Elbow Tendinopathy Clinical Trial
Official title:
Evaluation of Clinical Efficacy and Comparison of Autologous Platelet Rich Plasma, Hyaluronic Acid, Corticosteroid and Saline Injections for Treating Lateral and Medial Humeral Epicondylopathy
Humeral epicondylopathies are common disorders which can significantly impair upper limb function. In case of failure of rehabilitation protocol there is no evidence based second line therapy. It is common practice to perform one of the injection procedures. The biological mechanisms of these procedures are unclear, and may even be contrary. These include, but are not limited to, injections of corticosteroids, autologous platelet rich plasma (PRP) and hyaluronic acid (HA). Despite the frequent use there is much controversy about their clinical effectiveness and more evidence based data are required. The aim of the study is to compare three different injection therapies for lateral epicondylopathy. In addition, correlation between selected bioactive compounds in PRP and its clinical effectiveness will be evaluated. The study is planned as a single-center, prospective, randomized, double-blinded, controlled trial on 120 patients aged 30-60 who suffer for lateral epicondylitis. After meeting the inclusion and exclusion criteria patients will receive an injection of leukocyte-rich autologous PRP (N1), corticosteroid (N2), HA (N3) in the area of the common extensors tendon attachment, respectively. Patients from control group (N4) will get an injection of saline in the same area. All groups will be instructed how to perform everyday stretching and strengthening exercises. Evaluation of clinical effectiveness of the treatment will be based on objective measurements such as range of motion, limb girth, grip strength, X-ray and ultrasound examination and subjective measurements such as pain (VAS), functional (PRTEE, DASH, SEV, MEPS) and quality of life questionnaires (SF-36) before and during follow-up period (1, 4, 12, 24, 52 weeks). PRP samples will undergo laboratory analysis of levels of bioactive compounds including platelets, white blood cells, erythrocytes and selected growth factors and inflammatory cytokines. After data collection, the clinical effectiveness of three different injection therapies will be evaluated and statistically analyzed. Subjective and objective outcomes, safety, costs-effectiveness of three different injection therapies compared to placebo and between each other will be assessed. In addition, correlation between levels of bioactive compounds in PRP and its efficacy will be checked.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: - pain on the lateral side of the elbow joint for at least three months, - confirmation of lateral epicondylitis in at least one provocative test, - no previous invasive treatment, - no improvement after rehabilitation Exclusion Criteria: - nervous system diseases related to the upper limb, - hematological diseases, - diabetes, - tumors of upper extremity, - gout, - advanced osteoarthritis, - previously performed operations around the elbow joint, - suspicion of the infectious process, - pregnant |
Country | Name | City | State |
---|---|---|---|
Poland | Sport Division, Wroclaw Medical University | Wroclaw | Woj. Dolnoslaskie |
Lead Sponsor | Collaborator |
---|---|
Wroclaw Medical University |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of adverse events | collecting information about any adverse events related with treatment | 0, 1, 4, 12, 24, 52 weeks | |
Other | Comparison of treatment cost-effectiveness | comparison of different methods total treatment costs from intervention to complete recovery | 52 weeks | |
Primary | Change in pain level assessed by Visual Analog Scale | the change of pain level in the region of lateral or medial humeral epicondyle after treatment represented on Visual Analog Scale (VAS) scoring from 0 (no-pain) to 10 (worst imaginable pain) | 0, 1, 4, 12, 24, 52 weeks | |
Primary | Change in functional outcome assessed by Patient-rated Tennis Elbow Evaluation | the change in the results of functional questionnaire - Patient-rated Tennis Elbow Evaluation (PRTEE), scale from 0 to 100, lower value means less disability | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in muscle strength assessed by hand held dynamometer | the forearm muscle strength and grip strength change after treatment measured by hand held dynamometer (higher load means better outcome) | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in ultrasound examination image | any changes in ultrasound examination images of lateral or medial humeral epicondyle region after treatment | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in results of quality of life questionnaire SF-36 | any changes in the results of The Quality of life questionnaire SF-36, scale 0-100, lower score means more disability | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in functional outcome assessed by Disabilities of the Arm, Shoulder, and Hand | the change in the results of functional questionnaire - Disabilities of the Arm, Shoulder, and Hand (DASH), scale from 0 to 100, higher scores reflects to more disability | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in functional outcome assessed by The Subjective Elbow Value | the change in the results of functional questionnaire - The Subjective Elbow Value (SEV), scale from 0 to 100%, subjective self rating of patients elbow, 100% means normal elbow | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in functional outcome assessed by Mayo Elbow Performance Score | the change in the results of functional questionnaire - Mayo Elbow Performance Score (MEPS), scale from 0 to 100, higher value indicates a better condition | 0, 4, 12, 24, 52 weeks | |
Secondary | Change in functional outcome assessed by The Oxford Elbow Score | the change in the results of functional questionnaire - The Oxford Elbow Score, scale from 0 to 100, higher value indicates a better condition | 0, 4, 12, 24, 52 weeks |
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