Platelet-rich Plasma in Calcific Tendinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-05-13

Brief Summary

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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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Detailed Description

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Conditions

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Calcific Tendinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PRP group

PRP during barbotage

Group Type EXPERIMENTAL

PRP

Intervention Type OTHER

platelet enriched autologous blood plasma

Control group

Regular barbotage

Group Type OTHER

Control

Intervention Type OTHER

Regular barbotage/care as usual

Interventions

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PRP

platelet enriched autologous blood plasma

Intervention Type OTHER

Control

Regular barbotage/care as usual

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No