Efficacy of Local Autologous Platelet-Rich Plasma in the Treatment of Pressure Ulcer in Spinal Cord Injury Patients
BACKGROUND Pressure ulcer is one of the common complications occurring in spinal cord injury (SCI) patients. Platelet-rich plasma (PRP) has been found useful in the treatment of pressure ulcers in few studies. The purpose of this study was to evaluate the role of PRP in pressure ulcer healing in comparison to hydrogel dressing in SCI patients. METHODS In this randomized interventional study, 52 patients of SCI having pressure ulcers of grade III/IV were randomized into two groups of 26 each. In group A patients, hydrogel dressing was done while freshly prepared PRP was used in patients of group B. Pressure ulcers were evaluated at baseline and after three weeks and six weeks in terms of ulcer surface area, volume, Pressure Ulcer Scale for Healing (PUSH) score, histopathology, and ulcer healing parameters. Data were collected and quantitative variables were compared using unpaired t-test or Mann-Whitney test between the two groups and qualitative variables were compared using the chi-square test or Fisher's exact test. A p-value of <0.05 was considered statistically significant. RESULTS Baseline characteristics were comparable in both groups. There was a significant improvement in ulcers in terms of surface area, volume, and PUSH score in both the groups but it was comparable (p-value >0.05). There was a significant improvement in the PRP group as compared to the other group in terms of epithelization, granulation, and neovascularization at three and six-week follow-up. CONCLUSIONS This study suggests that PRP is a possible and better alternative to conventional dressing methods for the treatment of pressure ulcers.
Effects of ultrasound-guided platelet rich plasma injection in patients with piriformis syndrome
Journal of back and musculoskeletal rehabilitation. 2021
BACKGROUND Piriformis syndrome (PS) is the common entrapment neuropathy causing buttock pain. Patients are conventionally treated with lifestyle modification, exercise, non-steroidal anti-inflammatory drugs, corticosteroid or botulinum toxin injections. However, some patients may not respond to these conventional treatment methods. Platelet rich plasma (PRP) injection has been shown to be beneficial in various muscular injuries, but its effects have not yet been investigated in PS. OBJECTIVE The aim of this study was to explore the effect of PRP on pain and functional status in patients with PS, and to identify any correlations between clinical changes and demographic features. METHODS A total of 60 patients with PS were randomly separated into two groups (PRP and control groups). All patients received one session of either PRP or saline injection performed under ultrasound guidance. The pain was measured with a visual analog scale (VAS) and Oswestry Disability Index (ODI) scores were noted at three intervals in both groups: before treatment, 1 week after treatment and 1 month after treatment. RESULTS The VAS and ODI scores were improved in both groups. The improvement was more obvious in the PRP group in the first week, and the results were similar for both groups when measured 1 month after the treatment. CONCLUSION Ultrasound-guided PRP injection provided greater improvements in both pain and functional status in patients with PS, starting in the early period after treatment. A repeat injection might be needed for a long-term effect.
Efficacy of platelet-rich plasma in the treatment of hemiplegic shoulder pain
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology. 2020
OBJECTIVE The aim of this study was to examine the effects of platelet-rich plasma (PRP) on pain and functional outcomes in patients with hemiplegic shoulder pain. We compared the effects of PRP against saline solution by designing a double blind, randomized, prospective study. DESIGN Forty-four patients with hemiplegia were included in this study. All patients received a total of 3 injections, 1 week apart. The first group received PRP injections while the second group received placebo injections. After 3 months of follow-up, 40 patients completed the trial. Primary outcome measure was movement-induced pain score (VAS), and secondary outcome measures were spontaneous pain score, shoulder passive range of motion (ROM), functional independence measure score, and the amount of paracetamol used. All subjects were evaluated at baseline, 1 week, 1 month, and 3 months after the completion of the last injection. RESULTS Both groups showed an improvement in spontaneous and movement-related pain scores and shoulder passive ROM values on 1st and 3rd month visits (p < 0.05). No significance difference was detected between groups (p > 0.05). Similarly, FIM scores improved significantly in both groups (p < 0.05) but no difference was found between groups. Paracetamol use did not differ significantly between groups. CONCLUSION The PRP injections were found not to be superior to placebo. Improvements in both groups can be attributed to the use of rehabilitation techniques and exercises in all patients. There is still need for further research to show whether PRP is a treatment option in the course of hemiplegic shoulder pain. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03931824.
