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

Not Applicable

Completed

• Conditions: Shoulder Impingement; Shoulder Pain; Spasticity, Muscle; Hemiplegia, Infantile; Shoulder Subluxation

• Registration Number: NCT03931824
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-07
• Primary Completion: 2015-11-18
• Study Completion: 2015-11-18
• Status Verified: 2019-04
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogous Scale	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 Outcome Measures

Name	Time	Method
Shoulder ranges of motion	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.
Functional Independence Measure(FIM)	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.

Trial Locations

Locations (1)

Ege university school of medicine; 🇹🇷 Izmir, Turkey