Dataset Information

Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study.

ABSTRACT: Osteoarthritic knee (OA knee) is a common condition in the elderly. Exploration of non-invasive complementary therapies for OA knee is warranted given the limitations of pharmacologic therapies. Auriculotherapy (AT) is a therapeutic method in which specific points on the auricle are stimulated to treat various disorders of the body, and the therapeutic value and synergistic effect of laser auriculotherapy (LAT) when combined with magneto-auriculotherapy (MAT) merits further investigation.This study adopted a double-blinded four-arm randomized placebo design. The aims of study are (1) to assess the feasibility of AT among elders with OA knee in a future large-scale study, including the use of blinding in subjects and evaluators, acceptance of treatment protocol, and estimating the effect size and attrition rate; and (2) to evaluate the preliminary effect of AT in elders with OA knee. Subjects were randomly divided into four groups with different modes of AT with/without placebo objects. A total of 43 subjects completed the 6-week intervention and post-assessment. Assessments included a numerical rating scale of pain (NRS), the timed-up-and-go test (TUGT), and standard goniometer measurements during knee flexion and extension, Kruskal-Wallis test was used to evaluate differences among groups, and Wilcoxon sign-ranked test for examining within-group comparison.Preliminary results indicated the absence of differences in the NRS, TUGT, and active/passive knee flexion and extension at baseline, as well as post-therapy, between the four groups. Even though the differences of these parameters between groups were not significant, the relative differences of NRS and TUGT in subjects who received combined MAT plus LAT were higher than those treated with MAT or LAT alone, or the placebo group. Four of the six parameters demonstrated significant within group differences in subjects who received MAT and/or LAT, whereas no significant differences were found in the placebo group.This study demonstrates that the AT protocol adopted in this study for elders with OA knee is feasible and could be applied in future larger-scale study. Larger sample size should be considered in a future trial to determine the causal relationship between treatment and effect.ClinicalTrials.gov: NCT02352636 . Registered on 23 January 2015.

SUBMITTER: Suen LK

PROVIDER: S-EPMC4966810 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study.

Suen Lorna K P LK Yeh Chao Hsing CH Yeung Simon K W SK

BMC complementary and alternative medicine 20160729

<h4>Background</h4>Osteoarthritic knee (OA knee) is a common condition in the elderly. Exploration of non-invasive complementary therapies for OA knee is warranted given the limitations of pharmacologic therapies. Auriculotherapy (AT) is a therapeutic method in which specific points on the auricle are stimulated to treat various disorders of the body, and the therapeutic value and synergistic effect of laser auriculotherapy (LAT) when combined with magneto-auriculotherapy (MAT) merits further in ...[more]

PMID: 27473749

Similar Datasets

Project description:BackgroundInsomnia is common amongst the elderly. With the adverse effects of prolonged use of hypnotics, the exploration of noninvasive and nonpharmacological complementary methods for insomnia is warranted. Auriculotherapy (AT) is a therapeutic approach where specific points on the auricle are stimulated to manage various physiological disorders. The purpose of this study is to determine the desirable treatment modality using AT to improve the sleep conditions of the elderly.MethodsA three-arm double-blinded randomised trial was conducted on 145 eligible subjects. This study investigated three minimally invasive procedures, namely, laser auriculotherapy (LAT), magneto-auriculotherapy (MAT), and their combination. Seven auricular points were used. Treatment was performed three times a week, for six weeks. Subjects were assessed at baseline, six weeks, and follow-up after six weeks, three months, and six months. Generalised estimating equations were used to evaluate interactions amongst the groups over time based on the Pittsburgh Sleep Quality Index (PSQI), sleep parameters using actigraphic monitoring, health-related quality of life (HRQOL) using SF-12, and PHQ-9 for depression status.ResultsThe treatment effects of the three procedures were comparable. Significant improvements were found in all of the subjective measures (PSQI, HRQOL, and PHQ-9) for individual groups over time. Improvements in the objective sleep parameters using actigraphic monitoring were detected in subjects who received MAT procedures but not in those who received LAT. The combined MAT and LAT approach did not show any advantage over MAT.ConclusionsThe treatment effects of the three procedures were comparable in subjective parameters but not by objective measures using actigraphic monitoring. Longer therapeutic course and more frequent administration of LAT may be considered in future trials to achieve the optimal treatment effect.Trial registrationThis trial is registered with ClinicalTrials.gov: NCT02970695, registered May 2016.

