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Completed

NCT Number: NCT03931824

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Hemiplegia, Infantile Joint Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Paralysis Pathological Conditions, Signs and Symptoms Shoulder Impingement Shoulder Impingement Syndrome Shoulder Injuries Shoulder Subluxation Signs and Symptoms Spasticity, Muscle Stroke Vascular Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP

Other

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.

Other names: Platelet rich plasma injections

Exercise

Other

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.

Other names: Rehabilitation

Primary outcomes

  1. Visual Analogous Scale

    Time frame: 3 months

    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 outcomes

  1. Shoulder ranges of motion

    Time frame: 3 months

    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.

  2. Functional Independence Measure(FIM)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2019
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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