Platelet-rich Plasma in Calcific Tendinitis

NCT02173743 | Completed DMC

• 2 other identifiers: NL47402.044.13ABR 47402
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcific Tendinitis

Keywords

plasma, calcific tendinitis, rotator cuff, PRP

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) pain

  Score to assess the amount of pain

  6 months post barbotage

Secondary Outcomes (2)

• Constant-Murley Score (CMS)

  6 weeks, 3 - 6- 12- 25 months post barbatoge

• Quality of Life (EQ-5D)

  6 weeks, 3- 6- 12- 24 months post barbotage

Other Outcomes (3)

• Tendon recovery

  6 weeks, 3-6-12-24 months post barbotage

• calcifications

  baseline, 3 + 12 months post barbotage

• plated plasma analysis

  baseline

Study Arms (2)

PRP group

EXPERIMENTAL

PRP during barbotage

Other: PRP

Control group

OTHER

Regular barbotage

Other: Control

Interventions

PRP OTHER

platelet enriched autologous blood plasma

PRP group

Control OTHER

Regular barbotage/care as usual

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedisch Centrum Oost Nederland: lead

Study Sites (1)

Orthopedisch Centrum Oost Nederland/ZGT

Hengelo, Overijssel, 7550 AM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33566629 DERIVED

Related Links

• hospital's url

Study Officials

• Edwin Ooms, PhD

  OCON

  STUDY DIRECTOR

• Rianne Huis in 't Veld, PhD

  OCON

  STUDY DIRECTOR

• Bart Oudelaar, MSc

  OCON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2014
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

NL (1)