Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
123 participants
INTERVENTIONAL
2018-04-18
2026-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
There are many treatment options available for tennis elbow including oral medication, physiotherapy and injection therapy. Surgical options are reserved for those who fail to respond to more conservative treatments. Physiotherapy is a widely used, non-invasive treatment option for the management of tennis elbow. Research has shown that in the longer term, physiotherapy is superior to corticosteroid injection in the treatment of tennis elbow and a meta-analysis of published research concluded that Platelet Rich Plasma injection and Hyaluronic Acid injection are superior to corticosteroid for long term pain relief in tennis elbow.
At present there is not enough evidence to indicate what the 'Gold Standard' treatment for tennis elbow is, and more research is therefore needed to help guide decision-making. The aim of this study is therefore to examine the effects of injection therapy in addition to physiotherapy treatment, in comparison to physiotherapy and a control injection on pain and function in patients with tennis elbow.
All participants in this study will undergo a structured, specifically designed, class-based physiotherapy intervention, in addition to being randomly allocated to receive one of the following three types of injection: (a) a control injection whereby a needle is inserted into the skin but no therapeutic substance is injection, (b) a single therapeutic injection of platelet-rich plasm or (c) a single therapeutic injection of hyaluronic acid. Baseline data will be collected at the time of recruitment and participants will be followed up at 3 months and 12 months post treatment. Outcomes will be assessed using various patient-reported outcome measures in addition to clinical examination. The primary outcome for this study is the improvement in the quick DASH score at 12 months post-treatment compared to baseline.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Intra-articular and Intra-tendinous Injections for Treatment of Lateral Epicondylitis
NCT02986646
Trial of Physiotherapy and Corticosteroid Injections in Lateral Epicondylalgia
NCT00110318
Comparison of Conservative Methods for the Treatment of Lateral Epicondylitis: A Randomized, Prospective Study
NCT01897259
Efficacy Study of Prolotherapy vs Corticosteroid for Tennis Elbow
NCT00160303
Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)
NCT01668953
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
On the day of their initial appointment in the outpatient department, patients diagnosed with tennis elbow by their consultant who meet all of the necessary inclusion and exclusion criteria will be introduced to the study by the consultant. They will also be provided with a copy of the participant information sheet.
When the potential participant then attends their pre-operative assessment appointment, they will be invited to discuss the study further with a member of the host Trust's research team. If they then wish to proceed, they will be invited to read and sign a copy of the study consent form. Consenting patients will then be asked to complete a questionnaire designed to record all relevant demographic data including: Age, gender, affected side, dominant side, weight, height (so that BMI may be calculated), duration of symptoms, current use of pain-relieving medications, occupation, leisure activities and ethnicity. They will also be asked to complete a visual analogue pain scale, and the following 4 validated patient reported outcome measures.
Following completion of the patient reported outcome questionnaires, participants will then be randomised to one of the following three treatment groups: Group(A)will receive a standardised, class-based physiotherapy program in addition to a single therapeutic injection of Platelet-Rich Plasma; Group (B) will undergo an identical physiotherapy program to group A, but with a single therapeutic injection of sodium hyaluronate with mannitol; or group (C) who will undergo an identical physiotherapy program to both groups (A) and (B), however they will receive a sham injection, which will penetrate the skin, but no therapeutic substance will be injected.
The randomisation sequence will be generated using freely available online randomisation facilities prior to the start of the study. Participants will be randomised to either Group A, Group B or Group C in a 1:1:1 ratio (see above for group descriptions). The allocation sequence will be concealed in sealed opaque envelopes which will be prepared prior to the start of the study and will be opened after informed consent has been gained and baseline data has been collected.
Consenting participants will all attend Wrightington Hospital for their allocated injection to be administered under ultrasound guidance to ensure accurate needle placement. All participants will have 30mls of whole blood drawn under aseptic conditions in order to aid blinding of participants to their treatment allocation.
