Global Rating Of Change Research Articles

Synchronous and asynchronous remote core stability exercises in patients with axial spondyloarthritis: a randomized-controlled clinical trial.

Exercise is a key component of axial spondyloarthritis (axSpA) management. As telerehabilitation has become a viable solution for delivering remote care, the effectiveness of core stability exercises via this method remains under-researched. To compare the effects of telerehabilitation-based synchronous versus asynchronous core stability exercises on core muscle endurance, spinal mobility, disease activity, physical function, and quality of life in patients with axSpA. Forty-four patients with axSpA were randomly assigned to a synchronous exercise group (n = 22, 14 females) performing real-time exercises supervised by a physiotherapist, or an asynchronous group (n = 22, 10 females) following pre-recorded exercise videos. Core endurance tests, Bath Ankylosing Spondylitis Disease Activity (BASDAI), Bath Ankylosing Spondylitis Functional (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life Scale (ASQoL), and functional mobility tests (timed-up-and-go and chair stand tests) were used to assess outcomes. Perceived change was evaluated at post-treatment using the 5-point Global Rating of Change (GRoC) scale. The synchronous group demonstrated greater changes in core endurance, BASMI, BASDAI, ASQoL, BASFI, and functional mobility tests (p < 0.05) compared to asynchronous group. Asynchronous group displayed improvement only in core endurance, ASQoL, chair stand test, and some BASMI parameters (p < 0.05). Notably, 100% of participants in the synchronous group reported their condition as improved, compared to 50% in the asynchronous group shown by GRoC. Supervised core stability exercises delivered by using a synchronous telerehabilitation program may provide better outcomes compared to unsupervised video-based exercise program. This study is prospectively registered at Clinicaltrials.gov (NCT06000072).

Effectiveness of multimodal active physiotherapy for chronic knee pain: a 12-month randomized controlled trial follow-up study.

Active physiotherapy (APT) embraces a patient-centered approach, prioritizing self-management within the biopsychosocial model and involving active patient movements. Beyond structured exercise, APT incorporates pain neuroscience education, Mulligan Mobilization (MWM), and active myofascial release techniques to integrate sensory-motor information for functional recovery and pain relief. This study aims to rigorously compare the effectiveness of APT versus conventional physical therapy (CPT) on pain and functional outcomes in patients with chronic knee pain. Eighty-seven patients with symptomatic and radiographically confirmed knee pain were included in this 12-month follow-up of a randomized controlled trial, conducted at a national institute and a rehabilitation clinic. Patients were randomized to either APT (n = 44) or CPT (n = 43). The APT protocol integrated pain neuroscience education, MWM, active myofascial release techniques, and structured exercises focusing on flexibility, stability, neuromuscular control, and coordination. The CPT protocol included health education, laser therapy, ultrasound therapy, and exercise. Both interventions were performed for 60 min twice a week for 3 months. The primary outcome was the Knee Injury and Osteoarthritis Outcome Score-4 domain version (KOOS4). Secondary outcomes included pain intensity (VAS), KOOS-pain, activities of daily living (ADL), function in sport and recreation (Sports/Rec), knee-related quality of life, global rating of change (GROC), quality of life (SF-36), Tampa Scale for Kinesiophobia (TSK), and functional performances measured at different intervals. Intention-to-treat analyses were performed. Of the 87 patients, 70 (80.5%) completed the 12-month follow-up. KOOS4 improved more in the APT group (16.13; 95% CI, 10.39-21.88) than in the CPT group (11.23; 95% CI, 5.42-17.04). APT showed additional improvement in KOOS4 compared to CPT (2.94; 95% CI: 0.04 to 5.85, p = 0.047). The VAS difference was -3.41 mm (95% CI: -6.40 to -0.43, p = 0.025), favoring APT. APT also showed more improvements in KOOS-pain, KOOS-ADL, KOOS-Sports/Rec, and TSK (p < 0.05). No differences between groups were observed in GROC and SF-36. APT significantly improved most functional performance variables compared to CPT (p < 0.05). Active Physiotherapy outshines conventional physical therapy by delivering more substantial reductions in pain intensity and marked enhancements in function among patients with knee pain. This distinctive efficacy underscores the invaluable role of APT in the management of chronic knee pain. By actively involving patients in their recovery journey, APT not only fosters superior results but also emphasizes the critical need to integrate these advanced therapeutic strategies into everyday clinical practices.

