Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution
1 other identifier
interventional
60
1 country
1
Brief Summary
We wish to address the efficacy and safety of Platelet Rich Plasma (blood platelets), a new treatment for lateral epicondylitis (tennis elbow) and compare this new treatment to either injection with steroid or saline solution. All injections are guided by ultrasonography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 14, 2012
February 1, 2012
2.7 years
April 21, 2010
February 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
We use the PRTEE questionaire, which is validated for tennis elbow.
first day, 1 months, 3 months, 6 months, 12 months.
Secondary Outcomes (4)
Functional Disability
First day, 1 month, 3 months, 6 months, 12 months
Ultrasonographic changes
first day, 1 months, 3 months, 6 months, 12 months
Adverse events
through out the entire 12 months
Pain induced by the treatment
1 months after treatment
Study Arms (3)
Platelet Rich Plasma
EXPERIMENTALIsotonoic Saline Solution
SHAM COMPARATORSteroid (Triamcinolonacetonid)
ACTIVE COMPARATORInterventions
27ml of autologous whole blood added to 3ml of ACD-A (Citrate Anticoagulant). After separation of the platelets, a high concentration of platelets (3-4ml Platelet Rich Plasma) is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
Eligibility Criteria
You may qualify if:
- Duration of tennis elbow \> 6 months
- Doppler activity on ultrasonography
- Lateral elbow pain that is maximal over the lateral epicondyle, and increases with pressure on the lateral epicondyle, and resisted dorsiflexion and/or middle finger.
You may not qualify if:
- Inflammatory disease.
- Fibromyalgia.
- Pain in hand or shoulder/neck in the same arm as being treated.
- Anticoagulation treatment.
- Wounds around the elbow.
- Treatment with steroids within the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Silkeborg Regional Hospital Department of Reumatology
Silkeborg, 8600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 23, 2010
Study Start
January 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 14, 2012
Record last verified: 2012-02