Lateral 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.
Conditions
Interventions
Trade Name: Lidocainehydrochloride
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LIDOCAINE HYDROCHLORIDE
Other descriptive name: Lidocaine
Concentration unit: mg/ml milligr
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. • EQ-5D - a standardized instrument for use as a measure of health outcome • Two questions concerning patiënt satisfaction • Questionnaire concerning adherence to and possible diffuculties with the structured exercise schedule • Pain measured using the numerical rating scale (NRS) ;Timepoint(s) of evaluation of this end point: Three months after start intervention | — |
Countries
Netherlands
Contacts
Public ContactSenior researcher
Sint Maartenskliniek
Outcome results
None listed