Plasma rich in growth factors (PRGF-Endoret) in the treatment of symptomatic knee osteoarthritis: a randomized clinical trial

In a pilot randomized clinical trial, participants aged ≥60 years (n = 35) with physical limitations and symptomatic knee osteoarthritis (OA) were randomized to 12 weeks of lower-body low-load resistance training with blood-flow restriction (BFR) or moderate-intensity resistance training (MIRT) to evaluate changes in muscle strength, pain, and physical function. Four exercises were performed three times per week to volitional fatigue using 20% and 60% of one repetition maximum (1RM). Study outcomes included knee extensor strength, gait speed, Short Physical Performance Battery (SPPB) performance, and pain via the Western Ontario and McMaster Universities OA Index (WOMAC). Per established guidance for pilot studies, primary analyses for the trial focused on safety, feasibility, and effect sizes/95% confidence intervals of dependent outcomes to inform a fully-powered trial. Across three speeds of movement, the pre- to post-training change in maximal isokinetic peak torque was 9.96 (5.76, 14.16) Nm while the mean difference between groups (BFR relative to MIRT) was −1.87 (−10.96, 7.23) Nm. Most other directionally favored MIRT, though more spontaneous reports of knee pain were observed (n = 14) compared to BFR (n = 3). BFR may have lower efficacy than MIRT in this context—though a fully-powered trial is needed to definitively address this hypothesis.

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Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid

The American Journal of Sports Medicine ◽

10.1177/0363546520986867 ◽

2021 ◽

Vol 49 (2) ◽

pp. 487-496

Author(s):

Yong-Beom Park ◽

Jun-Ho Kim ◽

Chul-Won Ha ◽

Dong-Hyun Lee

Keyword(s):

Hyaluronic Acid ◽

Growth Factors ◽

Knee Osteoarthritis ◽

Clinical Outcomes ◽

Clinical Efficacy ◽

Global Assessment ◽

Platelet Rich Plasma ◽

Patient Global Assessment ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

Background: Although platelet-rich plasma (PRP) has potential as a regenerative treatment for knee osteoarthritis, its efficacy varies. Compositional differences among types of PRP could affect clinical outcomes, but the biological characterization of PRP is lacking. Purpose: To assess the efficacy of intra-articular PRP injection in knee osteoarthritis as compared with hyaluronic acid (HA) injection and to determine whether the clinical efficacy of PRP is associated with its biological characteristics. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 110 patients with symptomatic knee osteoarthritis received a single injection of leukocyte-rich PRP (1 commercial kit) or HA. Clinical data were assessed at baseline and at 6 weeks and 3 and 6 months after injection. The primary endpoint was an improvement in the International Knee Documentation Committee (IKDC) subjective score at 6 months, and the secondary endpoints were improvements in scores based on the Patient Global Assessment, the visual analog scale (VAS) for pain, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Samsung Medical Center patellofemoral score. Cell counts and concentrations of growth factors and cytokines in the injected PRP were assessed to determine their association with clinical outcomes. Results: PRP showed significantly improvement in IKDC subjective scores at 6 months (11.5 in the PRP group vs 6.3 in the HA group; P = .029). There were no significant differences between groups in other clinical outcomes. The Patient Global Assessment score at 6 months was better in the PRP group ( P = .035). The proportion of patients who scored above the minimal clinically important difference (MCID) for VAS at 6 months was significantly higher in the PRP group ( P = .044). Within the PRP group, the concentrations of platelet-derived growth factors were high in patients with a score above the MCID for VAS at 6 months. The incidence of adverse events did not differ between the groups ( P > .05). Conclusion: PRP had better clinical efficacy than HA. High concentrations of growth factors were observed in patients who scored above the MCID for clinical outcomes in the PRP group. These findings indicate that concentration of growth factors needs to be taken into consideration for future investigations of PRP in knee osteoarthritis. Registration: NCT02211521 (ClinicalTrials.gov identifier).

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Effects of therapeutic alliance on clinical outcomes in patients with symptomatic knee osteoarthritis undergoing an exercise program: A randomized clinical trial protocol

Medwave ◽

10.5867/medwave.2021.03.8159 ◽

2021 ◽

Vol 21 (03) ◽

pp. e8159-e8159

Author(s):

Iván Cuyul-Vásquez ◽

Jorge Fuentes C

Keyword(s):

Clinical Trial ◽

Knee Osteoarthritis ◽

Therapeutic Alliance ◽

Pain Intensity ◽

Physical Therapists ◽

Exercise Program ◽

Therapeutic Exercise ◽

Pressure Pain ◽

Symptomatic Knee Osteoarthritis ◽

Symptomatic Knee

Background Previous evidence has shown that seniors physical therapists applying electrotherapy and an enhanced therapeutic alliance in their sessions can positively influence the levels of analgesia of patients with chronic low back pain. It is currently unknown if these effects can be achieved in people with symptomatic knee osteoarthritis when receiving treatment focused on therapeutic exercise. Aim To determine the effects of different therapeutic alliance levels during the application of a therapeutic exercise program on pain intensity and pressure pain threshold in patients with symptomatic knee osteoarthritis. Method This will be a randomized, parallel, two-arm, clinical trial. An intervention of three sessions of therapeutic exercise will be applied for one week. Patients aged 45 to 65 years old with a clinical and radiographic diagnosis of knee osteoarthritis will participate. Also, patients with a pain intensity of at least three months duration and 3 to 8 points in a numerical rating scale will be included. Patients will be randomly assigned to a therapeutic exercise experimental group with an enhanced therapeutic alliance (e.g., active listening, personalized conversation, empathy) or limited therapeutic alliance (e.g., one-way verbalization, brief interaction). Physical therapists will be trained in delivering these two levels of the therapeutic alliance. The pressure pain thresholds at the symptomatic knee and the pain intensity will be measured before and after the intervention. Discussion The results of this research will determine the impact of the therapeutic alliance as a nonspecific relevant factor during the application of a therapeutic exercise program in the treatment of patients with symptomatic knee osteoarthritis. Clinical trials registration number NCT04390932

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