Skip to main content
Clinical Trials/NCT03951896
NCT03951896
Completed
Early Phase 1

Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder

Ege University0 sites32 target enrollmentMay 3, 2014

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Adhesive Capsulitis of Shoulder
Sponsor
Ege University
Enrollment
32
Primary Endpoint
Shoulder Pain and Disability Index (SPADI)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study was done to investigate whether platelet rich plasma(PRP) injections are effective in the management of adhesive capsulitis of the shoulder(AC).Patients were randomized to 2 groups, and one group took PRP injections for 3 times every two weeks, while the other group took saline injections in same frequency and volume. A standardized exercise programme was also applied to all patients.

Patients were then evaluated with Shoulder Pain and Disability Index(SPADI), Visual analogous scales for pain and disability, Ranges of Movements and use of analgesics in before, after and 3rd month of the therapy.

Registry
clinicaltrials.gov
Start Date
May 3, 2014
End Date
September 4, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Funda Atamaz Calis

Professor in Ege University School of Medicine

Ege University

Eligibility Criteria

Inclusion Criteria

  • Being over 18 years old and having a shoulder pain with restriction for 3 months at least, and 9 months at most(Pain VAS being \>40 mm, and loss of ROM for affected side more than %25 of unaffected side).

Exclusion Criteria

  • Subjects were excluded if they had uncontrolled diabetes, active inflammatory diseases, ongoing pregnancy, severe anemia, psychiatric diseases that may affect compliance or cancer. Patients who had a history of trauma, recent injection therapies(\<3 months), surgery or allergy to local anaesthetics, or signs of complex regional pain syndrome, local infections or use of non steroidal anti-inflammatory drugs throughout the study were also excluded.

Outcomes

Primary Outcomes

Shoulder Pain and Disability Index (SPADI)

Time Frame: 3 months

Shoulder Pain and Disability Index (SPADI) is a tool to assess pain and disability in patients with shoulder pain, which was extensively used in studies involving AC of the shoulder6, 15, 16. It consists of 5 questions in pain domain, and 8 questions in disability domain, which were expressed in a visual analogous scale.

Visual Analogous Scales for pain

Time Frame: 3 months

Patients were asked to describe their pain, level of disability or treatment satisfaction on a 10 cm long line, with 0 point being "none", and 10 cm point being "highest possible". The proximity of the marked point to the 0 end was measured, and the results were recorded

Secondary Outcomes

  • Visual Analogous Scales for disability(3 months)
  • Analgesic use(3 months)
  • Shoulder ranges of motions(3 months)

Similar Trials