Training in the Use of Myoelectric Prostheses Through the Combined Application of Immersive Virtual Reality, Cross-education, and Mirror Therapy

ABSTRACT Introduction During the rehabilitation process (RHB) of the patient with traumatic upper-limb amputation, the use of immersive virtual reality (IVR) facilitates the incorporation of the prosthesis into the body schema. This reinforces and enhances sensorimotor and cognitive stimulation to improve motor learning and motor patterns, while normalizing global gestures. Objectives The aims of this study were to implement retraining of gestural acquisition and prosthetic control in patients with upper-limb injuries and amputations through IVR, and to then incorporate this in the normalization of functional patterns in activities of daily living (ADLs) with the work of “cross-education” as well as the therapy of observation of actions—mirror therapy to enhance the joint effect of the approach with IVR. Methods Standard sessions were established for transradial and transhumeral trauma patients with upper-limb amputation and traumatic injuries within the rehabilitation treatment. During the sessions, games and virtual environment were used. The software ran in desktop mode using a “Leap Motion” or for immersive versions of 3D glasses (Oculus Rift S). Results The application of IVR in combination with conventional treatment obtained significant benefits for functionality. These included learning correct motor execution as well as motivational and emotional state with distal traumatic injuries and upper-limb amputations with or without myoelectric prosthesis, obtaining 5.6 on average on the GROC (global rating of change) scale. Conclusions Immersive virtual reality shows benefit for the normalization of motor learning of functional patterns in DLA and on the emotional, motivational level of the patient. Clinical Relevance The integrated combination of cross-education, mirror therapy, and immersive virtual reality may represent greater acquisition of motor patterns in the prosthetic training of patients with upper-limb amputation.

Minimal Clinically Important Difference of Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI).

To calculate the minimal clinically important difference (MCID) for the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI). Prospective cohort study. A single tertiary care balance and falls center. Fifty-three subjects meeting Barany Society criteria for vestibular migraine (VM) or probable VM were included and divided into 3 treatment groups. Treatment was not standardized, instead, management was decided individually between each patient and their provider. All subjects completed VM-PATHI before and after intervention. A Global Rating of Change (GRoC) questionnaire was also completed following intervention. Anchor-based methods, using a GRoC questionnaire, were utilized to estimate the MCID that produced the highest sensitivity and specificity on a receiver operating characteristic (ROC) curve. Forty-three subjects were classified as responders and 10 were classified as nonresponders. The mean VM-PATHI pretreatment score minus the posttreatment score between the responders (mean = 14, SD 13) and nonresponders (mean = 4 SD = 12) was statistically significant (mean difference = 10, 95% confidence interval, CI [1, 20], P = .03). The VM-PATHI score change cutoff that best differentiated between responders and nonresponders was a VM-PATHI change of 6. Thus, the MCID was defined as a change of 6 points (sensitivity = 72%, specificity = 70%). The area under the ROC curve was 0.89, 95% CI [0.80, 0.98], which demonstrates an excellent ability for the VM-PATHI score change to discriminate between responders and nonresponders. The average change in VM-PATHI scores was 9 points (SD 11) for those with "a little better" rating on the GRoC, 14 points (SD 14) for those with a "moderately better" rating, and 20 points (SD 13) for those with a "very much better" rating. Patients with VM are likely to demonstrate clinical improvement if their VM-PATHI score decreases by 6 or more.

Disentangling effects of droughts and heatwaves on alpine periphyton communities: A mesocosm experiment

AbstractThe accelerating rate of global climate change at higher elevations and latitudes is increasing the potential for extreme climatic events. Here, a knowledge gap exists in how the order of exposure to, and duration of droughts and heatwaves affect their cumulative impact on aquatic communities. We tested experimentally for the legacy effects of simultaneous vs. sequential exposures to drought and heatwave on sediment‐dwelling algal communities (epipelon) from small fishless alpine lakes. In both simultaneous, and sequential exposure treatments involving drought followed by a heatwave, the negative effect of drought masked the effects of warming on chlorophyll‐inferred algal biomass and taxonomic composition. Reversal of order of exposure (i.e., heatwave followed by drought) lowered their cumulative effect on community structure. These findings highlight the potential for drought events to dominate over heatwaves in altering shallow littoral ecosystems at high elevations under a rapidly warming climate.

