The effect of Platelet-rich Plasma and Corticosteroids in treatment of shoulder Tendinitis

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-5bt6kd
• Date of registration: 05/09/2017
• Prospective Registration: No
• Primary sponsor: Universidade Tiradentes
• Public title: The effect of Platelet-rich Plasma and Corticosteroids in treatment of shoulder Tendinitis
• Scientific title: Comparative study of Platelet-rich Plasma and Corticosteroids in treatment of Rotator Cuff Tendinopathy
• Date of first enrolment: 31/05/2016
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-5bt6kd
• Study type: Intervention
• Study design: Treatment clinical trial, randomized-controlled, parallel, open, two armed, fase 3
• Phase: 3

Countries of recruitment

Brazil

Contacts

• Name: Arthur Rangel Azevedo
• Affiliation: Universidade Tiradentes

• Name: Arthur Rangel Azevedo
• Affiliation: Universidade Tiradentes

Key inclusion & exclusion criteria

Inclusion criteria: age between 18 and 70 years old; positive Neer test; no previous treatment of IV corticosteroids, injectable or oral in the last 12 months; hemoglobin greater than 11g/dl; platelet count greater than 150000/mm³; and signature of the informed consent form.
Exclusion criteria: association with adhesive capsulitis; complete rupture of the rotator cuff in ultrasonography; loss of follow-up and use of oral or parenteral corticosteroids during the study.

Age minimum: 18Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Rotator Cuff Impingment Syndrome

M75.1

Intervention(s)

A12.207.152.693.600

D06.472.040

Experimental group: 26 patients will receive a single subacromial application of platelet rich plasma
Control group: 25 patients will receive a single coirticoid subacromial application of betametasone dipropionate.
Patients are sorted in each group by block randomization, and will be revalued.

Drug

Primary Outcome(s)

Difference between terapeutical responses between the platelet-rich plasma and corticoid groups, observed by comparing results in DASH outcome measure, UCLA Shoulder rating scale and Constant score, through the finding of a probability of significance of less than 5% (p<0,05)

Observed:
There was no significant difference between the use of corticosteroids and platelet rich plasma in the treatment of rotator cuff syndrome, observed by comparison of DASH Outcome Measure questionnaire (p = 0.20, 0.23 and 0.82 at 1 , 3 and 6 months of treatment respectively), UCLA Shoulder Rating Scale (p=0.83, 0.89 at 1 and 3 months of treatment, p <0.05 at 6 months) and Constant Score (0.50, 0,84,0,22), using as a difference indicator a significance probability of less than 5% (p <0.05).

Secondary Outcome(s)

No secondary outcomes were studied in this study

Source(s) of Monetary Support

Universidade Tiradentes

Secondary Sponsor(s)

Universidade Tiradentes