Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial.

STUDY DESIGN: This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design. OBJECTIVE: To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin. SETTING: The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital. METHODS: Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests. RESULTS: Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline. CONCLUSION: Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry.Trial registration: Clinical Trials Registry India identifier: CTRI/2018/05/013735.

A cross-sectional study to assess dual-task interference in postural control in people with lower limb amputation.

BACKGROUND: In people with lower limb amputation (LLA), the loss of limb structures and peripheral motor and sensory systems result in significant mobility challenges, including impaired postural stability. OBJECTIVE: The primary objective of this study was to evaluate the dual-task interference (DTI) on postural control and dual-task interference on cognition during static and dynamic balance in people with LLA and compare the same with controls. The secondary objective of this study was to compare the DTI on postural control and DTI on cognition between LLA of different etiology. DESIGN: Cross-sectional observational study METHODOLOGY: Fifteen people with unilateral LLA and 15 age and gender-matched controls participated in this study at a tertiary care hospital. The outcome measures used were anterior-posterior stability index (APSI), medial-lateral stability index, and overall stability index (OSI) using Biodex Balance System and a cognitive task parameter, namely correct response rate in serial seven subtraction test. Quantitative variables were compared using a Wilcoxon rank-sum test. Spearman's correlation test was used to establish the correlation between the DTI on cognition and the DTI on postural control. RESULTS: DTI on postural control during static balance was significantly higher in people with LLA than controls (APSI, OSI). No significant difference was observed in DTI on postural control during dynamic balance. No significant difference was observed in DTI on cognition during static and dynamic balance. A significant negative correlation was observed between DTI on cognition and DTI on postural control (APSI) during static balance people with LLA. SIGNIFICANCE: In people with unilateral LLA, the addition of a cognitive task results in significant deterioration of sagittal plane postural control during static balance but not during dynamic balance due to the over-allocation of resources to a cognitive task.

Efficacy of exercises in early-stage Parkinson's disease (PARK-EASE trial): single-blind, randomised, controlled trial.

Objectives: To assess the efficacy of exercises in early-stage Parkinson's disease (PD). Design: Single-blind, randomised controlled trial. Setting: Tertiary rehabilitation care centre. Participants: Forty individuals (≥18 years, either gender) with newly diagnosed PD (Hoehn and Yahr stage ≤2) on a stable dose of PD medications were randomised (1:1) to the intervention group (IG) and control group (CG). Interventions: The IG received strengthening (30 min/day, 2 days/week), aerobic (30 min/day, 3 days/week) and agility (30 min/day, 2 days/week) exercises in a structured format for 12 weeks. CG received stretching exercises for 12 weeks. Main outcome measures: Unified PD Rating Scale (UPDRS) III (motor) at week 12 (primary), UPDRS I (mentation, behaviour and mood), UPDRS II and VI (Schwab and England Activities of daily living Scale) and Parkinson's Disease Quality of Life (PDQL) at week 12 (secondary). Results: 36 participants completed 12-week study period. UPDRS III (lesser scores reflect improvement) at 12 weeks showed a significant between-group difference (-5.05 points (95% CI: -9.38 to -0.71), p=0.02). At 4 and 8 weeks, UPDRS III did not show a statistically significant between-group difference (-2.15 points (95% CI: -6.77 to 2.47) and -4.1 points (95% CI: -8.54 to 0.34), respectively). From baseline to 12 weeks, UPDRS III in the IG showed a 6.5-point (95% CI (4.85 to 8.14)) reduction, and the CG showed a 0.8-point increase (95% CI (-3.06 to 1.46)), PDQL (higher scores reflect improvement) in the IG showed a 8.45-point (95% CI (-12.78 to -4.11)) increase and CG showed a 2.75-point (95% CI (0.16 to 5.33)) reduction. Conclusions: Structured exercises improve motor symptoms and quality of life in early-stage PD. Consistent adherence for at least 12 weeks is crucial for clinical improvement. Early initiation of exercises as neurorehabilitation is recommended. Further research on specific types, dosing and intensity of exercises with a larger sample size is warranted in early-stage PD. Trial registration number: CTRI/2018/05/014241.

