Lateral EpicondylitisNCT01109446
Treatment of Lateral Epicondylitis: Platelet Rich Plasma Versus Steroid Versus Saline Solution
A study testing Platelet Rich Plasma, Isotonic Saline Solutions and Triamcinolonacetonid in people with Lateral Epicondylitis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Platelet Rich Plasma, Isotonic Saline Solutions and Triamcinolonacetonid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Silkeborg Regional Hospital Department of Reumatology
Silkeborg, 8600
About this study
Official title: Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution
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.
Read the detailed description
Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.
- Conditions
- Lateral Epicondylitis
- Being tested
- Platelet Rich Plasma, Isotonic Saline Solutions, Triamcinolonacetonid
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Also called Plasma, Platelet Rich, PRP, Blood Platelets
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.
Isotonic Saline SolutionsProcedure or surgery
Also called Physiological Saline Solution
3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
TriamcinolonacetonidDrug
Also called Kenalog
Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma | Experimental | Not described Receives: Biological: Platelet Rich Plasma |
| Isotonoic Saline Solution | Sham comparator | Not described Receives: Procedure: Isotonic Saline Solutions |
| Steroid (Triamcinolonacetonid) | Active comparator | Not described Receives: Drug: Triamcinolonacetonid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first day, 1 months, 3 months, 6 months, 12 months.
Secondary outcomes (4)
Functional Disability
We use the PRTEE questionaire, validated for tennis elbow.
Measured: First day, 1 month, 3 months, 6 months, 12 months
Ultrasonographic changes
We meassure ultrasonographic changes in: tendon thickness and doppler activity.
Measured: first day, 1 months, 3 months, 6 months, 12 months
Adverse events
The number of adverse events leading to withdrawal
Measured: through out the entire 12 months
Pain induced by the treatment
A numeric scale 0-10 adressing if the treatment caused any aditional pain, and the duration: <1 week, 1-2 week, 3-4 weeks, > 4 weeks.
Measured: 1 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109446
- Sponsor's protocol ID
- PRP RCT
- Status last verified
- Feb 2012
- First submitted
- 21 Apr 2010
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lateral Epicondylitis. Platelet Rich Plasma vs. Steroid vs. Saline Solution
- ClinicalTrials.gov ID
- NCT01109446
- Acronym / sponsor ID
- PRP RCT
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Epicondylitis Lateralis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Plate Rich Plasma (PRP) is a new treatment for tendinopathy. A high concentration of blood platelets is made from the patients own blod, and then injected into the tendon. The idea is that the complex mixture of growth factors within the platelets can stimulate the healing process of the tendon. We want to address the efficacy and safety of this new treatment and compare it to either the best documented treatment, Steroid injection, or to a saline solution. We want to make a randomized controlled trial with 60 participants, 20 in each of the 3 groups, and a 12 months follow up. All injections are guided by ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma | Experimental | Biological: Platelet Rich Plasma |
| Isotonoic Saline Solution | Sham comparator | Procedure: Isotonic Saline Solutions |
| Steroid (Triamcinolonacetonid) | Active comparator | Drug: Triamcinolonacetonid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Inflammatory disease.
- Fibromyalgia.
- Pain in hand or shoulder/neck in the same arm as being treated.
- Anticoagulation treatment.
- Wounds around the elbow.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich PlasmaAlso: Plasma, Platelet Rich, PRP, Blood Platelets27ml 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. | Biological | Platelet Rich Plasma |
| Isotonic Saline SolutionsAlso: Physiological Saline Solution3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound. | Procedure or surgery | Isotonoic Saline Solution |
| TriamcinolonacetonidAlso: KenalogTriamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound. | Drug | Steroid (Triamcinolonacetonid) |
Primary outcome
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire.
Time frame: first day, 1 months, 3 months, 6 months, 12 months.
We use the PRTEE questionaire, which is validated for tennis elbow.
4 secondary outcomes
Functional Disability
Time frame: First day, 1 month, 3 months, 6 months, 12 months
Ultrasonographic changes
Time frame: first day, 1 months, 3 months, 6 months, 12 months
Adverse events
Time frame: through out the entire 12 months
Pain induced by the treatment
Time frame: 1 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma, Isotonic Saline Solutions and Triamcinolonacetonid in people with Lateral Epicondylitis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain as a continuous outcome measure. Using The Patient-Rated Tennis Elbow Evaluation (PRTEE) questionaire. (time frame: first day, 1 months, 3 months, 6 months, 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.