For those allocated to receive a PRP injection (Group A), the whole blood will be placed in a cell separator and centrifuged at 32000 rpm for 15 minutes. Whilst the blood is being centrifuged, 2ml of 2% plain lidocaine will be injected into the subcutaneus layer at the site where the PRP is to be injected. 1ml of the PRP produced will then be drawn into a syringe which will be wrapped in silver foil so as to conceal the contents from the participants. The PRP will then be injected into the lateral epicondyle via a blue (20 gauge) hypodermic needle using a peppering technique under ultrasound control.
For Groups (B) and (C), the withdrawn blood will be discarded into a suitable clinical waste container out of sight of the participant in an adjoining room. The centrifuge, also in the adjoining room, will be set to run at 32000rpm for 15 minutes in order to aid in participant blinding. For those in group (B), whilst the centrifuge is running, 2ml of 2% plain lidocaine will be injected into the subcutaneous layer at the site of injection. A pre-prepared 'Ostenil Tendon' syringe will be wrapped in silver foil (again to help conceal the nature of the contents from the participants) and 2ml will be injected into the peri-tendinous area via a blue (20 gauge) hypodermic needle under ultrasound control.
For those in group (C) whilst the centrifuge is running, 2ml of 2% plain lidocaine will be injected into the subcutaneous layer at the site of injection. An empty syringe wrapped in silver foil with a blue (20 gauge) will then be used to perform a sham injection into the subcutaneous tissue only, by passing the needles into the tissue with no injectate.
In order to further aid blinding of participants, during the procedure they will be distracted by asking them to confirm their personal details.
In order to gain a measure of how the participant's pain changes in the days and weeks following surgery, they will be given a pain diary on the day of their treatment to complete on days 1,2,3,7,14, and at 6 and 12 weeks.
Prior to discharge from the hospital participants will be taught basic home exercises by a physiotherapist who is unaware of the participant's group allocation. they will then begin a specifically designed, formal, class-based physiotherapy program 5-15 days post-injection. Exercises taught on the day of treatment will include eccentric loading exercises of the wrist extensors and they will be asked to commence these exercises the day after the injection and to complete 3 sets of 15 repetitions 3 times per day. They will also be taught simple stretches of the wrist extensors to complete after each set of eccentric strengthening exercises.
The formal physiotherapy program will include fortnightly physiotherapy classes taught by a blinded physiotherapist. After being taught the exercises on a 1:1 basis in order to ensure correct technique, the participants will be supervised during a circuit style exercise program. The circuit will include exercises to load the common extensors, strengthening of the rotator cuff muscles, strengthening of the scapular stabilising muscles and upper limb strengthening using the full kinetic chain. Participants will also be taught a home exercise program which will reflect the content of the class circuit.
At 3 months and 12 months post-injection participants will be assessed by a clinician who again is unaware of the participant's grouping. At each follow-up, the participants will be asked to complete the patient reported outcome questionnaires. They will also be asked regarding their use of rescue medication (i.e. how much analgesic medication they require to manage their pain) and this will be recorded by the clinician.
If any participant is unable to attend the hospital for follow-up at either the 3 or 12 month time-point, they will be contacted by telephone to gather the outcome information. All participants will be discharged from the care of the treating consultant at 12 weeks unless enduring or subsequently manifesting symptoms are present and the final 12 month visit will therefore be solely for the purposes of research.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The class-based physiotherapy sessions will be taught be a physiotherapist who is blind to the treatment allocation of the study participants attending the class.
The outcome assessments will be recorded by a member of the research team blind to the participant's treatment allocation.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A PRP injection
Platelet-Rich Plasma injection Single therapeutic injection of Platelet-Rich Plasma performed under ultrasound guidance.
This group will also undergo a class-based physiotherapy intervention. This outcomes for this group will be compared to those receiving Sodium hyaluronate with mannitol (Ostenil Tendon) and those receiving the sham injection.
Platelet-Rich Plasma Injection
Platelet-rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets which is then injected at the site of tendon injury.
Group B Ostenil Tendon
Sodium hyaluronate with mannitol (Ostenil Tendon) Single therapeutic injection of sodium hyaluronate with mannitol (marketed under the device name Ostenil Tendon) under ultrasound guidance. This group will also undergo a class-based physiotherapy intervention.
