Therapeutic efficacy and safety of home-based portable laser irradiation on patients with wrist pain: a single-blinded randomized controlled trial.

The purpose of this study is to confirm the effect of small, portable low-level laser therapy (light sources in square configuration: 830 nm GaAs diode 3.2 mW at the center, 4 × 650 nm InGaAIP diodes over the corners) treatment in reducing and enhancing hand function in patients with wrist pain. This study was a prospective, randomized, sham-controlled, and home-based self-therapy trial. A total of thirty subjects with wrist pain were enrolled. All participants received low-level laser therapy on painful area at the wrist. The experimental group (n = 15) received laser stimulation, while the control group (n = 15) received sham stimulation using identical equipment that generated only a red light without the laser output. Both groups self-treated for 30 min a day, 5 days per week for 3 weeks, total of 15 sessions. The primary outcome was assessed using a visual analogue scale (VAS) for wrist pain from 0 (painless) to 10 (extreme pain). The secondary outcomes were measured with patient-rated wrist evaluation (PRWE), grip strength, lateral, palmar, and tip pinch strength. Measures were taken before and after treatment. A total of thirty participants provided outcome data. After the intervention, both groups showed a significant decrease in VAS score, from 4.93 to 3.67 in experimental group, from 5.53 to 4.00 in control group (the experiment group: p = 0.020, the control group: p = 0.003). The experimental group showed a significant improvement in function scale score (p = 0.012), the control group did not. Lateral and pinch strength was significantly improved in the experimental group (p = 0.017) and in the control group (p = 0.034) respectively. There were no side effects in the patients. Medical laser irradiation is a portable and easy-to-use laser irradiator without side effects. Clinical Trial Registration number: KCT0006604.

Home-Based Intermittent Pneumatic Compression Therapy: The Impact in Chronic Leg Lymphedema in Patients Treated for Gynecologic Cancer.

We conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby gently facilitate lymphatic draining of proximal extremities. Thirty patients with stage 3 chronic secondary unilateral leg lymphedema in the maintenance phase underwent IPC and conventional compression therapy for 4 weeks at home. The participants were guided to use 1 h course (30 min of MLD-mimicking mode and 30 min of conventional mode) of IPC device twice a day for 4 weeks. We assessed the patients' limb-volume measurement, quality of life (QOL), and satisfaction four times. There were no significant time-dependent interactions in the inter-limb volume difference ratio (Vratio). In a subgroup analysis, participants who used the home-based IPC device and maintained their routine self-maintenance program of short-stretch bandages (group B, n = 21) showed a more significant decline in Vratio than those who did not maintained their routine care (group A, n = 9). All scores of QOL decreased significantly after the intervention without subgroup difference. All participants were satisfied with the 4-week intervention. This study demonstrated that a home-based IPC device with an MLD-mimicking program is a useful option for maintaining the volume of limbs and improving the QOL of patients with stage 3 chronic leg lymphedema during the maintenance phase.

Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial.

Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.

Efficacy and Safety of a Stimulator Using Low-Intensity Pulsed Ultrasound Combined with Transcutaneous Electrical Nerve Stimulation in Patients with Painful Knee Osteoarthritis.

Objective: Studies regarding the combination of ultrasound and transcutaneous electrical nerve stimulation (TENS) are rarely reported. In this study, we aimed to elucidate the efficacy and safety of a stimulator using low-intensity pulsed ultrasound (LIPUS) combined with TENS in patients with painful knee osteoarthritis (OA). We evaluated the effectiveness of this therapy against pain, physical function, and cartilage regeneration. Moreover, we aim to prove the superiority of the effects of LIPUS combined with TENS therapy compared with only TENS therapy. Methods: Of the 40 included patients, aged 45-85 years with painful knee OA, 20 patients received only TENS therapy and 20 patients received LIPUS combined with TENS therapy for 8 weeks (a total of more than 80 treatment sessions). We evaluated visual analogue scale (VAS), Western Ontario and McMaster Universities (WOMAC) osteoarthritis index, MOS 36-Item Short-Form Health Survey (SF-36), and femoral articular cartilage (FAC) thickness. The evaluation was performed at three visits: visit 1 (V1, pretreatment, within 28 days after screening), visit 2 (V2, posttreatment period 1, ±3 days after treatment), and visit 3 (V3, posttreatment period 2, 21 ± 3 days after treatment). Results: We expected that LIPUS combined with TENS therapy would be superior to only TENS therapy. However, there was no significant difference between the two therapies. In the within-group comparison, both treatments (only TENS therapy and LIPUS with TENS therapy) demonstrated statistical differences from baseline values for pain and physical function outcomes. FAC thickness showed no significant differences after treatment in both groups. Conclusion: The effects of a stimulator using LIPUS with TENS on pain relief and functional improvement were not superior to the only TENS therapy. Cartilage regeneration, which was expected as an additional benefit of LIPUS, was also not significantly evident. Therefore, further investigation is warranted to determine whether the combination therapy is beneficial. This trial is registered with KCT0003883.