Effect of Motor Imagery on Corticomotor Excitability and Pain Status in Rheumatoid Arthritis Patients.

OBJECTIVES: Rheumatoid arthritis (RA) has been defined by the American College of Rheumatology in 1987 as a chronic inflammatory disease characterised by joint swelling, joint tenderness, and destruction of synovial joints leading to severe disability and premature mortality. There is a paucity of literature assessing corticomotor excitability in RA patients. This study aimed to assess the effect of motor imagery on corticomotor excitability and pain status in RA patients. The specific objectives were to study the effect of motor imagery on corticomotor excitability and pain status in RA patients. We also wanted to compare the corticomotor excitability between RA patients with healthy controls. The correlation between the measures of corticomotor excitability and pain status in RA patients has also been done. METHODS: The study was designed as a pilot clinical trial with a case-control design. Forty participants were recruited for the study. Twenty RA patients were recruited from the Department of Rheumatology and Department of Physical Medicine and Rehabilitation (PMR), AIIMS, New Delhi, and 20 healthy controls. Testing was performed at the Pain Research & rTMS Lab, Department of Physiology, AIIMS, New Delhi. The study was approved by the Institute Ethics Committee, AIIMS New Delhi, and registered in the Clinical Trials Registry-India (CTRI). For the subjective assessment of pain, the visual analogue scale (VAS), Short-Form McGill Pain Questionnaire, WHO-Quality of Life Brief questionnaire (WHO-QOL-BREF), and Rheumatoid Arthritis Pain Scale were used. For the objective assessment of pain, hot and cold pain thresholds were assessed using thermo-tactile quantitative sensory testing (QST) using the method of limits and corticomotor excitability using a transcranial magnetic stimulation device. All participants were also asked to perform motor imagery tasks which consisted of a metronome-paced thumb opposition paradigm.  Results: The resting motor threshold (RMT) decreased significantly after motor imagery when compared to the mental calculation group. The amplitude of motor evoked potential (MEP) and QST parameter value was comparable in both the groups before and after motor imagery and mental calculation. RMT was found to be significantly higher whereas MEP values were found to be significantly lower in RA compared to controls. CONCLUSION: We conclude that patients suffering from RA have decreased corticomotor excitability compared to controls. Motor imagery was effective in improving corticomotor excitability in these patients and can be used as rehabilitation in RA to relieve their pain.

Effectiveness of Telerehabilitation in Persons With Spinal Cord Injury During the COVID-19 Pandemic (TELE-SCOPE): A Single-Center, Double-Blind, Randomized Controlled Trial.

Introduction The COVID-19 pandemic has posed numerous challenges in accessing adequate healthcare services, particularly for individuals with spinal cord injury (SCI). On the other hand, telerehabilitation has emerged as a promising solution to address healthcare needs. Since there was no study during the pandemic, we started this study with the aim of assessing the efficacy of telerehabilitation for individuals with SCI during the COVID-19 pandemic. Methods This is a prospective double-blind, randomized, controlled trial conducted in a tertiary rehabilitation care center hospital. Thirty participants with traumatic spinal cord injuries (age 18 years or more, either gender) were equally randomized to the telerehabilitation or control group (1:1). Biweekly telerehabilitation sessions (each session: 30 minutes) were provided. Participants in the control group were advised to continue standard usual care as advised previously during outpatient or inpatient rehabilitation. The Spinal Cord Independence Measure (SCIM III) (primary outcome measure) and Coronavirus Anxiety Scale (CAS) (secondary outcome measure) were evaluated at baseline, four weeks, and eight weeks. Results The mean age of the intervention group was 28.2±6.9 years, and the mean age of the control group was 26.3±7.7 years. The self-care (P = 0.03) and mobility domains (P=0.01) of the SCIM III in the intervention group compared to the control group, as determined through a between-group analysis, showed statistically significant differences. CAS also showed improvement in the intervention group compared to the control group. Within-group analysis showed a mean difference of 6.3 points in the intervention group compared to the control group (1.3 points). Conclusion Telerehabilitation intervention is safe, feasible, and effective in improving self-care and mobility domains in persons with spinal cord injuries during the pandemic. It is also effective in reducing the anxiety related to the coronavirus in this population. Further research with a larger sample size and a longer duration is needed to evaluate long-term effectiveness during such crises.

A Dysfunctional Descending Pain Modulation System in Chronic Nonspecific Low Back Pain: A Systematic Review and ALE Meta-Analysis.

Pain, a physiological protective mechanism, turns into a complex dynamic neural response when it becomes chronic. The role of neuroplastic brain changes is more evident than the peripheral factors in the maintenance, modulation and amplification of chronic low back pain (cLBP). In this background, we summarise the brain changes in cLBP in a coordinate-based activation likelihood estimation (ALE) meta-analysis of previous functional magnetic resonance imaging (fMRI) studies. Databases ('PubMed', 'Scopus' and 'Sleuth') were searched till May 2022 and the activity pattern was noted under the 'without stimulation' and 'with stimulation' groups. A total of 312 studies were selected after removing duplicates. Seventeen (553 cLBP patients, 192 activation foci) studies were fulfilled the eligibility criteria and included in the 'without stimulation' group. Twelve statistically significant clusters are localized in the prefrontal cortex, primary somatosensory cortex, primary motor cortex, parietal cortex, anterior cingulate cortex, caudate, putamen, globus pallidus amygdala, occipital lobe, temporal lobe and associated white matter in this group. Ten studies (353 cLBP patients, 125 activation foci) were selected in the' with stimulation' groups. In this group, seven statistically significant clusters were found in the frontal cortex, orbitofrontal cortex, premotor cortex, parietal cortex, claustrum and insula. These statistically significant clusters indicate a probable imbalance in GABAergic modulation of brain circuits and dysfunction in the descending pain modulation system. This disparity in the pain neuro-matrix is the source of spontaneous and persisting pain in cLBP.

"Platelet-Rich Fibrin Membrane-as a novel biomaterial for pressure injury healing in a person with spinal cord injury: A case report".

INTRODUCTION: Pressure injury (PI) impacts the quality of life, and socioeconomic and psychological well-being negatively in persons with Spinal Cord Injury (SCI). Autologous Platelet Rich Plasma (PRP) and Platelet Rich Fibrin (PRF) showed promising roles in wound healing. PRF is considered a second-generation PRP, contains more growth factors and is more biocompatible than PRP. It possesses an additional favourable impact on wound healing due to its three-dimensional fibrin architecture, and antimicrobial property. There are no studies on PRF membrane use for PI healing in SCI. CASE PRESENTATION: A 25-year-old male with operated traumatic T10 American Spinal Injury Association Impairment Scale grade A paraplegia with neurogenic bowel, and bladder and a stage II PI over the left greater trochanter, was admitted for inpatient rehabilitation. The chronic non-healing PI which did not show any improvement following normal saline (0.9%) dressing for the past 3 months, was treated with autologous PRF membrane weekly for four weeks. The PI healed completely and no adverse events were noted. Weekly total scores of the Spinal Cord Impairment Pressure Ulcer Monitoring Tool and Pressure Ulcer Scale for Healing were 6, 6, 5, 2, 0 and 12, 10, 10, 3, and 0 respectively. DISCUSSION: To the best of our knowledge, this is the first case report on the healing of PI in SCI with the use of PRF. This novel biomaterial is a safe and effective promising agent for PI management in SCI. But further randomized trials are needed to establish stronger evidence regarding feasibility and effectiveness.

Executive Summary of Evidence and Consensus-Based Clinical Practice Guidelines for Management of Obesity and Overweight in Midlife Women: An AIIMS-DST Initiative.

