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

Early Phase 1

Completed

• Conditions: Adhesive Capsulitis of Shoulder; Frozen Shoulder; Adhesive Capsulitis
• Interventions: Other: Saline injection; Biological: PRP

• Registration Number: NCT03951896
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-03
• Primary Completion: 2015-09-04
• Study Completion: 2015-09-04
• Status Verified: 2019-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline injection	For the control group, same amount of blood was sampled and they were given a same amount of waiting time with the other group, with the resulting injection preparate being 2 ml's of 0,9% saline instead.
PRP	PRP	Interventions: A venous blood sample of 8.5 ml were obtained from all patients. For the treatment group, the blood samples were treated with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. The blood was then centrifugated for 5 minutes with RCF 1200 G velocity to clump red blood cells, and then centrifugated for 10 minutes in same velocity to obtain platelet concentrate. 2 ml's of the resulting platelet rich plasma was injected to the shoulder of the subjects.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	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	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 Outcome Measures

Name	Time	Method
Visual Analogous Scales for disability	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
Analgesic use	3 months	Subjects were also asked about their needs of analgesic usage, namely acetaminophen. They were asked to write down each time they took an acetaminophen tablet of 500 mgs. The results were recorded as miligrams.
Shoulder ranges of motions	3 months	Shoulder range of motions were also evaluated at the time points that were mentioned, as secondary outcome measures. All of the measurements were done accordingly to the guidelines of American College of Orthopedic Surgeons by a conventional goniometer18, 19. The researcher who obtained the measurements was an experienced therapist in this field, and was blind to the treatment groups.