Effects of a Newly Developed Therapeutic Deep Heating Device Using High Frequency in Patients with Shoulder Pain and Disability: A Pilot Study.

Objectives: The newly developed therapeutic deep heating device can generate deep heat in focal tissue using high-frequency wave stimulation. The objective of this study was to evaluate and compare the effectiveness of this deep heating device (HIPER-500®) with ultrasound in alleviating pain and improving function in patients with shoulder disability. Methods: This noninferiority trial was designed to compare the treatment effect of HIPER-500® to that of SonoStim® (ultrasound) on shoulder pain and disability. Thirty-eight patients with shoulder problems were assigned to either the HIPER-500® or SonoStim® group, and each participated in 10 min therapy sessions, five days a week for two weeks (for a total of ten sessions). Shoulder pain and disability were evaluated using the Visual Analogue Scale (VAS), the University of California at Los Angeles score (UCLA score), the Shoulder Pain and Disability Index (SPADI), and the Constant score in both groups before, immediately after, and four weeks after treatment. Statistical analysis was performed to compare the effects of treatment within and between the groups. Results: A total of 34 patients completed the study. The 18 patients in the HIPER-500® group and 16 patients in the SonoStim® group all showed significant improvements in shoulder pain and function when comparing pretreatment values with the results immediately after treatment and four weeks later. The results before and after treatment did not show a statistically significant difference between the two groups. Conclusions: The newly developed HIPER-500® for high-frequency deep heat therapy showed similar effects to those of SonoStim® for relieving pain and improving physical performance in the patients of this study. HIPER-500® may be a useful modality for treating shoulder pain and improving physical activity in patients with shoulder disease.

Supplementation with extract of Gynostemma pentaphyllum leaves reduces anxiety in healthy subjects with chronic psychological stress: A randomized, double-blind, placebo-controlled clinical trial.

BACKGROUND: The ethanol extract of Gynostemma pentaphyllum Makino leaves (EGP) has been reported recently to have anxiolytic effects on chronically stressed mice models. PURPOSE: We aimed to investigate the efficacy and safety of EGP on anxiety level in healthy Korean subjects under chronic stressful conditions. STUDY DESIGN: Double-blind, placebo-controlled trial. METHODS: This study was conducted with 72 healthy adults who had perceived chronic stress and anxiety with a score on the State-Trait Anxiety Inventory (STAI) from 40 to 60. Participants were randomly assigned to receive either EGP (200 mg, twice a day, N = 36) or placebo (N = 36). All participants were exposed to repetitive loads of stress by performing the serial subtraction task for 5 min every second day during the 8-week intervention. Primary outcome of Trait-STAI and secondary outcomes of State-STAI, total score of STAI, Hamilton Anxiety Inventory (HAM-A), Beck Anxiety Inventory (BAI), blood norepinephrine and adrenocorticotropic hormone (ACTH), salivary cortisol and alpha-amylase, cardiovascular autonomic nervous system (ANS) functional test, and heart rate variability (HRV) test were measured before and after intervention. RESULTS: After the 8-week intervention, the EGP significantly lowered the score of the Trait Anxiety Scale of the STAI (T-STAI) by 16.8% compared to the placebo (p = 0.041). The total score on the STAI decreased by 17.8% in the EGP group and tended to improve compared with that of the placebo group (p = 0.067). There were no significant differences in the changes in score of S-STAI, HAM-A, BAI, and other parameters from baseline between the two groups. There was no causal relationship between the ingestion of EGP and adverse drug reactions. CONCLUSION: We found that supplementation with EGP reduced "anxiety proneness" in subjects under chronic psychological stress, as shown by a decrease in the score of T-STAI and the tendency for decrease in the total score of STAI. This result suggests that EGP supplementation can be used as a regimen to safely reduce stress and anxiety; however, more studies are needed to establish the long-term safety and effectiveness.