Project description:IntroductionKnee osteoarthritis is a common form of arthritis in elderly patients that is characterised by pain and functional limitation. Moxibustion has been employed to relieve chronic pain as an alternative therapy for knee osteoarthritis. However, the evidence of its efficacy is equivocal due to the low methodological quality in most clinical studies. Therefore, we are performing a double-blinded, double-placebo, randomised controlled trial to evaluate the efficacy of moxibustion in participants with knee osteoarthritis.Methods and analysisThis is a multicentre, double-blinded, double-placebo, randomised controlled clinical trial. 144 eligible participants with knee osteoarthritis will be randomly assigned to two different groups in a 1:1 ratio. Participants in the moxibustion group will undergo active moxibustion plus placebo gel, whereas participants in the control group will receive diclofenac sodium gel plus placebo moxibustion. Each participant will receive 12 sessions of active/placebo moxibustion at three acupoints (ST35, ST36 and EX-LE4) as well as 2 months of follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee will be applied three times per day for 4 weeks. The primary outcome measure will be the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score change at the end of the intervention period from baseline. The secondary outcome measures include changes of other subscales (pain, stiffness and function) of WOMAC, visual analogue scale and patient globalassessment. The safety of moxibustion and diclofenac sodium gel will be assessed at every visit.Ethics and disseminationThis trial has been approved by the Sichuan Regional Ethics Review Committee (permission number: 2015KL-014). The results of this study are expected to provide clinical evidence on the efficacy of moxibustion for pain relief and physical function improvement in patients with knee osteoarthritis. The findings will be submitted for publication in peer-reviewed medical journals and presented at relevant academic conferences.Trial registration numberNCT02769572.

Project description:Background:Knee osteoarthritis (OA) patients often suffer joint pain and stiffness, which contributes to negative changes in body composition, strength, physical performance (function), physical activity and health-related quality of life. To reduce these symptoms and side effects of knee OA, moderate-intensity continuous training (MICT) cycling is often recommended. While resistance training is considered the optimal form of training to improve sarcopenic outcomes, it imposes higher joint loads and requires supervision, either initially or continuously by trained exercise professionals. Therefore, this pilot study sought to gain some insight into the feasibility and potential benefits of high-intensity interval training (HIIT) cycling as an alternative exercise option to MICT cycling for individuals with knee OA. Methods:Twenty-seven middle-aged and older adults with knee OA were randomly allocated to either MICT or HIIT, with both programs involving four unsupervised home-based cycling sessions (?25 min per session) each week for eight weeks. Feasibility was assessed by enrolment rate, withdrawal rate, exercise adherence and number of adverse effects. Efficacy was assessed by health-related quality of life (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Lequesne index), physical function (Timed Up and Go (TUG), Sit to Stand (STS) and preferred gait speed) and body composition (body mass, BMI, body fat percentage and muscle mass). Results:Twenty-seven of the interested 50 potential participants (54%) enrolled in the study, with 17 of the 27 participants completing the trial (withdrawal rate of 37%); with the primary withdrawal reasons being unrelated injuries or illness or family related issues. Of the 17 participants who completed the trial, exercise adherence was very high (HIIT 94%; MICT 88%). While only three individuals (one in the MICT and two in the HIIT group) reported adverse events, a total of 28 adverse events were reported, with 24 of these attributed to one HIIT participant. Pre-post-test analyses indicated both groups significantly improved their WOMAC scores, with the HIIT group also significantly improving in the TUG and STS. The only significant between-group difference was observed in the TUG, whereby the HIIT group improved significantly more than the MICT group. No significant changes were observed in the Lequesne index, gait speed or body composition for either group. Discussion:An unsupervised home-based HIIT cycle program appears somewhat feasible for middle-aged and older adults with knee OA and may produce similar improvements in health-related quality of life but greater improvements in physical function than MICT. These results need to be confirmed in larger randomised controlled trials to better elucidate the potential for HIIT to improve outcomes for those with knee OA. Additional research needs to identify and modify the potential barriers affecting the initiation and adherence to home-based HIIT cycling exercise programs by individuals with knee OA.

