Clinical trial NCT02173743: Platelet-rich Plasma in Calcific Tendinitis
Official title: Calcific Tendinitis of the Rotator Cuff: a Randomized Controlled Trial to the Effects of the Adjuvant Application of Platelet-rich Plasma After Needle Aspiration of Calcific Deposits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcific Tendinitis
Keywords: plasma, calcific tendinitis, rotator cuff, PRP
Lead sponsor: Orthopedisch Centrum Oost Nederland
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale (NRS) pain
timeFrame: 6 months post barbotage
Secondary outcomes:
measure: Constant-Murley Score (CMS)
timeFrame: 6 weeks, 3 - 6- 12- 25 months post barbatoge
measure: Quality of Life (EQ-5D)
timeFrame: 6 weeks, 3- 6- 12- 24 months post barbotage
Other outcomes:
measure: Tendon recovery
timeFrame: 6 weeks, 3-6-12-24 months post barbotage
measure: calcifications
timeFrame: baseline, 3 + 12 months post barbotage
measure: plated plasma analysis
timeFrame: baseline
Locations:
city: Hengelo
country: Netherlands
facility: Orthopedisch Centrum Oost Nederland/ZGT
state: Overijssel
Study officials:
affiliation: OCON
name: Edwin Ooms, PhD
role: STUDY_DIRECTOR
affiliation: OCON
name: Rianne Huis in 't Veld, PhD
role: STUDY_DIRECTOR
affiliation: OCON
name: Bart Oudelaar, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oudelaar BW, Huis In 't Veld R, Ooms EM, Schepers-Bok R, Nelissen RGHH, Vochteloo AJH. Efficacy of Adjuvant Application of Platelet-Rich Plasma After Needle Aspiration of Calcific Deposits for the Treatment of Rotator Cuff Calcific Tendinitis: A Double-Blinded, Randomized Controlled Trial With 2-Year Follow-up. Am J Sports Med. 2021 Mar;49(4):873-882. doi: 10.1177/0363546520987579. Epub 2021 Feb 10.