Calcific TendinitisNCT02173743
Platelet-rich Plasma in Calcific Tendinitis
A study testing PRP in people with Calcific Tendinitis, run by Orthopedisch Centrum Oost Nederland at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Calcific Tendinitis
- What is being tested?
- PRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2014to 13 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Orthopedisch Centrum Oost Nederland/ZGT
Hengelo, Overijssel, 7550 AM
About this study
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
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
- Being tested
- PRP, Control
- Keywords
- plasma, calcific tendinitis, rotator cuff, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
platelet enriched autologous blood plasma
ControlOther
Regular barbotage/care as usual
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | PRP during barbotage Receives: Other: PRP |
| Control group | Other | Regular barbotage Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) pain
Score to assess the amount of pain
Measured: 6 months post barbotage
Secondary outcomes (2)
Constant-Murley Score (CMS)
To assess shoulder function
Measured: 6 weeks, 3 - 6- 12- 25 months post barbatoge
Quality of Life (EQ-5D)
score to assess the quality of life
Measured: 6 weeks, 3- 6- 12- 24 months post barbotage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startJul 2014
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcific TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedisch Centrum Oost Nederland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edwin Ooms, PhD, Study director, OCONRianne Huis in 't Veld, PhD, Study director, OCONBart Oudelaar, MSc, Principal investigator, OCON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173743
- Sponsor's protocol ID
- NL47402.044.13
- Other IDs
- ABR 47402
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2014
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33566629
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02173743
- Acronym / sponsor ID
- NL47402.044.13
- Conditions
- Calcific Tendinitis
- Keywords
- plasma, calcific tendinitis, rotator cuff, PRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Orthopedisch Centrum Oost NederlandUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Other: PRPPRP during barbotage |
| Control group | Other | Other: ControlRegular barbotage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPplatelet enriched autologous blood plasma | Other | PRP group |
| ControlRegular barbotage/care as usual | Other | Control group |
Primary outcome
Numeric Rating Scale (NRS) pain
Time frame: 6 months post barbotage
Score to assess the amount of pain
2 secondary outcomes
Constant-Murley Score (CMS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 33566629Oudelaar 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.
- hospital's urlLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Ooms, PhD study director
OCON
Rianne Huis in 't Veld, PhD study director
OCON
Bart Oudelaar, MSc principal investigator
OCON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Calcific Tendinitis, run by Orthopedisch Centrum Oost Nederland at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) pain (time frame: 6 months post barbotage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.