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

Study Overview
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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.

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

Conditions
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Adhesive Capsulitis of Shoulder, Adhesive Capsulitis, Frozen Shoulder

Intervention / Treatment
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* Biological: PRP
* Other: Saline injection


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br>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. | Biological: PRP<br>* 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.<br>* Other names: Platelet Rich Plasma;|
| Placebo Comparator: Placebo<br>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. | Other: Saline injection<br>* 2 ml's of NaCl solution with 0,9% concentration was applied to the shoulders of the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |