Tennis ElbowNCT02755727
Platelet Rich Plasma vs Open Surgery in the Treatment of Tennis Elbow
A study testing Platelet Rich Plasma Injection and Open Surgical Release in people with Tennis Elbow, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with repetitive use of the forearm extensor muscles. Though often self-limiting in nature there are a proportion of patients who fail to respond to conservative treatments such as rest, activity modification, physiotherapy and the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Platelet Rich Plasma Injection and Open Surgical Release
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to 29 Sep 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient who:
- Has experienced more than 6 months of symptoms from tennis elbow (pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist).
- Patients must also have failed conservative treatment (a course of physiotherapy and activity modification)
- Baseline elbow pain >3/10 on VAS during resisted elbow extension.
Who cannot join
- Presence of a full tendon tear on pre-intervention ultrasound
- Unfit for surgical intervention
- Have undergone previous elbow surgery,
- Have previously undergone PRP injection therapy
- Systemic autoimmune rheumatological disease
- Receiving immunosuppressive treatments
- Received local steroid injection within 3 months of randomization
- Unable to comply with follow-up.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Deveon and Exeter Hospital
Exeter, Devon, EX2 5DW
About this study
Official title: Platelet Rich Plasma vs Open Surgery in the Treatment of Chronic Lateral Epicondylar Tendinopathy (Tennis Elbow) A Pilot Randomized Control Trial
Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with repetitive use of the forearm extensor muscles. Though often self-limiting in nature there are a proportion of patients who fail to respond to conservative treatments such as rest, activity modification, physiotherapy and the use of a brace. Though previously a common treatment modality steroid injections have been shown to be detrimental in the longer term. Present practice is to offer those patients who do not respond to conservative treatment surgical debridement. Though often effective this is an invasive procedure. Platelet rich plasma injections may offer a viable alternative in chronic cases however there is no systematic evidence of its efficacy.
Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be randomly assigned to receive either open surgical debridement or platelet rich plasma injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6 and 12 months. The outcome of each treatment will be assessed using validated outcome scoring measures specifically designed for upper limb pathology. The results of this pilot study will be used to construct a larger randomised control trial.
Read the detailed description
Research Question
There is no difference in patient reported outcome measures between open surgical release and platelet rich plasma injection in the treatment of chronic lateral epicondylar tendinopathy (Tennis Elbow).
Aims
- To estimate the distribution of patient-reported outcome measures (PROMS) at 6 weeks, 3 months, 6 months and 1 year
- To record any adverse events associated with either treatment
- To test the feasibility of the study design in preparation for a larger randomised trial
- To collect data that will allow a power calculation for a larger randomised trial
- To use the data for a larger grant application
Objectives
- To randomise patients who have failed conservative management of tennis elbow to one of two treatment methods: Platelet Rich Plasma or Open Surgical Release
- To collect treatment outcome data in the form of a visual analogue scale, Oxford Elbow Score and DASH (Disability of Arm, Shoulder and Hand) score
- To use the current best guidance and administer leucocyte-rich PRP (L-PRP) under ultrasound guidance
- To use the data gained from a pilot study to assess the viability of a larger randomised control trial
Research design This pilot study will be conducted as a randomised controlled pilot trial at the Royal Devon and Exeter Hospital, UK.
Patient Selection Patients will be selected from those who attend the outpatient elbow clinic at the Royal Devon and Exeter Hospital. All patients will be reviewed by a Consultant Orthopaedic Surgeon specialised in Elbow surgery. The inclusion criteria will be any patient who has experienced more than 6 months of symptoms from tennis elbow, that include pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist. Patients must also have failed conservative treatment (a course of physiotherapy and activity modification) and have a baseline elbow pain >3/10 on VAS during resisted elbow extension.
Patients will be excluded: in the presence of a full tendon tear on pre-intervention ultrasound, are unfit for surgical intervention, have undergone previous elbow surgery, have previously undergone PRP injection therapy, systemic autoimmune rheumatological disease, receiving immunosuppressive treatments, received local steroid injection within 3 months of randomization or are unable to comply with follow-up.
