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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-03

Study Completion Date

2015-09-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Adhesive Capsulitis of Shoulder Adhesive Capsulitis Frozen Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The injection process was made with injectors coated with opaque adhesive tapes, and were prepared by another researcher who wasn't involved in injection or assessment. The statistical analyses were conducted without knowing the content of the groups.

Study Groups

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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.

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

Saline injection

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BIOLOGICAL

Saline injection

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

Intervention Type OTHER

Other Intervention Names

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Platelet Rich Plasma

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No