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Comparing Injection Treatments for Tennis Elbow (CITTE)

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ClinicalTrials.gov Identifier: NCT03984955
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
TRB Chemedica
Information provided by (Responsible Party):
Adam Charles Watts, Wrightington, Wigan and Leigh NHS Foundation Trust

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Tennis Elbow Lateral Epicondylitis Elbows Tendonitis Device: Sodium hyaluronate with mannitol (Ostenil Tendon) Device: Platelet-Rich Plasma Injection Other: Subcutaneous sham injection Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The patient will be blinded/masked to their group allocation: 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.

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.

Primary Purpose: Treatment
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.
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 18, 2022
Estimated Study Completion Date : April 18, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Mannitol

Arm Intervention/treatment
Active Comparator: 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.

Device: 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.

Active Comparator: 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.
Device: 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.
Other Name: Ostenil Tendon

Sham Comparator: 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.
Other: Subcutaneous sham injection
Sham injection will penetrate the skin, but no therapeutic substance will be injected




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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 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.

  2. 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. ]
    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.

  3. 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. ]
    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.

  4. 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. ]
    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.

  5. 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. ]
    See above



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984955


Locations
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United Kingdom
Wrightington Wigan and Leigh NHS Foundation Trust Recruiting
Wigan, Lancashire, United Kingdom, WN6 9EP
Contact: Adam C Watts    +441257256365    Adam.C.Watts@wwl.nhs.uk   
Contact: Maria Moffatt    +44 1257488212    maria.moffatt@wwl.nhs.uk   
Principal Investigator: Adam Watts         
Sponsors and Collaborators
Wrightington, Wigan and Leigh NHS Foundation Trust
TRB Chemedica
Investigators
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Principal Investigator: Adam Watts Wrightington, Wigan and Leigh NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Adam Charles Watts, Wrightington, Wigan and Leigh NHS Foundation Trust:

Publications:
Funk L. (2005) Hyaluronan vs Corticosteroids for Subacromial Impingement of the Shoulder. Osteoarthritis & Cartilage. 13(Suppl A)

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Responsible Party: Adam Charles Watts, Chief Investigator, Wrightington, Wigan and Leigh NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03984955     History of Changes
Other Study ID Numbers: R&D 1026
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tennis Elbow
Tendinopathy
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Mannitol
Hyaluronic Acid
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Protective Agents