Intervention The 2 arms of the trial will include PRP therapy or Open surgical debridement
- Platelet Rich Plasma injection
- Open Surgical Release (presently standard treatment regimen)
Both groups of patients will be given an identical physiotherapy programme and followed-up at identical timeframes to record the outcomes of the interventions.
Sample size The present proposal is intended to be a pilot study. As such the intention will be to randomise 6 patients to each arm of the trial, 12 patients in total. It has been estimated that 1 suitable patient is likely to be seen in the outpatient clinic each week. Owing for attrition and patient suitability it is hoped that a 6 month enrolment period will yield 12 patients.
Randomisation The participating patients will be randomised in a 1:1 allocation to open surgery or PRP injections. The randomisation will be administered by a central independent randomisation service, provided by a medical secretary using a computer-generated randomisation sequence and sealed in sequentially numbered envelopes, who is completely independent of the trial.
Outcome scoring Primary outcome measures will be in the form of Patient Reported Outcome Measures (PROMS) and Range of Motion (ROM) Primary Outcome: Change in Patient Rated Tennis Elbow Evaluation (PRTEE) between pre-intervention and at 3 months post-intervention - patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow
All secondary outcome measures to be completed pre-operatively and at 6 weeks, 3 months, 6 months and 12 months.
● PROMS Visual Analogue Scale (VAS) - Using a linear scale of 10cms length. Assessed through change in score over time.
Disabilities of the Arm, Shoulder and Hand (quickDASH) - patient compiled questionnaire based on subjective assessment of symptoms and abilities to perform activities of daily living over the last week.
Oxford Elbow Score (OES) - patient compiled questionnaire based on specific elbow symptoms related activities of daily living over the past 4 weeks.
Adverse events - peri-procedural, 6 weeks, 3 months, 6 months and 12 months
- Conditions
- Tennis Elbow
- Being tested
- Platelet Rich Plasma Injection, Open Surgical Release
- 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 InjectionProcedure or surgery
See Arms
Open Surgical ReleaseProcedure or surgery
See arms
| Study group | Role | What they receive |
|---|---|---|
| Platelet Rich Plasma injection | Experimental | In the outpatient setting a sample of venous whole blood will be taken from the patient (40mls), from the antecubital fossa using standard phlebotomy techniques. The Angel™ system will be in the available also in the outpatient clinic and will be used to separate the blood to yield a PRP sample (approximately 15 minutes preparation time). The PRP sample is then injected into the common extensor origin.
2 injections will be used per patient over 2 weeks. Receives: Procedure: Platelet Rich Plasma Injection |
| Open Surgical Release | Active comparator | Standardised surgical technique based on the Nirschl technique will be used. The patient will then have a small scar centred over the lateral epicondyle and the plane opened between ECRL (Extensor Carpi Radialis Longus) and EDC (Extensor Digitorum Communis) to expose the damaged ECRB (Extensor Carpi Radialis Brevis) tendon. The amount of abnormal tendon will be documented and excised. EDC will also be inspected and any abnormal tissue documented then excised. The footprint of the excised ECRB +/- EDC is cleared of soft tissue and the bone scored with an osteotome to promote bleeding. The interval is closed with suture material and the skin wound closed. Receives: Procedure: Open Surgical Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow
Measured: To be completed pre-intervention and at 3 months post-intervention
Secondary outcomes (4)
Change in Visual Analogue Scale (VAS)
- Using a linear scale of 10cms length. Assessed through change in score over time.
Measured: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Change in Disabilities of the Arm, Shoulder and Hand (quickDASH)
- patient compiled questionnaire based on subjective assessment of symptoms and abilities to perform activities of daily living over the last week.
Measured: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Change in Oxford Elbow Score (OES)
- patient compiled questionnaire based on specific elbow symptoms related activities of daily living over the past 4 weeks.