Progress Toward Estimating the Minimal Clinically Important Difference of Intelligibility: A Crowdsourced Perceptual Experiment.

The purpose of the current study was to estimate the minimal clinically important difference (MCID) of sentence intelligibility in control speakers and in speakers with dysarthria due to multiple sclerosis (MS) and Parkinson's disease (PD). Sixteen control speakers, 16 speakers with MS, and 16 speakers with PD were audio-recorded reading aloud sentences in habitual, clear, fast, loud, and slow speaking conditions. Two hundred forty nonexpert crowdsourced listeners heard paired conditions of the same sentence content from a speaker and indicated if one condition was more understandable than another. Listeners then used the Global Ratings of Change (GROC) Scale to indicate how much more understandable that condition was than the other. Listener ratings were compared with objective intelligibility scores obtained previously via orthographic transcriptions from nonexpert listeners. Receiver operating characteristic (ROC) curves and average magnitude of intelligibility difference per level of the GROC Scale were evaluated to determine the sensitivity, specificity, and accuracy of potential cutoff scores in intelligibility for establishing thresholds of important change. MCIDs derived from the ROC curves were invalid. However, the average magnitude of intelligibility difference derived valid and useful thresholds. The MCID of intelligibility was determined to be about 7% for a small amount of difference and about 15% for a large amount of difference. This work demonstrates the feasibility of the novel experimental paradigm for collecting crowdsourced perceptual data to estimate MCIDs. Results provide empirical evidence that clinical tools for the perception of intelligibility by nonexpert listeners could consist of three categories, which emerged from the data ("no difference," "a little bit of difference," "a lot of difference"). The current work is a critical step toward development of a universal language with which to evaluate changes in intelligibility as a result of neurological injury, disease progression, and speech-language therapy.

Establishing the minimum clinically important difference of the Quality of Life in Childhood Epilepsy Questionnaire.

To estimate the minimum clinically important difference (MCID) for the parent-reported 55-item Quality of Life in Childhood Epilepsy Questionnaire (QOLCE-55) and its shortened 16-item version, QOLCE-16. Data came from 74 children with epilepsy (CWE) (ages 4-10, mean age = 8 [SD = 1.8]) enrolled in the Making Mindfulness Matter in Epilepsy (M3-E) trial, a pilot, parallel randomized-controlled trial of a mindfulness-based intervention. Both anchor-based and distribution-based methods were used to estimate MCID values for the QOLCE-55 and QOLCE-16. For the anchor-based approach, the Patient Centered Global Ratings of Change (PCGRC) scale and linear regression analysis were used to estimate the MCID. For the distribution-based approach, .5 SD of the health-related quality of life (HRQOL) change score distribution was used to estimate the MCID. For the QOLCE-55, the MCID obtained using an anchor-based approach was 10 points and using a distribution-based method was 6 points. For the QOLCE-16, the MCID obtained using an anchor-based method was 13 points and using a distribution-based method was 7 points. This is the first study to estimate MCID values for the QOLCE-55 and the QOLCE-16. It has been well documented that CWE are at risk of experiencing psychological, behavioral, and cognitive impairments, which can negatively impact their HRQOL. Reporting MCID values for the QOLCE-55 and QOLCE-16 is important in determining whether changes in HRQOL observed are meaningful to CWE themselves, as a key factor in shaping the nature of epilepsy care delivered.

Global Rating of Change for Better or Worse-What Does It Mean When Patients Who Are Treated for Patellofemoral Pain Rate Their Change?

