Platelet-rich Plasma in Calcific Tendinitis

Not Applicable

Completed

• Conditions: Calcific Tendinitis
• Interventions: Other: PRP; Other: Control

• Registration Number: NCT02173743
• Lead Sponsor: Orthopedisch Centrum Oost Nederland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Start: 2014-07
• Status Verified: 2019-05
• Primary Completion: 2019-05-13
• Study Completion: 2019-05-13
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP group	PRP	PRP during barbotage
Control group	Control	Regular barbotage

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) pain	6 months post barbotage	Score to assess the amount of pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Orthopedisch Centrum Oost Nederland/ZGT; 🇳🇱 Hengelo, Overijssel, Netherlands