Lateral Epicondylitis (Tennis Elbow)IMPROVENCT01668953
Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)
A study testing Platelet Rich Plasma (PRP) Injection, Whole Blood Injection and Dry Needle Fenestration in people with Lateral Epicondylitis (Tennis Elbow), run by McMaster University at 2 sites in 2 countries.
Trial summary
"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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Platelet Rich Plasma (PRP) Injection, Whole Blood Injection and Dry Needle Fenestration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2012to Apr 2023
- 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
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-5326
About this study
Official title: 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.
Read more
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.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Platelet Rich Plasma (PRP) Injection, Whole Blood Injection, Dry Needle Fenestration, Sham Injection
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Platelet Rich Plasma, Whole Blood, Tendon Fenestration
- 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 Plasma (PRP) InjectionOther
- The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
- 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.
- 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.
- Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.
- The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations.
Whole Blood InjectionOther
- The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
- 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.
- 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.
- Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.
- The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations.
Dry Needle FenestrationOther
- The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
- 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
- A 22-gauge needle will then be placed into the tendon.
- 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.
Sham InjectionOther
- The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.
- 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
- The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma (PRP) Injection | Experimental | 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. Receives: Other: Platelet Rich Plasma (PRP) Injection |
| Whole Blood Injection | Active comparator | Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. Receives: Other: Whole Blood Injection |
| Dry Needle Fenestration | Active comparator | 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. Receives: Other: Dry Needle Fenestration |
| Sham Injection | Placebo comparator | Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon. Receives: Other: Sham Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
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).
Measured: Baseline, 6 weeks, 3, 6, 12 months
Secondary outcomes (3)
Functional Disability
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.
Measured: Baseline, 6 weeks, 3, 6, 12, 24 months
Psychological Impairment
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.
Measured: Baseline, 6 weeks, 3, 6, 12, 24 months
Health-Related Quality of Life
Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).
Measured: Baseline, 6 weeks, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2023
- Study completionApr 2023
Why it stopped: Did not analyze data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc., The Physicians' Services Incorporated Foundation, Radiological Society of North America
- Responsible party
- Sponsor
- Investigators
- Mary M Chiavaras, MD, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668953
- Sponsor's protocol ID
- IMPROVE-001
- Other IDs
- Research Seed Grant # 1204
- Acronym
- IMPROVE
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2012
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.
PubMed 34590307
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT01668953
- Acronym / sponsor ID
- IMPROVE / IMPROVE-001
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Lateral Epicondylitis, Tennis Elbow, Platelet Rich Plasma, Whole Blood, Tendon Fenestration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not analyze data
- Enrolment
- 100 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Arthrex, Inc., The Physicians' Services Incorporated Foundation, Radiological Society of North America
- Study start
- Aug 2012
- Primary completion
- Apr 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 20 Aug 2012 (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.
"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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma (PRP) Injection | Experimental | Other: Platelet Rich Plasma (PRP) InjectionPatients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. |
| Whole Blood Injection | Active comparator | Other: Whole Blood InjectionPatients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. |
| Dry Needle Fenestration | Active comparator | Other: Dry Needle FenestrationPatients 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. |
| Sham Injection | Placebo comparator | Other: Sham InjectionPatients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- Acute symptom onset (less than 2 months).
- History of acute elbow trauma (less than one week).
- History of rheumatoid arthritis.
- History of malignancy.
- Pregnancy
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 Plasma (PRP) Injection1. 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 | Platelet Rich Plasma (PRP) Injection |
| Whole Blood Injection1. 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 | Whole Blood Injection |
| Dry Needle Fenestration1. 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 | Dry Needle Fenestration |
| Sham Injection1. 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. | Other | Sham Injection |
Primary outcome
Pain Reduction
Time frame: Baseline, 6 weeks, 3, 6, 12 months
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).
3 secondary outcomes
Functional Disability
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
Psychological Impairment
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
Health-Related Quality of Life
Time frame: Baseline, 6 weeks, 3, 6, 12, 24 months
Results and safety
The study was stopped early (reason given: Did not analyze data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 34590307Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.
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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.
Mary M Chiavaras, MD, PhD principal investigator
McMaster University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma (PRP) Injection, Whole Blood Injection and Dry Needle Fenestration in people with Lateral Epicondylitis (Tennis Elbow), run by McMaster University at 2 sites in 2 countries.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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 was stopped early (reason given: Did not analyze data). Results are not available in the source record.
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?
Pain Reduction (time frame: Baseline, 6 weeks, 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668953, which also lists 1 linked publication.
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 10 Apr 2023.