OBJECTIVE: To investigate how a global rating of change (GROC) score corresponds to change in Knee injury and Osteoarthritis Outcome Score (KOOS) subscales in people with patellofemoral pain (PFP). DESIGN: Secondary analysis of data from 3 clinical trials. METHODS: Four hundred ninety adolescents (10-18 years old) and adults (19-40 years old) with PFP completed KOOS (5 subscales, 0-100) at baseline and 3-month follow-up as well as GROC at 3-month follow-up. GROC category descriptors were mapped to 5 categories: worse, no change, a bit better, better, and much better. Gaussian approximation was then used to calculate the change in KOOS scores for each GROC category. RESULTS: Due to overlap between KOOS scores in "no change" and "a bit better," all analyses were performed on 4 categories. For all KOOS subscales, patients who reported being "worse" had negative KOOS scale change scores (≤ -2); patients reporting "no change" had KOOS scale change scores that ranged from -5 to 14; and patients feeling "better" or "much better" had positive KOOS scale change scores that ranged from 4 to 26 and ≥16, respectively. CONCLUSION: When patients with PFP reported feeling "worse," "better," or "much better," there was a small-to-substantial change across the different KOOS scales. This is in contrast to no difference between reporting "a bit better" or "no change" in KOOS. When patients say they feel a little better, clinicians should be less confident about whether change has truly occurred. J Orthop Sports Phys Ther 2024;54(10):657-671. Epub 25 July 2024. doi:10.2519/jospt.2024.12120.

Association of Self-Reported Improvement After 4 Weeks and Outcomes After 52 Weeks Among Adolescents With Patellofemoral Pain and Osgood-Schlatter Disease.

Short-term, self-reported changes in symptom severity for musculoskeletal pain disorders may be more strongly associated with long-term prognoses than baseline patient characteristics, because such changes describe a trajectory and not a state. To investigate whether short-term improvement in self-reported symptom severity is associated with long-term recovery among adolescents with nontraumatic knee pain (patellofemoral pain [PFP] or Osgood-Schlatter disease [OSD]). Cohort study; Level of evidence, 3. The authors evaluated data from 2 prospective clinical trials that included adolescents aged 10 to 14 years with either PFP (n = 151) or OSD (n = 51). Both groups underwent a self-management rehabilitation program including activity modification, education, and exercise. The primary outcome was a 7-point global rating of change (GROC) scale (from "much improved" to "much worse"); participants were considered to have improved symptoms if they reported being "much improved" or "improved." Outcomes were collected after 4 and 52 weeks. To investigate whether participants who improved according to GROC scores after 4 weeks were more likely to improve after 52 weeks compared with those who had not improved after 4 weeks, the authors calculated the relative risk (RR) of being improved. Among participants with PFP, reporting an improvement after 4 weeks increased the likelihood of an improvement after 52 weeks (RR = 1.26; 95% CI, 1.06-1.50; P = .008); among those with OSD, reporting an improvement after 4 weeks did not increase the likelihood of an improvement after 52 weeks (RR = 1.06; 95% CI, 0.88-1.28; P = .545). Among participants with PFP who did not improve after 4 weeks, 73% reported improvement after 52 weeks, whereas among participants with OSD who did not improve after 4 weeks, 89% reported improvement after 52 weeks. Self-reported improvement after 4 weeks of treatment was associated with better outcomes after 52 weeks among adolescents with PFP. This association was present only among adolescents with PFP, as almost all adolescents with OSD improved after 52 weeks, regardless of short-term results. Importantly, even among adolescents reporting no improvement after 4 weeks, a large proportion reported improvement after 52 weeks. This highlights the importance of following the rehabilitation program regardless of the short-term response.

Patient-Determined Important Change for the Neck Disability Index With Application of Credibility Analysis: An Exploratory Study

ObjectiveThe purposes of this study were to preliminarily report patient-identified change for the neck disability index (NDI) as either important or not important with time between follow-up of approximately 7 to 10 days and assess the credibility of the preliminary results with the use of a recently established credibility instrument. MethodsThis study was a secondary analysis from a primary randomized clinical trial assessing short-term physical therapist care for individuals with mechanical neck pain. Neck disability index scores and participant-reported importance of global rating of change scores from 42 participants were analyzed from a randomized clinical trial assessing short-term responses to thoracic manipulation and dry needling for neck pain. Patient-important change was computed using receiver operating characteristic curves, and statistical error of the measurement was calculated using (SD × [1 − r]1/2) × 1.96 to assess measurement error at the 95% CI. ResultsThirty-six participants rated global rating of change as important, and 6 rated it as not important. Patient-important change was calculated at 3.5 NDI points on a 0 to 50 NDI scoring scale. This value exceeded the statistical error, which was calculated at 2.16 NDI points. The credibility analysis revealed that 4 of 5 criteria showed strong credibility for the patient-important change estimate. ConclusionUsing patient-determined importance to dichotomize improvement may yield a lower threshold than current researcher-defined methods. Clinically, these results may be more responsive to patient-centric change than using previously reported minimal clinically important difference data.

