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

Primary Purpose

Shoulder Pain, Shoulder Impingement, Hemiplegia, Infantile

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PRP
Exercise
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Hemiplegia, Shoulder Subluxation, Spasticity, Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege university school of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PRP group

Placebo group

Arm Description

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.

Injections containing saline were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used. To provide blindness, all injections were done using injectors coated with non transparent tape. All of the PRP injections were done by the same physician each time, with compliance to preventive measures against complications such as infections. Patients and the physician who applied the injection were blinded to the groups, and the solution was prepared by another researcher who was not blind to the groups.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 26, 2019
Last Updated
April 30, 2019
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT03931824
Brief Title
Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
Official Title
Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 7, 2015 (Actual)
Primary Completion Date
November 18, 2015 (Actual)
Study Completion Date
November 18, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement, Hemiplegia, Infantile, Shoulder Subluxation, Spasticity, Muscle
Keywords
Shoulder Pain, Hemiplegia, Shoulder Subluxation, Spasticity, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Solutions were prepared by an investigator, and injectors were coated with an opaque layer in order to conceal the content from both the one performing the injection and the patients. Data was then analyzed by an investigator who was blind to the study groups
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Sham Comparator
Arm Description
Injections containing saline were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used. To provide blindness, all injections were done using injectors coated with non transparent tape. All of the PRP injections were done by the same physician each time, with compliance to preventive measures against complications such as infections. Patients and the physician who applied the injection were blinded to the groups, and the solution was prepared by another researcher who was not blind to the groups.
Intervention Type
Other
Intervention Name(s)
PRP
Other Intervention Name(s)
Platelet rich plasma injections
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogous Scale
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Shoulder ranges of motion
Description
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.
Time Frame
3 months
Title
Functional Independence Measure(FIM)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ege university school of medicine
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32990858
Citation
Uzdu A, Kirazli Y, Karapolat H, Unlu B, Tanigor G, Calis FA. Efficacy of platelet-rich plasma in the treatment of hemiplegic shoulder pain. Neurol Sci. 2021 May;42(5):1977-1986. doi: 10.1007/s10072-020-04710-0. Epub 2020 Sep 29.
Results Reference
derived

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

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