Measured: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Adverse events
Safety assessment
Measured: peri-procedural, 6 weeks, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C Gardener, Study chair, Research Development Directorate - Royal Devon and Exeter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755727
- Sponsor's protocol ID
- 1510155
- Status last verified
- May 2018
- First submitted
- 11 Apr 2016
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma vs Open Surgery in the Treatment of Chronic Lateral Epicondylar Tendinopathy (Tennis Elbow) A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02755727
- Acronym / sponsor ID
- 1510155
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 29 Apr 2016 (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.
Chronic Lateral Epicondylar Tendinopathy is a debilitating condition that is associated with repetitive use of the forearm extensor muscles. Though often self-limiting in nature there are a proportion of patients who fail to respond to conservative treatments such as rest, activity modification, physiotherapy and the use of a brace. Though previously a common treatment modality steroid injections have been shown to be detrimental in the longer term. Present practice is to offer those patients who do not respond to conservative treatment surgical debridement. Though often effective this is an invasive procedure. Platelet rich plasma injections may offer a viable alternative in chronic cases however there is no systematic evidence of its efficacy.
Methods 12 patients, diagnosed with chronic lateral epicondylar tendinopathy, will be randomly assigned to receive either open surgical debridement or platelet rich plasma injections. Following treatment, they will be followed up at intervals of 6 weeks and 3, 6 and 12 months. The outcome of each treatment will be assessed using validated outcome scoring measures specifically designed for upper limb pathology. The results of this pilot study will be used to construct a larger randomised control trial.
Detailed description
Research Question
There is no difference in patient reported outcome measures between open surgical release and platelet rich plasma injection in the treatment of chronic lateral epicondylar tendinopathy (Tennis Elbow).
Aims
- To estimate the distribution of patient-reported outcome measures (PROMS) at 6 weeks, 3 months, 6 months and 1 year
- To record any adverse events associated with either treatment
- To test the feasibility of the study design in preparation for a larger randomised trial
- To collect data that will allow a power calculation for a larger randomised trial
- To use the data for a larger grant application
Objectives
- To randomise patients who have failed conservative management of tennis elbow to one of two treatment methods: Platelet Rich Plasma or Open Surgical Release
- To collect treatment outcome data in the form of a visual analogue scale, Oxford Elbow Score and DASH (Disability of Arm, Shoulder and Hand) score
- To use the current best guidance and administer leucocyte-rich PRP (L-PRP) under ultrasound guidance
- To use the data gained from a pilot study to assess the viability of a larger randomised control trial
Research design This pilot study will be conducted as a randomised controlled pilot trial at the Royal Devon and Exeter Hospital, UK.
Patient Selection Patients will be selected from those who attend the outpatient elbow clinic at the Royal Devon and Exeter Hospital. All patients will be reviewed by a Consultant Orthopaedic Surgeon specialised in Elbow surgery. The inclusion criteria will be any patient who has experienced more than 6 months of symptoms from tennis elbow, that include pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist. Patients must also have failed conservative treatment (a course of physiotherapy and activity modification) and have a baseline elbow pain >3/10 on VAS during resisted elbow extension.
Patients will be excluded: in the presence of a full tendon tear on pre-intervention ultrasound, are unfit for surgical intervention, have undergone previous elbow surgery, have previously undergone PRP injection therapy, systemic autoimmune rheumatological disease, receiving immunosuppressive treatments, received local steroid injection within 3 months of randomization or are unable to comply with follow-up.
Intervention The 2 arms of the trial will include PRP therapy or Open surgical debridement
- Platelet Rich Plasma injection
- Open Surgical Release (presently standard treatment regimen)
Both groups of patients will be given an identical physiotherapy programme and followed-up at identical timeframes to record the outcomes of the interventions.
Sample size The present proposal is intended to be a pilot study. As such the intention will be to randomise 6 patients to each arm of the trial, 12 patients in total. It has been estimated that 1 suitable patient is likely to be seen in the outpatient clinic each week. Owing for attrition and patient suitability it is hoped that a 6 month enrolment period will yield 12 patients.
Randomisation The participating patients will be randomised in a 1:1 allocation to open surgery or PRP injections. The randomisation will be administered by a central independent randomisation service, provided by a medical secretary using a computer-generated randomisation sequence and sealed in sequentially numbered envelopes, who is completely independent of the trial.
