Lateral Epicondylitis Clinical Trial
— CITTEOfficial 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.
NCT number | NCT03984955 |
Other study ID # | R&D 1026 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 18, 2018 |
Est. completion date | April 18, 2024 |
Verified date | July 2022 |
Source | Wrightington, Wigan and Leigh NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 123 |
Est. completion date | April 18, 2024 |
Est. primary completion date | April 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: - 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. - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Wrightington Wigan and Leigh NHS Foundation Trust | Wigan | Lancashire |
Lead Sponsor | Collaborator |
---|---|
Wrightington, Wigan and Leigh NHS Foundation Trust | TRB Chemedica |
United Kingdom,
Assendelft W, Green S, Buchbinder R, Struijs P, Smidt N. Tennis elbow. BMJ. 2003 Aug 9;327(7410):329. Review. — View Citation
Beard JM, Safranek SM, Spogen D. Clinical inquiries. What treatment works best for tennis elbow? J Fam Pract. 2009 Mar;58(3):159-61. — View Citation
Funk L. (2005) Hyaluronan vs Corticosteroids for Subacromial Impingement of the Shoulder. Osteoarthritis & Cartilage. 13(Suppl A)
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. — View Citation
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. Review. Update in: Cochrane Database Syst Rev. 2013;5:CD003686. — View Citation
Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15;76(6):843-8. Review. — View Citation
Lo MY, Safran MR. Surgical treatment of lateral epicondylitis: a systematic review. Clin Orthop Relat Res. 2007 Oct;463:98-106. Review. — View Citation
Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30. — View Citation
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. — View Citation
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. — View Citation
Smidt N, van der Windt DA, Assendelft WJ, Devillé 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | The QuickDASH scores will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. | |
Secondary | 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. | The VAS will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. | |
Secondary | 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. | The OES will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. | |
Secondary | 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. | The EQ-5D will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. | |
Secondary | 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. | The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. | |
Secondary | Change in HADS score at 12 months compared to baseline | See above | The HAD score will be recorded at baseline, and will be repeated at 3 months and 12 months post-injection. |
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