Associations between lateral hip muscle changes and global rating of change of symptoms in active young adults with long standing hip/groin pain

Associations between lateral hip muscle changes and global rating of change of symptoms in active young adults with long standing hip/groin pain

Are combined conservative interventions effective in reducing pain, disability and/or global rating of pain in people with sciatica with known neuropathic pain mechanisms?

National Clinical Guidelines recommend an integrated combination of conservative management strategies for sciatica. However, the efficacy of such combinations have not been established. The purpose of this systemic review with meta-analysis was to determine the efficacy of combined conservative (non-pharmacological) compared to single interventions for people with sciatica with a confirmed neuropathic mechanism. The systematic review was registered on PROSPERO CRD42023464011. The databases included were the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (EBSCO), Embase, PubMed, Scopus, APA PsycINFO, and grey literature sources from inception until January 2024. Inclusion criteria were randomized controlled trials that assessed the effectiveness of combined non-pharmacological interventions in comparison to a control intervention among individuals with sciatica of a neuropathic origin identified using diagnostic or clinical tests. Primary outcomes were back pain, leg pain, and disability. The secondary outcome was global rating of change. Study selection, data extraction and risk of bias assessment (using Cochrane ROB2) were assessed by two reviewers. Meta-analysis was performed with a random effects model with inverse variance weighting used for the metanalysis using SPSS v 29. 3,370 articles were identified, of which 6 were included. Risk of bias was high in one study and had some concerns in the remaining 5 studies for each outcome measure. There was evidence of efficacy for combined interventions for back pain in the short-and long-term (SMD - 0.56 (95% CI -0.91, -0.22, p = 0.01, I2 = 0.2; SMD - 0.44 (95% CI -0.79, -0.1, p = 0.03, I2 = 0.00), and for disability in the short term (SMD - 0.48 (95% CI -0.92, -0.04, p = 0.04, I2 = 0.72). There was no evidence of efficacy for leg pain at any time point (( short term SMD - 0.45 (95% CI -0.91, 0.02, p = 0.06, I2 = 0.65), medium term (SMD - 0.29 (95% CI -1.12, 0.54, p = 0.35, I2 = 0.82), long term (SMD - 0.40 (95% CI -1.23, 0.44, p = 0.18, I2 = 0.57).Certainty of evidence ranged from very low to moderate. There are few studies that have combined conservative (non-pharmacological) interventions for the management of sciatica with a neuropathic component pain mechanism, as recommended by National Clinical Guidelines. This review indicates that combining conservative (no-pharmacological) management strategies appeared more effective than single interventions for the outcomes of low back pain in the short and long term, and for disability in the short term, but not for leg pain at any time point. The overall low certainty of evidence, suggests that future studies with more robust methodologies are needed.

Sustained acoustic medicine treatment of discogenic chronic low back pain: A randomized, multisite, double-blind, placebo-controlled trial.

Sustained acoustic medicine (SAM) is a noninvasive long-term treatment that provides essential mechanical and thermal stimulus to accelerate soft tissue healing, alleviate pain, and improve physical activity. SAM increases localized deep tissue temperature, blood flow, cellular proliferation, migration, and nutrition exchange, resulting in reduced inflammation and an increased rate of tissue regeneration. To assess the efficacy of SAM treatment of discogenic back pain in the lower spinal column to reduce pain, improve quality of life, and lower pharmacotherapy use. Sixty-five subjects with chronic low back pain were randomly assigned to SAM (N= 33) or placebo (N= 32) groups. Subjects self-applied SAM device bilaterality on the lower lumbar region for 4 hours daily for 8 weeks and completed daily pain diaries before, during, and after treatment. Subjects recorded pain reduction using a numeric rating scale (NRS), medication use, and physical activity using the Global Rating of Change (GROC) and Oswestry Disability Index (ODI). SAM treatment significantly reduced chronic lower back pain from baseline relative to placebo treatment (p< 0.0001). SAM treated subjects reported significantly lower back pain at 4 weeks, with the highest pain reduction (-2.58 points NRS, p< 0.0001) reported at 8 weeks. Similar trends were observed in improved physical activity (3.48 GROC, p< 0.0001, 69-88% ODI, p< 0.0001) and 22.5% (15.2 morphine milligram equivalent) reduction in the use of opioid medication from baseline to 8 weeks. Daily, home-use SAM treatment significantly improves the clinical symptoms of chronic lower back pain, improves physical mobility, and reduces daily medication use. SAM treatment is well-tolerated by patients and may be considered a safe, non-invasive treatment option for chronic discogenic, lower back pain.

The Impact of Blood Flow Restriction Training on Tibial Bone Stress Injury Rehabilitation: An Exploratory Case Series.

Lower extremity bone stress injuries (BSI) are common injuries among athletes and military members. Typical management involves a period of restricted weightbearing which can have rapid detrimental effects upon both muscle and bone physiology. Few studies have investigated the effect of blood flow restriction (BFR) training on bone in the rehabilitative setting. The purpose of this study was to investigate the effects of lower extremity exercise with the addition of BFR upon bone mineral density, bone mineral content, and lean body mass in military members with tibial BSIs. Case series. Twenty military members with MRI-confirmed tibial BSI were recruited to complete lower extremity exercise with the addition of BFR twice per week for four weeks. The BFR cuff was applied proximally to the participant's involved limb while they performed gluteal, thigh, and leg resistance exercises. Outcomes were assessed at baseline and four weeks. The primary outcomes were whole leg bone mineral density (BMD), bone mineral content (BMC), and lean body mass (LM) as measured by dual-energy x-ray absorptiometry. Secondary outcomes included thigh and leg circumference measures and patient-reported outcomes, including the Lower Extremity Functional Scale (LEFS), Patient-Reported Outcomes Measurement Information System 57 (PROMIS-57), and Global Rating of Change (GROC). No significant differences were found in BMD (p=0.720) or BMC (p=0.749) between limbs or within limbs over time. LM was generally less in the involved limb (p=0.019), however there were no significant differences between or within limbs over time (p=0.404). For thigh circumference, significant main effects were found for time (p=0.012) and limb (p=0.015), however there was no significant interaction effect (p=0.510). No significant differences were found for leg circumference (p=0.738). Participants showed significant mean changes in LEFS (15.15 points), PROMIS physical function (8.98 points), PROMIS social participation (7.60 points), PROMIS anxiety (3.26 points), and PROMIS pain interference (8.39 points) at four weeks. The utilization of BFR in the early rehabilitative management of tibial BSI may help mitigate decrements in both bone and muscle tissue during periods of decreased physical loading. 4.

Efficacy and safety of an oral complementary medicine combination in people with symptomatic knee osteoarthritis: Protocol for the double-blind, randomized, placebo-controlled ATLAS trial

ObjectiveTo investigate the efficacy and safety of an oral complementary medicine combination formulation relative to placebo, on changes in pain intensity from baseline to week 12, in people with knee osteoarthritis (OA). DesignA placebo-controlled, double-blind, two-arm, superiority, phase II, Randomized Controlled Trial (RCT) (ACTRN12623000380695). We will recruit 82 participants (∼41 per arm), aged ≥40 years, with a clinical diagnosis of symptomatic knee OA and radiographic change on x-ray (Kellgren-Lawrence Grade ≥2). Participants will be randomly allocated to receive either a complementary medicine formulation containing a daily dose of Boswellia serrata extract (Boswellin® Super, 250 ​mg/day), pine bark extract (Fenoprolic™ 70 Organic 100 ​mg/day), curcumin (500 ​mg/day), piperine (5 ​mg/day), and methylsulfonylmethane (MSM, 1500 ​mg/day), or placebo, for 12-weeks. The primary endpoint will be change from baseline in average knee pain intensity at 12-weeks (visual analogue scale). Secondary endpoints will include change in knee pain from baseline to 12-weeks in the Knee Injury and Osteoarthritis Outcome Score (KOOS), global assessment of disease activity, global rating of change, and health-related quality of life (AQoL-8D). Ethics and disseminationThis protocol has been approved by the University of Sydney Human Research Ethics Committee (#2021/877). Dissemination will occur through lay summaries, infographics, conference abstracts, oral presentations, theses, and scientific publications. ConclusionThis RCT will provide credible evidence about the efficacy and safety of this complementary medicine combination and inform updates to international clinical practice standards on the use of complementary medicines in the management of symptomatic knee OA.

Efficacy of arch contouring foot orthoses for midfoot osteoarthritis: Protocol for a randomised controlled trial.

Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12weeks; the primary endpoint for assessing efficacy being 12weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events. This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Lumbar Spine and Neural Tissue Mobilizations Improve Outcomes in Runners Presenting With Foot/Ankle Pathology: A Case Series.

Foot/ankle pain is common among runners. Inadequate management of runners with foot/ankle pain can lead to lost training time, competition removal, and other activity limitations. Neurodynamics, which refers to the integrated biomechanical, physiological, and structural function of the nervous system during movement, can be overlooked in patients with foot/ankle pain. Although a link between the cervical spine, neurodynamics, and upper quarter pain has been studied, less is known about the relationship between the lumbar spine and lower quarter. This case series describes the successful management of 3 runners with foot/ankle pain. Three female runners (ages 23, 24, and 45y) presented to physical therapy with foot/ankle pain and difficulty running. Each patient had positive examination findings with local foot/ankle testing. A comprehensive lumbar spine examination demonstrated impairments in range of motion and joint mobility that were hypothesized to be contributing. Positive lower quarter neurodynamic tests were also found. All patients were treated with nonthrust lumbar spine mobilization and lower quarter neural tissue mobilization. Changes in the Patient-Specific Functional Scale, Numerical Pain Rating Scale, Lower Extremity Functional Scale, and Global Rating of Change occurred after intervention targeting the lumbar spine and lower-extremity neurodynamics in all patients. This case series demonstrates the importance of including a thorough lumbar spine examination and neurodynamic testing to identify appropriate interventions while managing patients with foot/ankle pain, even when patients have signs indicative of local ankle/foot pathology. These examination procedures should be performed particularly when a patient is not responding to management targeting local foot/ankle structures.

Effect of thoracic manipulation on neck pain in the mobility group: A randomized controlled trial.

Thoracic spine manipulation (TSM) increases the thoracic spine's range of motion (ROM), effectively reducing pain intensity and disability in patients with mechanical neck pain. We aimed to determine the effect of TSM on neck pain intensity and functional impairment in patients classified under the "mobility" category in Childs' classification. In this randomized controlled trial, patients with mechanical neck pain who met the inclusion criteria were randomly assigned to either the TSM (n = 21) or sham manipulation (n = 20) group. The primary outcomes were pain during neck rotation and subjective improvement assessed using the Numerical Pain Rating Scale (NPRS) and Global Rating of Change (GROC), respectively. The secondary outcomes were NPRS at rest, disability (assessed using the Neck Disability Index [NDI]), and ROM of the cervical and thoracic spine rotation. Outcome measurements were performed at baseline, immediately after treatment, 1 week after treatment, and at the 4-week follow-up. Linear mixed models were used to analyze the NPRS, NDI, and ROM. The GROC was analyzed using a chi-square test for the percentage recording ≥+4; the means of each group were compared using an unpaired t-test. The NPRS with neck rotation, neck and thoracic ROM, and NDI showed significant interactions between the groups. The NPRS with neck rotation was significantly lower in the TSM group than in the sham group at all time points after the treatment (p < 0.001). There was no difference between the groups in the proportion showing moderate (≥+4) improvement according to the GROC; however, there was a significant difference in the mean values (p = 0.013). Incorporating TSM into treatment protocols may improve clinical outcomes in patients with neck pain, potentially leading to better pain management and functional recovery. Therefore, physiotherapists should consider TSM as a viable and effective intervention to improve patient outcomes in neck pain rehabilitation.