Project description:BackgroundSome people with Parkinson's disease (PD) report poorer dynamic postural stability following high-frequency deep brain stimulation of the subthalamic nucleus (STN-DBS), which may contribute to an increased falls risk. However, some studies have shown low-frequency (60 Hz) STN-DBS improves clinical measures of postural stability, potentially providing support for this treatment. This double-blind randomised crossover study aimed to investigate the effects of low-frequency STN-DBS compared to high-frequency stimulation on objective measures of gait rhythmicity in people with PD.MethodsDuring high- and low-frequency STN-DBS and while off-medication, participants completed assessments of symptom severity and walking (e.g., Timed Up-and-Go). During comfortable walking, the harmonic ratio, an objective measures of gait rhythmicity, was derived from head- and trunk-mounted accelerometers to provide insight in dynamic postural stability. Lower harmonic ratios represent less rhythmic walking and have discriminated people with PD who experience falls. Linear mixed model analyses were performed on fourteen participants.ResultsLow-frequency STN-DBS significantly improved medial-lateral and vertical trunk rhythmicity compared to high-frequency. Improvements were independent of electrode location and total electrical energy delivered. No differences were noted between stimulation conditions for temporal gait measures, clinical mobility measures, motor symptom severity or the presence of gait retropulsion.ConclusionsThis study provides evidence for the acute benefits of low-frequency stimulation for gait outcomes in STN-DBS PD patients, independent of electrode location. However, the perceived benefits of this therapy may be diminished for people who experienced significant tremor pre-operatively, as lower frequencies may cause these symptoms to re-emerge.Trial registrationThis study was prospectively registered with the Australian and New Zealand Clinical Trials Registry on 5 June 2018 (ACTRN12618000944235).

Project description:BackgroundTotal knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.Methods and analysisThis prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications.RegistrationClinical Trials.gov, NCT04092153. Registered on 17 September 2019.

Project description:IntroductionIn Sweden, roughly 3000 patients are reoperated each year due to pain and loss of function related to a loosened hip or knee prosthesis. These reoperations are strenuous for the patient, technically demanding and costly for the healthcare system. Any such reoperation that can be prevented would be of great benefit. Bisphosphonates are drugs that inhibit osteoclast function. Several clinical trials suggest that bisphosphonates lead to improved implant fixation and one small study even indicates better functional outcome. Furthermore, in epidemiological studies, bisphosphonates have been shown to decrease the rate of revision for aseptic loosening by half. Thus, there are several indirect indications that bisphosphonates could improve patient-reported outcome, but no firm evidence.Methods and analysisThis is a pragmatic randomised, placebo-controlled, double-blinded, academic clinical trial of a single postoperative dose of zoledronic acid, in patients younger than 80 years undergoing primary total hip or knee replacement for osteoarthritis. Participants will be recruited from two orthopaedic departments. All surgeries will be performed, and study drugs given at Motala Hospital, Sweden. The primary endpoint is to investigate between-group differences in the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score at 3-year follow-up. Secondary outcomes will be investigated at 1 year, 3 years and 6 years, and stratified for hip and knee implants. These secondary endpoints are supportive, exploratory or explanatory. A total of 1000 patients will be included in the study.Ethics and disseminationThe study has been approved by the Regional Ethical Review Board in Linköping (DNR 2015/286-31). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for pharmacological trials. The results will be submitted for publication in peer-reviewed academic journals and disseminated to patient organisations and the media.Trial registration numberEudraCT: No 2015-001200-55; Pre-results.

Dataset Information

Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study.

Publications

Using auriculotherapy for osteoarthritic knee among elders: a double-blinded randomised feasibility study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets