Platelet-rich Plasma in Calcific Tendinitis

April 17, 2026 updated by: Orthopedisch Centrum Oost Nederland

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Hengelo, Overijssel, Netherlands, 7550 AM
        • Orthopedisch Centrum Oost Nederland/ZGT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP group
PRP during barbotage
Other: PRP
platelet enriched autologous blood plasma
Other: Control group
Regular barbotage
Other: Control
Regular barbotage/care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) pain
Time Frame: 6 months post barbotage
Score to assess the amount of pain
6 months post barbotage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant-Murley Score (CMS)
Time Frame: 6 weeks, 3 - 6- 12- 25 months post barbatoge
To assess shoulder function
6 weeks, 3 - 6- 12- 25 months post barbatoge
Quality of Life (EQ-5D)
Time Frame: 6 weeks, 3- 6- 12- 24 months post barbotage
score to assess the quality of life
6 weeks, 3- 6- 12- 24 months post barbotage

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon recovery
Time Frame: 6 weeks, 3-6-12-24 months post barbotage
to visualize tendon recovery by ultrasound
6 weeks, 3-6-12-24 months post barbotage
calcifications
Time Frame: baseline, 3 + 12 months post barbotage
size of calcifications (X-ray)
baseline, 3 + 12 months post barbotage
plated plasma analysis
Time Frame: baseline
trombocytes analysis of PRP blood
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopedisch Centrum Oost Nederland

Investigators

  • Study Director: Edwin Ooms, PhD, OCON
  • Study Director: Rianne Huis in 't Veld, PhD, OCON
  • Principal Investigator: Bart Oudelaar, MSc, OCON

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

May 13, 2019

Study Completion (Actual)

May 13, 2019

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimated)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL47402.044.13
  • ABR 47402 (Other Identifier: Medical Ethical Committee Twente)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Calcific Tendinitis

Clinical Trials on PRP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe