NCT03984955.

Study name	Comparing injection treatments for tennis elbow (CITTE)
Methods	Prospective controlled randomised double‐blind single‐centre trial
Participants	Inclusion criteria Invitation to participate in the study will be extended to male and female patients 18 years of age and older; referred to the Orthopaedic Departments Diagnosis of lateral epicondyle tendinosis (with or without degenerative changes) Symptoms present > 3 months Competent to give informed consent Exclusion criteria Absence of tenderness at the lateral epicondyle Congenital or traumatic biomechanical deformity of elbow complex Previous glucocorticoid, local anaesthetic, PRP, or hyaluronic acid injection to target elbow within the last 3 months Known hypersensitivity to PRP, hyaluronic acid, or any excipient associated with any of the prescribed injections Known contraindication to any treatment 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 Pain score < 4/10 Commenced medication for treatment of anxiety or depression within the last 6 weeks Previously involved in research in the last 12 months Any progressive, degenerative neuromuscular disorder
Interventions	Platelet‐rich plasma injection group Platelet‐rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets, which is injected at the site of tendon injury Sodium hyaluronate with mannitol (ostenil tendon) group 1 mL of isotonic solution contains 20.0 mg of sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol, and water for injection Subcutaneous sham injection group Sham injection will penetrate the skin, but no therapeutic substance will be injected
Outcomes	Primary outcome measure Change in objective functional assessment as evidenced by the change in Quick Disabilities of the Arm, Shoulder and Hand (DASH) scores from pretreatment to 12 months post treatment. Scale from 0 (no disability) to 100 (most severe disability) Secondary outcome measures Change from baseline in objective pain scores as evidenced by the visual analogue pain scale (VAS) (at 3 months and 12 months post injection) Visual analogue pain scale (VAS) 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. Patients mark on the line the point that they feel represents their perception of current pain. VAS score is determined by measuring in millimetres from the left‐hand end of the line to the point that the patient marks Change in objective functional assessment as evidenced by the Oxford Elbow Score (OES) (at 3 months and 12 months). 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 to 16 for each domain and 0 to 48 overall, with 0 indicating the worst elbow score and 48 a 'normal' elbow score Change in general health‐related quality of life as evidenced by change in the EQ‐5D general health questionnaire (3 months and 12 months post injection). The EQ‐5D is a standardised instrument used 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 endpoints are labelled 'best imaginable health state' and 'worst imaginable health state'. This information can be used as a quantitative measure of health outcomes as judged by individual respondents Relationship of pre‐injection Hospital Anxiety and Depression Scale (HADS) score to outcomes (at 3 months and 12 months post injection). 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 ‐ 7 related to anxiety and 7 related to depression. Each item is scored from 0 to 3, with higher scores indicating higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21, with scores categorised as follows: normal 0 to 7, mild 8 to 10, moderate 11 to 14, and severe 15 to 21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress. Before completing the scale, patients are asked to ensure the answers that they give reflect how they have been feeling during the past week. Change in HADS score at 12 months compared to baseline
Starting date	June 2009
Contact information	Contact: Adam C Watts; +441257256365; Adam.C.Watts@wwl.nhs.uk
Notes	Status: recruiting ClinicaTrials (accessed 26 July 2019)