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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951896
• Other study ID #: PRP-AC
• Status: Completed
• Phase: Early Phase 1
• Start date: May 3, 2014
• Est. completion date: September 4, 2015

Study information

• Verified date: May 2019
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 4, 2015
• Est. primary completion date: September 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Adhesive Capsulitis of Shoulder
• Bursitis
• Frozen Shoulder

Intervention

Biological:
• PRP
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.All of the injections were done every two weeks, for a total of 3 times using 21 G injection needles with injection technique of posterior approach.

Other:
• Saline injection
2 ml's of NaCl solution with 0,9% concentration was applied to the shoulders of the participants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)	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.	3 months
Primary	Visual Analogous Scales for pain	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	3 months
Secondary	Visual Analogous Scales for disability	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	3 months
Secondary	Shoulder ranges of motions	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.	3 months
Secondary	Analgesic use	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.	3 months