, anechoic areas, areas of hypoechogencicity, loss of fibrillar pattern).
  • Chronic symptoms (equal or greater than 3 months).
  • Pain of at least 5 out of 10 on a visual analog scale (VAS).
  • Provision of informed consent.

Exclusion Criteria:

  • Acute symptom onset (less than 3 months).
  • History of acute elbow trauma.
  • History of rheumatoid arthritis.
  • History of malignancy.
  • Is the patient pregnant or does the patient plan on becoming pregnant?
  • Patient requires anti-platelet medication for the treatment of heart attack, stroke or other medical conditions.
  • Previous surgery for lateral epicondylitis.
  • Previous local injections, including steroids within the past 6 months.
  • Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).
  • Likely problems, in the judgment of the investigator, with maintaining follow-up?
  • Previous randomization in this study or a competing study?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668953

Contacts
Contact: Mary Chiavaras, MD, PhD 905-521-2100 ext 46521 meg.chiavaras@gmail.com

Locations
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Marilyn Swinton     9055274322     swinton@mcmaster.ca    
Principal Investigator: Meg Chiavaras, MD            
Sponsors and Collaborators
McMaster University
Radiological Society of North America
Investigators
Principal Investigator: Meg Chiavaras, PhD, MD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01668953     History of Changes
Other Study ID Numbers: IMPROVE-001, Research Seed Grant # 1204
Study First Received: August 16, 2012
Last Updated: May 15, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Lateral Epicondylitis
Tennis Elbow
Platelet Rich Plasma
Whole Blood
Tendon Fenestration

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013