eedling in patients with tennis elbow

Phase 1

Conditions: Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
ateral Elbow Tendinopathy is a common cause for chronic pain in the elbow, where the pain is present for longer than 6 months. Currently, the rationale is that the tendinopathy is the result of the repetitive strain of the hand, wrist and elbow.

Registration Number: EUCTR2018-002822-22-NL

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 114

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effect of Percutaneous Needle Tenotomy (PNT) and structured exercise on function and pain of patients with Lateral Elbow Tendinopathy (LET).;Secondary Objective: Not applicable;Primary end point(s): The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a patient reported outcome measure (PROM) specifically developed for lateral elbow tendinopathy.;Timepoint(s) of evaluation of this end point: Three months after start intervention

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Outcome Measure - a questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.<br>• EQ-5D - a standardized instrument for use as a measure of health outcome<br>• Two questions concerning patiënt satisfaction<br>• Questionnaire concerning adherence to and possible diffuculties with the structured exercise schedule<br>• Pain measured using the numerical rating scale (NRS) ;Timepoint(s) of evaluation of this end point: Three months after start intervention