Midterm Clinical Outcomes of a Resurfacing Capitate Pyrocarbon Implant: A Case Series

Abstract Purpose Scaphoid nonunion advanced collapse (SNAC), scapholunate advanced collapse (SLAC), and Kienbock's disease are some of the most common pathologies to result in arthritis of the wrist in patients with a relatively high functional demand. An option for treatment where there are not two cartilage surfaces suitable for articulation to allow either a proximal row carpectomy (PRC) or partial fusion is to perform a PRC combined with resurfacing of the capitate using a pyrocarbon implant (RCPI). The purpose of this study was to examine the medium-term survivorship, clinical-, and patient-reported outcomes of the RCPI in a case series of patients. Methods Survivorship was assessed in 46 patients at approximately 21 months or greater (range = 21–144, median follow-up = 67). Of these, 36 patients completed patient-reported outcome measures (Visual Analogue Scales, Disabilities of the Arm, Shoulder and Hand–short form, Patient-Rated Wrist Evaluation, Global Rating of Change) at 21 months or greater. Patient population was 42% (n = 16) female, average age was 59 (range = 25–79), and majority had the operation on their right hand (78%, n = 35). Results Implant survival can be confirmed until most recent follow-up at a median of 60 months (range = 21–144), with Kaplan–Meier analysis indicating an 83% survival probability at 10 years. Complications at 21 months or greater were observed in 11 patients (24%), with 9 (20%) patients receiving further surgery (7 wrist fusions, 1 ulnar nerve decompression, and 1 distal radioulnar joint replacement [RCPI in situ]). Time to revision was a mean of 20 months (range = 4–39). Comparison between passive range of motion at 21 months to 4 years and &gt;5 years showed no significance (p &gt; 0.5), suggesting 2- to 4-year outcomes are maintained midterm. Conclusions The RCPI extends the indications for PRC where there is unsatisfactory cartilage on the proximal capitate, the lunate facet of the radius, or both. It provides a safe and effective treatment for pain relief and improved functional use of the hand for SLAC and SNAC arthritis without the increased morbidity of more complex arthroplasty or total wrist arthrodesis. Level of Evidence IV, case series

A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias.

Alzheimer's disease (AD) is a progressive, multifactorial, neurodegenerative disorder affecting >6 million Americans. Chronic, low-grade neuroinflammation, and insulin resistance may drive AD pathogenesis. We explored the neurophysiological and neuropsychological effects of NE3107, an oral, anti-inflammatory, insulin-sensitizing molecule, in AD. In this phase 2, open-label study, 23 patients with mild cognitive impairment or mild dementia received 20-mg oral NE3107 twice daily for 3 months. Primary endpoints assessed changes from baseline in neurophysiological health and oxidative stress (glutathione level) using advanced neuroimaging analyses. Secondary endpoints evaluated changes from baseline in neuropsychological health using cognitive assessments, including the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment, Clinical Dementia Rating, Quick Dementia Rating Scale, Alzheimer's Disease Composite Score, and Global Rating of Change (GRC). Exploratory endpoints assessed changes from baseline in neuroinflammation biomarkers (tumor necrosis factor alpha, TNF-α) and AD (amyloid beta and phosphorylated tau [P-tau]). NE3107 was associated with clinician-rated improvements in cerebral blood flow and functional connectivity within the brain. In patients with MMSE ≥ 20 (mild cognitive impairment to mild AD; n = 17), NE3107 was associated with directional, but statistically nonsignificant, changes in brain glutathione levels, along with statistically significant improvements in ADAS-Cog11 (P = .017), Clinical Dementia Rating (P = .042), Quick Dementia Rating Scale (P = .002), Alzheimer's Disease Composite Score (P = .0094), and clinician-rated GRC (P < .001), as well as in cerebrospinal fluid P-tau levels (P = .034) and P-tau:amyloid beta 42 ratio (P = .04). Biomarker analyses also demonstrated directional, but statistically non-significant, changes in plasma TNF-α, consistent with the expected mechanism of NE3107. Importantly, we observed a statistically significant correlation (r = 0.59) between improvements in TNF-α levels and ADAS-Cog11 scores (P = .026) in patients with baseline MMSE ≥ 20. Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.