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

NCT03931824 | Completed

• 1 other identifier: PRP-HSP
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Shoulder Pain; Hemiplegia; Shoulder Subluxation; Spasticity; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Shoulder ranges of motion

  3 months

• Functional Independence Measure(FIM)

  3 months

Study Arms (2)

PRP group

EXPERIMENTAL

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.

Other: PRP; Other: Exercise

Placebo group

SHAM COMPARATOR

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.

Other: Exercise

Interventions

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.

Also known as: Platelet rich plasma injections

PRP group

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.

Also known as: Rehabilitation

PRP group; Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32990858 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Shoulder Impingement Syndrome; Hemiplegia; Muscle Spasticity; Stroke

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Shoulder Injuries; Wounds and Injuries; Paralysis; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Physical Medicine and Rehabilitation Department

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: January 7, 2015
• Primary Completion: November 18, 2015
• Study Completion: November 18, 2015
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

TU (1)