S-guided Percutaneous needle tenotomy in Patients with Lateral Elbow Tendinopathy: A multicenter Randomized Controlled Trial

Recruiting

Conditions: lateral elbow tendinopathy
tenniselbow
10043237

Registration Number: NL-OMON46011

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

• Age between 18 and 65 years
• Pain in the elbow present for more than 12 months, unresponsive to conservative treatment
• Sonographically proven tendinopathy (hypervascularisation, deep tendon calcifications, hypoechogenic tendon, erosive cortex)
• Concordant pain during compression with a US Probe in the region of the extensor tendons
• Is able to give informed consent
• Is instructable to follow the exercises

Exclusion Criteria

• Surgery related to the lateral elbow tendinopathy, including Needle Aspiration of Calcific Deposits (NACD)
• Systemic joint disease such as rheumatoid arthritis etc.
• Rupture or clefts >1cm of the extensor tendons
• Detachment of extensor tendons or tears in collateral ligament
• Contraindication for lidocaïne in accordance to the SPC
• Pregnancy
• Use of anti-inflammatory drugs, such as NSAIDs, steroids, methotrexate, anti-TNF, azathioprine
• Use of anticoagulant drugs which is bridged with acetylsalicylate acid
• Physical, emotional or neurological conditions that would compromise the patient*s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple Sclerosis, etc.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a patient reported outcome<br /><br>measure (PROM) specifically developed for lateral elbow tendinopathy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Outcome Measure<br /><br>- a questionnaire designed to measure physical function and symptoms in<br /><br>patients with any or several musculoskeletal disorders of the upper limb.<br /><br>• EQ-5D - a standardized instrument for use as a measure of health outcome<br /><br>• Two questions concerning patiënt satisfaction<br /><br>• Questionnaire concerning adherence and possible difficulties with the<br /><br>structured exercise schedule<br /><br>• Pain measured using the numerical rating scale (NRS)</p><br>