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NCT Number: NCT02173743

Platelet-rich Plasma in Calcific Tendinitis

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.

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Key information

Conditions

Calcific Tendinitis

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedisch Centrum Oost Nederland/ZGT

Hengelo, Overijssel, 7550 AM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Other

platelet enriched autologous blood plasma

Control

Other

Regular barbotage/care as usual

Primary outcomes

  1. Numeric Rating Scale (NRS) pain

    Time frame: 6 months post barbotage

    Score to assess the amount of pain

Secondary outcomes

  1. Constant-Murley Score (CMS)

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

    To assess shoulder function

  2. Quality of Life (EQ-5D)

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

    score to assess the quality of life

Other outcomes

  1. Tendon recovery

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

    to visualize tendon recovery by ultrasound

  2. calcifications

    Time frame: baseline, 3 + 12 months post barbotage

    size of calcifications (X-ray)

  3. plated plasma analysis

    Time frame: baseline

    trombocytes analysis of PRP blood

Sponsors and collaborators

Lead sponsor

Orthopedisch Centrum Oost Nederland

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2014
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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