Tennis ElbowCITTENCT03984955
Comparing Injection Treatments for Tennis Elbow
A study testing Sodium hyaluronate with mannitol (Ostenil Tendon) and Platelet-Rich Plasma Injection in people with Tennis Elbow and Lateral Epicondylitis, run by Wrightington, Wigan and Leigh NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Tennis elbow is one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tennis Elbow, Lateral Epicondylitis, Elbows Tendonitis
- What is being tested?
- Sodium hyaluronate with mannitol (Ostenil Tendon) and Platelet-Rich Plasma Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2018to 6 Feb 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invitations to participate in the study will be extended to male and female patients, 18 years and above, referred to the Orthopaedic Departments who receive a diagnosis of Lateral Epicondyle Tendinosis (with or without degenerative changes) with symptoms present for > 3 months, whose symptoms and clinical evaluation warrant the prescription of a peri-tendinous injection to relieve symptoms and who are competent to give informed consent.
Who cannot join
- Absence of tenderness at the lateral epicondyle.
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Wrightington Wigan and Leigh NHS Foundation Trust
Wigan, Lancashire, WN6 9EP
Adam C Watts, +441257256365, Adam.C.Watts@wwl.nhs.uk
Lindsay Cunningham, +44 1257488212, lindsay.j.cunningham@wwl.nhs.uk
About this study
Official title: A Prospective, Double Blind, Single Centre, RCT, Comparing the Effectiveness of Physiotherapy in Addition to One of 3 Types of Image Guided Injection of the Common Extensor Tendon, on Pain and Function in Patients With Tennis Elbow.
Tennis elbow is one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach.
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.
Read more
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.
Read the detailed description
The design of the current study is a prospective, randomised, controlled, double blinded, single centre trial.
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
- Tennis Elbow, Lateral Epicondylitis, Elbows Tendonitis
- Being tested
- Sodium hyaluronate with mannitol (Ostenil Tendon), Platelet-Rich Plasma Injection, Subcutaneous sham injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate with mannitol (Ostenil Tendon)Device
Also called 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 InjectionDevice
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 injectionOther
Sham injection will penetrate the skin, but no therapeutic substance will be injected
| Study group | Role | What they receive |
|---|---|---|
| Group A PRP injection | Active comparator | 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. Receives: Device: Platelet-Rich Plasma Injection |
| Group B Ostenil Tendon | Active comparator | 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. Receives: Device: Sodium hyaluronate with mannitol (Ostenil Tendon) |
| Group C control group | Sham comparator | 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. Receives: Other: Subcutaneous sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Objective functional assessment as evidenced by the change in Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores from pre-treatment to 12 months post treatment.
The QuickDASH consists of 11 items which were extracted from the original 30-item DASH scale. To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the original DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).
Measured: The QuickDASH scores will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Secondary outcomes (5)
The change from baseline in objective pain scores as evidenced by the Visual Analogue Pain Scale (VAS) at 12 months post-treatment.
The Visual Analogue Pain scale is a horizontal line, 100 mm in length, anchored by descriptors at each end, namely 'No pain at all' on the left side and 'Worst imaginable pain' on the right side. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: The VAS will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
The change in objective functional assessment as evidenced by the Oxford Elbow Score (OES)
The Oxford Elbow Score (OES) is a short 12-item patient-reported outcome measure originally designed and developed for assessing outcomes of elbow surgery.The OES has 12 items (questions) with 5 response options each. Each item response is scored as 0 to 4, with 0 representing greater severity. Underlying the 12 items are 3 domains (subscales): elbow pain, elbow function and social-psychological effects. Scores for each domain are calculated as the sum of each individual item score within that domain. This gives a score range of 0-16 for each domain and 0-48 overall, with 0 indicating the worst elbow score and 48 as a 'normal' elbow score.
Measured: The OES will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Change in general health-related quality of life as evidenced by change in the EQ-5D general health questionnaire.
The EQ-5D is a standardised instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by marking the box against the most appropriate statement in each of the 5 dimensions.The EQ VAS then records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
Measured: The EQ-5D will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Relationship of pre-injection Hospital Anxiety and Depression Scale (HADS) score to the outcome
The Hospital Anxiety and Depression Scale (HADS) is a valid and reliable self-rating scale that measures anxiety and depression in both hospital and community settings. The HADS comprises 14 questions, seven relating to anxiety and seven relating to depression. Each item is scored from 0-3, with higher scores indicating higher symptoms frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. Prior to completing the scale patients are asked to ensure the answers they given reflect how they have been feeling during the past week.
Measured: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Change in HADS score at 12 months compared to baseline
See above
Measured: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start18 Apr 2018
- Primary completion6 Feb 2026 (estimated)
- Study completion6 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- 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
- Model description
- Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- TRB Chemedica
- Responsible party
- Sponsor
- Investigators
- Adam Watts, Principal investigator, Wrightington, Wigan and Leigh NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984955
- Sponsor's protocol ID
- R&D 1026
- Acronym
- CITTE
- Status last verified
- Aug 2024
- First submitted
- 21 Feb 2019
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25685118Smidt 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.
PubMed 11879861Lo 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.
PubMed 17632419Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
PubMed 17910298Green 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.
PubMed 12076503Beard 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.
PubMed 19284945Assendelft 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.
PubMed 12907489Saito 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.
PubMed 20235211Funk 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.
PubMed 20205851Mishra 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.
PubMed 16735582Karjalainen 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Single Centre, RCT, Comparing the Effectiveness of Physiotherapy in Addition to One of 3 Types of Image Guided Injection of the Common Extensor Tendon, on Pain and Function in Patients With Tennis Elbow.
- ClinicalTrials.gov ID
- NCT03984955
- Acronym / sponsor ID
- CITTE / R&D 1026
- Conditions
- Tennis Elbow, Lateral Epicondylitis, Elbows Tendonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Wrightington, Wigan and Leigh NHS Foundation TrustUniversity, hospital or other
- Collaborators
- TRB Chemedica
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 6 Feb 2026 (estimated)
- Study completion
- 6 Feb 2026 (estimated)
- First posted
- 13 Jun 2019 (actual)
- 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 one of the most common musculoskeletal problems affecting the arm and is thought to be mainly due to overuse of the muscles that extend the wrist. The pain arises from the lateral epicondyle of the humerus, where the tendons of the wrist extensor muscles attach.
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.
Detailed description
The design of the current study is a prospective, randomised, controlled, double blinded, single centre trial.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
| Arm | Type | Receives |
|---|---|---|
| Group A PRP injection | Active comparator | Device: Platelet-Rich Plasma InjectionPlatelet-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. |
| Group B Ostenil Tendon | Active comparator | Device: Sodium hyaluronate with mannitol (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. |
| Group C control group | Sham comparator | Other: Subcutaneous sham injectionSubcutaneous 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invitations to participate in the study will be extended to male and female patients, 18 years and above, referred to the Orthopaedic Departments who receive a diagnosis of Lateral Epicondyle Tendinosis (with or without degenerative changes) with symptoms present for > 3 months, whose symptoms and clinical evaluation warrant the prescription of a peri-tendinous injection to relieve symptoms and who are competent to give informed consent.
Key exclusion criteria (11 listed)
- Absence of tenderness at the lateral epicondyle.
- 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
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 |
|---|---|---|
| Sodium hyaluronate with mannitol (Ostenil Tendon)Also: Ostenil Tendon1ml isotonic solution contains 20.0mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections. | Device | Group B Ostenil Tendon |
| Platelet-Rich Plasma InjectionPlatelet-rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets which is then injected at the site of tendon injury. | Device | Group A PRP injection |
| Subcutaneous sham injectionSham injection will penetrate the skin, but no therapeutic substance will be injected | Other | Group C control group |
Primary outcome
The change in Objective functional assessment as evidenced by the change in Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores from pre-treatment to 12 months post treatment.
Time frame: The QuickDASH scores will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
The QuickDASH consists of 11 items which were extracted from the original 30-item DASH scale. To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the original DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).
5 secondary outcomes
The change from baseline in objective pain scores as evidenced by the Visual Analogue Pain Scale (VAS) at 12 months post-treatment.
Time frame: The VAS will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
The change in objective functional assessment as evidenced by the Oxford Elbow Score (OES)
Time frame: The OES will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Change in general health-related quality of life as evidenced by change in the EQ-5D general health questionnaire.
Time frame: The EQ-5D will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Relationship of pre-injection Hospital Anxiety and Depression Scale (HADS) score to the outcome
Time frame: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Change in HADS score at 12 months compared to baseline
Time frame: The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Background: PubMed 25685118Gliedt 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.
- Background: PubMed 11879861Smidt 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.
- Background: PubMed 17632419Lo 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.
- Background: PubMed 17910298Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8.
- Background: PubMed 12076503Green 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.
- Background: PubMed 19284945Beard 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.
- Background: PubMed 12907489Assendelft 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.
- Background: PubMed 20235211Saito 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.
- BackgroundFunk L. (2005) Hyaluronan vs Corticosteroids for Subacromial Impingement of the Shoulder. Osteoarthritis & Cartilage. 13(Suppl A)
- Background: PubMed 20205851Petrella 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.
- Background: PubMed 16735582Mishra 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.
- 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.
- 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.
Wrightington Wigan and Leigh NHS Foundation Trust
Wigan, United Kingdom
Adam Watts principal investigator
Wrightington, Wigan and Leigh NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hyaluronate with mannitol (Ostenil Tendon) and Platelet-Rich Plasma Injection in people with Tennis Elbow and Lateral Epicondylitis, run by Wrightington, Wigan and Leigh 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Objective functional assessment as evidenced by the change in Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores from pre-treatment to 12 months post treatment. (time frame: The QuickDASH scores will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection.). 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 NCT03984955, which also lists 12 linked publications.
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 6 Aug 2024.