Outcome scoring Primary outcome measures will be in the form of Patient Reported Outcome Measures (PROMS) and Range of Motion (ROM) Primary Outcome: Change in Patient Rated Tennis Elbow Evaluation (PRTEE) between pre-intervention and at 3 months post-intervention - patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow
All secondary outcome measures to be completed pre-operatively and at 6 weeks, 3 months, 6 months and 12 months.
● PROMS Visual Analogue Scale (VAS) - Using a linear scale of 10cms length. Assessed through change in score over time.
Disabilities of the Arm, Shoulder and Hand (quickDASH) - patient compiled questionnaire based on subjective assessment of symptoms and abilities to perform activities of daily living over the last week.
Oxford Elbow Score (OES) - patient compiled questionnaire based on specific elbow symptoms related activities of daily living over the past 4 weeks.
Adverse events - peri-procedural, 6 weeks, 3 months, 6 months and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet Rich Plasma injection | Experimental | Procedure: Platelet Rich Plasma InjectionIn the outpatient setting a sample of venous whole blood will be taken from the patient (40mls), from the antecubital fossa using standard phlebotomy techniques. The Angel™ system will be in the available also in the outpatient clinic and will be used to separate the blood to yield a PRP sample (approximately 15 minutes preparation time). The PRP sample is then injected into the common extensor origin. 2 injections will be used per patient over 2 weeks. |
| Open Surgical Release | Active comparator | Procedure: Open Surgical ReleaseStandardised surgical technique based on the Nirschl technique will be used. The patient will then have a small scar centred over the lateral epicondyle and the plane opened between ECRL (Extensor Carpi Radialis Longus) and EDC (Extensor Digitorum Communis) to expose the damaged ECRB (Extensor Carpi Radialis Brevis) tendon. The amount of abnormal tendon will be documented and excised. EDC will also be inspected and any abnormal tissue documented then excised. The footprint of the excised ECRB +/- EDC is cleared of soft tissue and the bone scored with an osteotome to promote bleeding. The interval is closed with suture material and the skin wound closed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has experienced more than 6 months of symptoms from tennis elbow (pain on the lateral elbow that radiates down the forearm, point tenderness over the origin of the extensor muscles or at its close proximity (within 2.5cm) and pain on resisted extension of the Wrist).
- Patients must also have failed conservative treatment (a course of physiotherapy and activity modification)
- Baseline elbow pain >3/10 on VAS during resisted elbow extension.
Key exclusion criteria (8 listed)
- Presence of a full tendon tear on pre-intervention ultrasound
- Unfit for surgical intervention
- Have undergone previous elbow surgery,
- Have previously undergone PRP injection therapy
- Systemic autoimmune rheumatological disease
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 InjectionSee Arms | Procedure or surgery | Platelet Rich Plasma injection |
| Open Surgical ReleaseSee arms | Procedure or surgery | Open Surgical Release |
Primary outcome
Change in Patient Rated Tennis Elbow Evaluation (PRTEE)
Time frame: To be completed pre-intervention and at 3 months post-intervention
patient compiled questionnaire based on specific elbow symptoms of Tennis Elbow
4 secondary outcomes
Change in Visual Analogue Scale (VAS)
Time frame: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Change in Disabilities of the Arm, Shoulder and Hand (quickDASH)
Time frame: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Change in Oxford Elbow Score (OES)
Time frame: To be completed pre-operatively and at 6 weeks, 3 months, 6 month and 12 months post-intervention
Adverse events
Time frame: peri-procedural, 6 weeks, 3 months, 6 months and 12 months
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 11 May 2018.
- Individual participant dataSharing planned: No
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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.
C Gardener study chair
Research Development Directorate - Royal Devon and Exeter Hospital
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 Injection and Open Surgical Release in people with Tennis Elbow, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 8 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 11 May 2018. 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 United Kingdom. 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. 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?
Change in Patient Rated Tennis Elbow Evaluation (PRTEE) (time frame: To be completed pre-intervention and at 3 months post-intervention). 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 11 May 2018.