Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931824
• Other study ID #: PRP-HSP
• Status: Completed
• Phase: N/A
• Start date: January 7, 2015
• Est. completion date: November 18, 2015

Study information

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

Clinical Trial Summary

In this study assessing whether platelet rich plasma injections(PRP) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. Patients were randomized into two groups, first getting PRP injections, and other group taking sham injections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 18, 2015
• Est. primary completion date: November 18, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria were being an adult stroke patient with more than two weeks of shoulder pain and restriction, and not having a history of stroke before the recent incident.

Exclusion Criteria:

• Patients with aphasia, severe cognitive or psychiatric disorders, history of trauma, recent injection (<3 months) or surgery on the affected joint, complex regional pain syndrome, infections, pregnancy, thrombocytopenia(<150000 per microliter) or coagulation disorders or severe spasticity of the affected limb(Modified Ashworth Scale >3) were excluded from the study

Related Conditions & MeSH terms

• Hemiplegia
• Hemiplegia, Infantile
• Muscle Spasticity
• Shoulder Impingement
• Shoulder Pain
• Shoulder Subluxation
• Spasticity, Muscle

Intervention

Other:
• PRP
A venous blood sample of 8.5 ml were obtained from patients. For the study group, the blood samples were mixed with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. Resulting material was then centrifugated for 5 minutes with RCF 1200 G speed to clump erythrocytes, and then centrifugated for 10 minutes in same speed to obtain thrombocyte concentrate. 2 ml's of the platelet rich plasma was injected to the shoulder of the subjects. For the sham injection group, same amount of blood was taken and they were given a of waiting time of same duration with the study group, with the resulting preparate being 2 ml's of 0,9% saline instead. PRP solutions were prepared with kits of Easy PRP(Neotec Biotechnology, Istanbul, Turkey). Injections were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used(18, 19). To provide blindness, all injections were done using injectors coated with non transparent tape.
• Exercise
All of the patients were also informed about proper positioning and the standard care for the affected extremity. Their process of neurological rehabilitation was not changed, which was 5 days of the week, one session of 45 minutes a day. They were also given a program of standardized ROM exercises, which included passive and active motions.

Locations

Country	Name	City	State
Turkey	Ege university school of medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogous Scale	Visual Analogous Scales for pain were used as outcome measures. Both resting and activity pain levels were evaluated. 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 motion	Shoulder range of motions were also evaluated as outcome measures. The measurements were done accordingly to the guidelines of American College of Orthopedic Surgeons by a conventional goniometer(20, 21). The researcher who performed the measurements was an experienced in this field, and was blinded to the treatment groups. External and internal rotation, adduction, abduction, flexion and extension of both shoulders were recorded for each group.	3 months
Secondary	Functional Independence Measure(FIM)	Functional Independence Measure(FIM) is used to evaluate independence for the activities of daily living. It was developed to measure the results of the rehabilitation on the patient, and Turkish version of the tool shown to be valid and reliable in 2001. Having motor and cognitive subscales, the higher scores in FIM are interpreted as better functional independence.	3 months