Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Polydeoxyribonucleotide in the Treatment of Knee Osteoarthritis

OBJECTIVE: To assess the clinical efficacy and safety of intra-articular injection of hyaluronic acid (HA) combined with polydeoxyribonucleotide (PDRN) in patients with knee osteoarthritis in comparison with that of HA alone. METHODS: The current single-center, prospective, randomized, double-blind, controlled study was conducted in 36 patients with knee osteoarthritis at our medical institution. All the eligible patients (n=30) were equally assigned to two treatment arms (trial group ‘HA+PDRN’ and control group ‘HA’). For efficacy assessment, the patients were evaluated for the visual analogue scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Scores (KSS), all of which served as efficacy outcome measures. We monitored time-dependent changes in efficacy outcome measures at baseline and 1, 3 and 6 months. Subsequently, we compared differences in changes in efficacy outcome measures at 6 months from baseline between the two groups. Moreover, we assessed the safety based on the treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs) and any other complications serving as safety outcome measures. RESULTS: There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except ‘Stiffness’, the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05). In our series, there were no TEAEs, ADRs, and any other complications. CONCLUSION: Intra-articular injections of HA combined with PDRN can also be considered in the treatment of knee osteoarthritis. However, further large-scale and multi-center studies are required to demonstrate the potential of the proposed combination.

Efficacy and Safety of Caregiver-Mediated Exercise in Post-stroke Rehabilitation

OBJECTIVE: To assess the efficacy and safety of our 4-week caregiver-mediated exercise (CME) in improving trunk control capacity, gait, and balance and in decreasing concerns about post-stroke falls when there is an increase in its efficacy. METHODS: Acute or subacute stroke survivors were assigned to either the trial group (n=35) or the control group (n=37). Changes in Modified Barthel Index (MBI), Functional Ambulation Categories (FAC), Berg Balance Scale (BBS), and Trunk Impairment Scale (TIS) scores at 4 weeks from baseline served as primary outcome measures. Correlations of primary outcome measures with changes in Fall Efficacy Scale-International (FES-I) scores at 4 weeks from baseline in the trial group served as secondary outcome measures. Treatment-emergent adverse events (TEAEs) served as safety outcome measures. RESULTS: There were significant differences in changes in MBI, FAC, BBS, TIS-T, TIS-D, TIS-C, and FES-I scores at 4 weeks from baseline between the two groups (all p < 0.0001). There were no significant (p=0.0755) differences in changes in TIS-S scores at 4 weeks from baseline between the two groups. MBI, FAC, BBS, and TIS scores showed significantly inverse correlations with FES-I scores in patients receiving CME. There were no TEAEs in our series. CONCLUSION: CME was effective and safe in improving the degree of independence, ambulation status, dynamic and static balance, trunk function, and concerns about post-stroke falls in stroke survivors.

Research Designs and Statistical Methods Trends in the Annals of Rehabilitation Medicine

OBJECTIVE: To investigate trends of the research designs and statistical methods in the Annals of Rehabilitation Medicine (ARM) published from 2005 to 2015 through a comparison of articles with the Archives of Physical Medicine and Rehabilitation (APMR). METHODS: The authors reviewed all articles published in ARM and APMR for the years 2005 and 2015 in order to determine their research designs as well as their statistical methods used in each article. RESULTS: In ARM, randomized controlled trials increased from 4.5% in 2005 to 6.5% in 2015. In APMR, randomized controlled trials increased from 8.1% in 2005 to 14.0% in 2015, meta-analyses increased to 5.3%, and systematic reviews increased to 6%. The number of studies using statistical methods increased in ARM from 1.9 to 2.6 per article and in APMR, from 2.7 to 3.1. Use of advanced methods in ARM also showed an increase from 2005 to 2015. CONCLUSION: This study concludes that there is a trend of increased awareness and attempts to use varied research approaches in ARM articles. There should also be more in-depth discussions and opportunities for researchers to share their experiences regarding statistical methods in the clinical field.