Sodium hyaluronate with mannitol (Ostenil Tendon)
1ml isotonic solution contains 20.0mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
Group C control group
Subcutaneous sham injection. This group will also undergo a class-based physiotherapy intervention. The outcomes for this group will be compared to those receiving Sodium hyaluronate with mannitol (Ostenil Tendon) and to those receiving PRP injection.
Subcutaneous sham injection
Sham injection will penetrate the skin, but no therapeutic substance will be injected
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sodium hyaluronate with mannitol (Ostenil Tendon)
1ml isotonic solution contains 20.0mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
Platelet-Rich Plasma Injection
Platelet-rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets which is then injected at the site of tendon injury.
Subcutaneous sham injection
Sham injection will penetrate the skin, but no therapeutic substance will be injected
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Congenital or traumatic bio-mechanical deformities of Elbow complex.
* Previous Corticosteroidal, Local Anaesthetic, PRP or Hyaluronic Acid injections to target elbow within the last three months.
* Known hypersensitivity to PRP, Hyaluronic acid or any excipients associated with any of the prescribed injections.
* Known contraindication to any treatments constituting normal/appropriate therapy in the view of the Consulting clinician including local infection
* Ipsilateral arm pathology severe enough to cause confusion of localised pain perception.
* Pregnant or lactating women
* Pain score less than 4/10
* Patients commenced on medication for the treatment of anxiety or depression within the last 6 weeks
* Previous involved in research in last 12 months
* Any progressive, degenerative neuromuscular disorder
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TRB Chemedica
INDUSTRY
Wrightington, Wigan and Leigh NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adam Watts
Role: PRINCIPAL_INVESTIGATOR
Wrightington, Wigan and Leigh NHS Foundation Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wrightington Wigan and Leigh NHS Foundation Trust
Wigan, Lancashire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gliedt JA, Daniels CJ. Chiropractic treatment of lateral epicondylitis: a case report utilizing active release techniques. J Chiropr Med. 2014 Jun;13(2):104-9. doi: 10.1016/j.jcm.2014.06.009.
Smidt N, van der Windt DA, Assendelft WJ, Deville WL, Korthals-de Bos IB, Bouter LM. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):657-62. doi: 10.1016/S0140-6736(02)07811-X.
Lo MY, Safran MR. Surgical treatment of lateral epicondylitis: a systematic review. Clin Orthop Relat Res. 2007 Oct;463:98-106. doi: 10.1097/BLO.0b013e3181483dc4.
Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt N, Assendelft W. Non-steroidal anti-inflammatory drugs (NSAIDs) for treating lateral elbow pain in adults. Cochrane Database Syst Rev. 2002;(2):CD003686. doi: 10.1002/14651858.CD003686.
Beard JM, Safranek SM, Spogen D. Clinical inquiries. What treatment works best for tennis elbow? J Fam Pract. 2009 Mar;58(3):159-61. No abstract available.
Assendelft W, Green S, Buchbinder R, Struijs P, Smidt N. Tennis elbow. BMJ. 2003 Aug 9;327(7410):329. doi: 10.1136/bmj.327.7410.329. No abstract available.
Saito S, Furuya T, Kotake S. Therapeutic effects of hyaluronate injections in patients with chronic painful shoulder: a meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul;62(7):1009-18. doi: 10.1002/acr.20174.
Funk L. (2005) Hyaluronan vs Corticosteroids for Subacromial Impingement of the Shoulder. Osteoarthritis & Cartilage. 13(Suppl A)
Petrella RJ, Cogliano A, Decaria J, Mohamed N, Lee R. Management of Tennis Elbow with sodium hyaluronate periarticular injections. Sports Med Arthrosc Rehabil Ther Technol. 2010 Feb 2;2:4. doi: 10.1186/1758-2555-2-4.
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. doi: 10.1177/0363546506288850. Epub 2006 May 30.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R&D 1026
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.