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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Numeric Rating Scale (NRS) pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control group
Regular barbotage
Intervention: Control (Other)
PRP group
PRP during barbotage
Intervention: PRP (Other)
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS) pain
Time Frame: 6 months post barbotage
Score to assess the amount of pain
Secondary Outcomes
- Constant-Murley Score (CMS)(6 weeks, 3 - 6- 12- 25 months post barbatoge)
- Quality of Life (EQ-5D)(6 weeks, 3- 6- 12- 24 months post barbotage)