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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by McMaster University
Sponsor:
Collaborators:
Arthrex, Inc.
The Physicians' Services Incorporated Foundation
Radiological Society of North America
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01668953
First received: August 16, 2012
Last updated: September 15, 2014
Last verified: September 2014

August 16, 2012
September 15, 2014
August 2012
January 2017   (final data collection date for primary outcome measure)
Pain Reduction [ Time Frame: Baseline, 6 weeks, 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).
  • 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.
Complete list of historical versions of study NCT01668953 on ClinicalTrials.gov Archive Site
  • Functional Disability [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Functional disability will be measured using the Liverpool Elbow Score (LES) 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: Baseline, 6 weeks, 3, 6, 12, 24 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: Baseline, 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
    Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).
  • 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).
Not Provided
Not Provided
 
Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)
Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis

"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 attempted, 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 non-affected 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 (platelet rich plasma) is a newer, but expensive, technique.

At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.

The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Lateral Epicondylitis (Tennis Elbow)
  • Other: Platelet Rich Plasma (PRP) Injection
    1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
    2. A 22-gauge needle will then be placed into the tendon followed by 15-25 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. Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.
    5. The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
  • Other: Whole Blood Injection
    1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
    2. A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
    3. 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.
    4. Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.
    5. The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
  • Other: Dry Needle Fenestration
    1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine 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. A 22-gauge needle will then be placed into the tendon.
    4. 15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon.
  • Other: Sham Injection
    1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) 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.
  • Experimental: Platelet Rich Plasma (PRP) Injection
    Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
    Intervention: Other: Platelet Rich Plasma (PRP) Injection
  • Active Comparator: Whole Blood Injection
    Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.
    Intervention: Other: Whole Blood Injection
  • Active Comparator: Dry Needle Fenestration
    Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
    Intervention: Other: Dry Needle Fenestration
  • Placebo Comparator: Sham Injection
    Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.
    Intervention: Other: Sham Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult man or woman aged 18 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 based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture.
  • 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 2 months).
  • History of acute elbow trauma (less than one week).
  • History of rheumatoid arthritis.
  • History of malignancy.
  • Pregnancy
  • Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
  • 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).
Both
18 Years and older
No
Contact: Mary M Chiavaras, MD, PhD 905-521-2100 ext 46521 meg.chiavaras@gmail.com
United States,   Canada
 
NCT01668953
IMPROVE-001, Research Seed Grant # 1204
Yes
McMaster University
McMaster University
  • Arthrex, Inc.
  • The Physicians' Services Incorporated Foundation
  • Radiological Society of North America
Principal Investigator: Mary M Chiavaras, MD, PhD McMaster University
McMaster University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP