Platelet-rich Plasma in Calcific Tendinitis

Orthopedisch Centrum Oost Nederland80 enrolled

Overview

Needle aspiration of calcific deposits (NACD ) is the treatment of choice for calcific tendinitis which does not respond to conservative treatment. NACD is effective in approximately 70% of the patients.When NACD is not effective, surgery is often the only treatment that remains.Surgery, however, is discouraged by th e Dutch guidelines for diagnosing and treating patients with subacromial pain syndrome.Therefore,both patients and the doctors treating those patients will benefit from a more effective minimal invasive treatment for calcific tendinitis.Injection of platelet-rich plasma (PRP) might, considering its positive effect on tissue repair, be a possible solution here.Previous research investigating the effects of PRP on other tendinopathies did, however, show controversial results. The aim of this double-blind randomized controlled trial is to investigate the effect of the adjuvant application of PRP after NACD on pain reduction ,recovery of shoulder function, tendon recovery,resorption of calcific deposits, the percentage of patients with persistent complaints and quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Calcific Tendinitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 18 yrs * clinical manifestions of tendinitis calcarea (pain, stifness, lock sensations, muscle atrophy) * persistent pain sympoms \>6 months * standardized AP x-ray shows calcific deposit of \> 5mm \& morphologic Type I \& II deposits (classification of Gärtner en Simons) * ineffective intervention \> 2 types of conservative treatment (among which are non-steroidal anti-inflammatory drugs, physiotherapy, local anesthesia injection and/or corticosteroids, extracorporele shock wave therapy) * indication and referral for barbotage by orthopeadic surgeon Exclusion Criteria: * age \> 55 years * morphological type III deposits according to classification of Gärtner and Simons) (as indicated by standardized x-ray AP) * bigliani type III acromion, and acromial spur of acromioclavicular osteovyt * previous (ineffective) barbotage * the existence of other shoulder related injuries next to calcific tendinitis (full-thickness rupture of the rotator cuff, adhesive capsulitis (frozen shoulder), arthrosis of the glenohumeral- or acromioclavicalar joint * shoulder joint instability * shoulder injury due to trauma or previous shoulder surgeries * other types of disorders that could negatively influence the outcomes (rheumatic arthritis. cervical spine disorders, neurological upper extremity disorders, diabetes mellitus, infections, blood disorders, malignity, pregnancy) * known allergic responses to one of the medications applied in the current study (lidocaine, bupivacaine, kenacort) * usage of anti-coagulants other than ascal of plavix

Outcomes

Primary Outcomes

Numeric Rating Scale (NRS) pain

Score to assess the amount of pain

Time frame: 6 months post barbotage

Secondary Outcomes

Constant-Murley Score (CMS)

To assess shoulder function

Time frame: 6 weeks, 3 - 6- 12- 25 months post barbatoge

Quality of Life (EQ-5D)

score to assess the quality of life

Time frame: 6 weeks, 3- 6- 12- 24 months post barbotage