A Randomized Double-Blind Controlled Pilot Study Comparing Leucocyte-Rich Platelet-Rich Plasma and Corticosteroid in Caudal Epidural Injection for Complex Chronic Degenerative Spinal Pain
Pain Pract. 2020
OBJECTIVES To compare the efficacy and safety between leucocyte-rich platelet-rich plasma (LR-PRP) and corticosteroid in fluoroscopically guided caudal epidural injection for patients with complex chronic lumbar spinal pain. Study Design A prospective randomized controlled double blinded study METHODS Fifty eligible patients with complex chronic degenerative spinal pain were randomly assigned with 1:1 allocation ratio to receive caudal epidural injection of corticosteroid (triamcinolone acetonide, 60mg) or LR-PRP (isolated from 60 ml autologous blood) under fluoroscopic guidance. Levels of low back pain, quality of life, and complications (or adverse effects) were evaluated at 1, 3, and 6 months after treatment. Pain levels and quality of life were assessed using the visual analog scale (VAS) and short form SF-36, respectively. RESULTS No significant difference was shown at baseline between two groups. Compared with the pretreatment values, there were significant reduction in the VAS score in both groups. Significantly lower VAS score at 1-month follow-up was detected in patients who received corticosteroid injection. However, the scores were lower in the LR-PRP group at 3- and 6-month follow-up. SF-36 questionnaires measured at 6-month showed significant improvement at all domains in the LR-PRP group. There were no complications or adverse effects related with treatment during 6-month follow-up in either group. CONCLUSIONS Both autologous LR-PRP and corticosteroid for caudal epidural injections under fluoroscopic guidance are equally safe and therapeutically effective in patients with complex chronic lumbar spinal pain. However, LR-PRP is superior to corticosteroid for longer pain-relieving effect and improvement in quality of life.
Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial
Journal of tissue engineering and regenerative medicine. 2019
INTRODUCTION Recent studies demonstrated the utility of perineural injection with platelet-rich plasma (PRP) and 5% dextrose (D5W) as novel strategies for treatment of carpal tunnel syndrome (CTS). The present study comprised a prospective, randomized, single-blind, head-to head comparative trial to compare the six-month outcome of perineural injection with PRP or D5W in patients with moderate CTS. METHODS Fifty-two patients with unilateral moderate CTS were enrolled and randomized into two groups: the PRP group received a single 3-cc perineural injection of PRP under ultrasound guidance and dextrose group received a single 3-cc perineural injection of D5W under ultrasound guidance. The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score was used as the primary outcome. Secondary outcomes included cross-sectional area (CSA) of the median nerve and electrophysiological assessments. Evaluations were performed at baseline and at 1, 3, and 6 months post-injection. RESULTS All patients (26 patients per group) completed the study. Compared with the dextrose group, the PRP group demonstrated significant reductions in BCTQ-function at 3 months (p = 0.044), distal motor latency at 6 months (p = 0.028), and CSA at 3 and 6 months (p = 0.010 and 0.018, respectively). CONCLUSIONS A single perineural injection of PRP reduced the CSA of the median nerve more effectively than injection of D5W at 3 and 6 months post-injection for patients with moderate CTS.
Perineural Platelet-Rich Plasma for Diabetic Neuropathic Pain, Could It Make a Difference?
Pain medicine (Malden, Mass.). 2019
OBJECTIVE To evaluate the clinical effect of perineural platelet-rich plasma (PRP) injection for pain and numbness alleviation in diabetic peripheral neuropathy (DPN). STUDY DESIGN A randomized prospective clinical trial. SETTING Pain clinic and Rheumatology and Rehabilitation Departments, Assiut University Hospital. METHODS Sixty adult patients with type II DM accompanied by DPN of at least six months' duration were assessed by modified Toronto Clinical Neuropathy Score (mTCNS) and randomly allocated into two groups. Group I underwent ultrasound-guided perineural PRP injection and medical treatment, and Group II received medical treatment only. Patients were followed up at months 1, 3, and 6 with regard to pain and numbness visual analog scale (VAS) and mTCNS scores. RESULTS Significant improvement was recorded in pain and numbness VAS scale scores in group I vs group II (P ≤ 0.001 during the whole study period for both parameters); at the same time, mTCNS improved in group I in comparison with group II with P = 0.01, 0.001, and <0.001 at months 1, 3, and 6, respectively. CONCLUSIONS Perineural PRP injection is an effective therapy for alleviation of diabetic neuropathy pain and numbness and enhancement of peripheral nerve function.
Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study: A Randomized Clinical Trial
Jama Neurology. 2018
Importance: Young mouse plasma restores memory in aged mice, but, to our knowledge, the effects are unknown in patients with Alzheimer disease (AD). Objective: To assess the safety, tolerability, and feasibility of infusions of young fresh frozen plasma (yFFP) from donors age 18 to 30 years in patients with AD. Design, Setting, and Participants: The Plasma for Alzheimer Symptom Amelioration (PLASMA) study randomized 9 patients under a double-blind crossover protocol to receive 4 once-weekly infusions of either 1 unit (approximately 250 mL) of yFFP from male donors or 250 mL of saline, followed by a 6-week washout and crossover to 4 once-weekly infusions of an alternate treatment. Patients and informants were masked to treatment and subjective measurements. After an open-label amendment, 9 patients received 4 weekly yFFP infusions only and their subjective measurements were unmasked. Patients were enrolled solely at Stanford University, a tertiary academic medical center, from September 2014 to December 2016, when enrollment reached its target. Eighteen consecutive patients with probable mild to moderate AD dementia, a Mini-Mental State Examination (score of 12 to 24 inclusive), and an age of 50 to 90 years were enrolled. Thirty-one patients were screened and 13 were excluded: 11 failed the inclusion criteria and 2 declined to participate. Interventions: One unit of yFFP from male donors/placebo infused once weekly for 4 weeks. Main Outcome and Measures: The primary outcomes were the safety, tolerability, and feasibility of 4 weekly yFFP infusions. Safety end point analyses included all patients who received the study drug/placebo. Results: There was no difference in the age (mean [SD], 74.17 [7.96] years), sex (12 women [67%]), or baseline Mini-Mental State Examination score (mean [SD], 19.39 [3.24]) between the crossover (n = 9) and open-label groups (n = 9). There were no related serious adverse events. One patient discontinued participation because of urticaria and another because of an unrelated stroke. There was no statistically significant difference between the plasma (17 [94.4%]) and placebo (9 [100.0%]) cohorts for other adverse events, which were mild to moderate in severity. The most common adverse events in the plasma group included hypertension (3 [16.7%]), dizziness (2 [11.1%]), sinus bradycardia (3 [16.7%]), headache (3 [16.7%]), and sinus tachycardia (3 [16.7%]). The mean visit adherence (n = 18) was 86% (interquartile range, 87%-100%) and adherence, accounting for a reduction in the total visit requirement due to early patient discontinuation, was 96% (interquartile range, 89%-100%). Conclusions and Relevance: The yFFP treatment was safe, well tolerated, and feasible. The study's limitations were the small sample size, short duration, and change in study design. The results warrant further exploration in larger, double-blinded placebo-controlled clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT02256306.
Prospective, randomized trial of higher goal hemoglobin after subarachnoid hemorrhage
Neurocritical Care. 2010;13((3):):313-20.
BACKGROUND AND PURPOSE In patients with subarachnoid hemorrhage (SAH), higher hemoglobin (HGB) has been associated with better outcomes, but packed red blood cell (PRBC) transfusions with worse outcomes. We performed a prospective pilot trial of goal HGB after SAH. METHODS Forty-four patients with SAH and high risk for vasospasm were randomized to goal HGB concentration of at least 10 or 11. 5 g/dl. We obtained blinded clinical outcomes at 14 days (NIH Stroke Scale and modified Rankin Scale, mRS), 28 days (mRS), and 3 months (mRS), and blinded interpretation of brain MRI for cerebral infarction at 14 days. This trial is registered at www. stroketrials. org. RESULTS Forty-four patients were randomized. Patients with goal HGB 11. 5 g/dl received more PRBC units per transfusion [1 (1-2) vs. 1 (1-1), P < 0. 001] and more total PRBC units [3 (2-4) vs. 2 (1-3), P = 0. 045]. Prospectively defined safety endpoints were not different between groups. HGB concentration was different between study groups from day 4 onwards. The number of cerebral infarctions on MRI (6 of 20 vs. 9 of 22), NIH Stroke Scale scores at 14 days [1 (0-9. 75) vs. 2 (0-16)], and rates of independence on the mRS at 14 days (65% vs. 44%) and 28 days (80% vs. 67%) were similar, but favored higher goal HGB (P > 0. 1 for all). CONCLUSIONS Higher goal hemoglobin in patients with SAH seems to be safe and feasible. A phase III trial of goal HGB after SAH is warranted.