Effects of dual transcranial direct current stimulation on post-stroke unilateral visuospatial neglect.

Based on the interhemispheric inhibition model of unilateral visuospatial neglect (USN) after stroke, the effects of dual-mode transcranial direct current stimulation (tDCS) over the parietal cortices were assessed in a double-blind random-order cross-over experiment. Ten chronic right hemispheric stroke patients (4 men; mean age: 62.6 years) with USN were recruited. All participants underwent three randomly arranged tDCS sessions: (1) dual-mode, anodal tDCS over the right posterior parietal cortex (PPC) and cathodal tDCS over the left PPC; (2) single-mode, anodal tDCS over the right PPC; and (3) sham mode. Each session lasted 20min. Before and immediately after the stimulation, a line bisection test and star cancelation test were carried out. In the line bisection test, significant improvements were observed after both the dual- and the single-mode tDCS (p<0.05), but not after sham stimulation. Statistical analysis showed a significant interaction between time and tDCS mode, where the dual tDCS had a stronger effect than the single or sham stimulation modes (p<0.05). The star cancelation test did not show any significant change. These results suggest that dual tDCS over the bilateral PPC is an effective method for the treatment of USN in stroke patients.

Enhancing the working memory of stroke patients using tDCS.

OBJECTIVES: We investigated whether anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex affected the working memory performance of patients after a stroke. DESIGN: Ten patients (mean age 47.7 yrs) with cognitive deficits after a first-ever stroke participated in this single-blind, crossover, and sham-controlled experiment. Each patient was randomly assigned to undergo two transcranial direct current stimulation sessions: anodal dorsolateral prefrontal cortex and sham stimulation within 48 hrs of a washout period. All participants performed a two-back working memory task before and after the administration of the transcranial direct current stimulation. Accuracy (correction rate), recognition accuracy (correction rate-commission error rate), and response time were measured during each experiment. RESULTS: Repeated-measures analysis of variance indicated a significant interaction effect of transcranial direct current stimulation type and time on the recognition accuracy. Post hoc analyses revealed a significant difference between prestimulation and poststimulation in the anodal stimulation group but not in the sham stimulation group. Regarding the accuracy, the paired t test indicated significant improvement only after anodal transcranial direct current stimulation without a significant interaction effect between the two transcranial direct current stimulation types. The response time was not significantly different in the anodal and sham stimulation groups. CONCLUSION: Our results demonstrated that anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex was associated with enhanced working memory performance as indexed by the recognition accuracy in patients after a stroke.

Improvement of visual scanning after DC brain polarization of parietal cortex in stroke patients with spatial neglect.

Previous studies have demonstrated that transcranial direct current (DC) brain polarization can modulate cortical excitability in the human brain. We investigated the effect of anodal DC brain polarization of right parietal cortex on visuospatial scanning in subacute stroke patients with spatial neglect. The patients underwent two neglect tests - figure cancellation and line bisection - before and immediately after anodal DC or sham in a double-blind protocol. Anodal DC was applied to the scalp over the right posterior parietal cortex (PPC) with an intensity of 2.0 mA for 20 min. Anodal DC brain polarization, but not sham, led to significant improvement in the both neglect tests. These results document a beneficial effect of DC brain polarization on neglect.

Primary motor cortex activation by transcranial direct current stimulation in the human brain.

Transcranial direct current stimulation (tDCS) can modulate motor cortex excitability in the human brain. We attempted to demonstrate the cortical stimulation effect of tDCS on the primary motor cortex (M1) using functional MRI (fMRI). An fMRI study was performed for 11 right-handed healthy subjects at 1.5 T. Anodal tDCS was applied to the scalp over the central knob of the M1 in the left hemisphere. A constant current with an intensity of 1.0 mA was applied. The total fMRI paradigm consisted of three sessions with a 5-min resting period between each session. Each session consisted of five successive phases (resting-tDCS-tDCS-tDCS-tDCS), and each of the phases was performed for 21s. Our findings revealed that no cortical activation was detected in any of the stimulation phases except the fourth tDCS phase. In the result of group analysis for the fourth tDCS phase, the average map indicated that the central knob of the left primary motor cortex was activated. In addition, there were activations on the left supplementary motor cortex and the right posterior parietal cortex. We demonstrated that tDCS has a direct stimulation effect on the underlying cortex. It seems that tDCS is a useful modality for stimulating a target cortical region.