Weight gain is an independent risk factor for decline in cardiometabolic and overall health-related quality of life in midlife women. The AIIMS-DST initiative aims to develop and validate stepwise recommendations specific for weight management in midlife women. The key clinical questions specific to weight management in midlife women were finalized with the help of a multidisciplinary team of experts in the guideline development group. Phase I including a systematic and/or narrative review, grading of evidence, and expert opinion was sought to develop clinical practice recommendations for each clinical question. Phase II focused on validation of clinical practice recommendations using the peer-review, Delphi method, and GRADE approach. The guidelines provide clinical practice points to address challenges encountered by midlife women in their attempts to manage obesity via lifestyle modification techniques. The initiation of discussion would help the health-care provider to identify the weight management needs of the women, educate women on different modalities of weight management, and empower them to incorporate corrective lifestyle behaviors. Before initiating the management, a comprehensive assessment of clinical and lifestyle-related parameters should be completed. A personalized behavioral lifestyle modification program addressing the midlife-specific barriers for optimal metabolic, musculoskeletal, and mental health should be planned. A consistent follow-up is required for maintenance of corrective eating and activity habits by addressing midlife-specific barriers for sustenance of healthy weight. These recommendations will be useful in opportunistic screening and management of obesity in midlife women across health-care settings.

Physical Activity, Yoga, and Exercise Prescription for Postpartum and Midlife Weight Management: A Practical Review for Clinicians.

This narrative review is aimed to practically review and evaluate the existing evidence and illuminate the effectiveness of physical activity, yoga, and exercise for postpartum and midlife weight management. A comprehensive review was conducted using electronic databases such as PubMed and google scholar using search terms physical activity, exercise, yoga, postpartum, midlife, weight loss, weight reduction, and all the probable terms. This helped in generating evidence-based information and formulating practical physical activity prescriptions to be used by obstetricians, general clinicians, nutritionists, and other allied healthcare personnel. Overweight and obesity in postpartum and midlife women present long-term health risks and complications. Indulging in optimum physical activity comprising exercise and yoga will help in weight management, increasing muscular strength, and endurance thus improving overall health and well-being. Supplementary Information: The online version contains supplementary material available at 10.1007/s13224-022-01627-w.

Executive summary of evidence and consensus-based clinical practice guideline for management of obesity and overweight in postpartum women: An AIIMS-DST initiative.

INTRODUCTION: Postpartum obesity is a public health concern. There is a need to counsel women about their postpartum weight management, accounting for various barriers they face. Limited literature in the Indian context underscored the need to develop the clinical practice guideline to be used by healthcare providers in Indian healthcare settings. METHODS: The guideline was formulated by following the standardised methodology proposed by the National Health and Medical Research Council. Various steps such as identification of the patient population, assembly of the guideline development groups, identification of the key clinical questions, guideline development methods, grading the quality of evidence and recommendations and guideline translation were carried out to develop and validate the clinical practice recommendations. RESULTS: The evidence and consensus-based clinical practice guideline has been developed, providing recommendations for key topics of interest for first-line treatment of obesity (lifestyle-related management). Recommendations focus on screening and initiating discussion with overweight and obese postpartum women as well as those who had normal pre-pregnancy body mass index but have retained excessive weight in the postpartum period. Recommendations highlight the evaluation and management of dietary, physical activity and breastfeeding behaviour. Recommendations also account for behavioural modification techniques to improve adherence to the prescribed weight management advice. Duration and frequency of follow-ups as well as the advice to be disseminated have also been discussed in the recommendations. CONCLUSION: The guideline provides clinical practice points that can be used by healthcare providers, postpartum women and policymakers for opportunistic screening and management of postpartum obesity.

Executive summary of evidence and consensus-based Clinical Practice Guidelines for management of obesity and overweight in midlife women: An AIIMS-DST initiative.

BACKGROUND AND AIMS: Weight gain is an independent risk factor for decline in cardiometabolic and overall health-related quality of life in midlife women. The AIIMS-DST initiative aims to develop and validate stepwise recommendations specific for weight management in midlife women. METHODS: The key clinical questions specific to weight management in midlife women were finalised with the help of a multidisciplinary team of experts in the guideline development group (GDG). Phase I included a systematic and/or narrative review to gather evidence, grading of evidence and expert opinion was sought to develop clinical practice recommendations for each clinical question. Phase II focused on validation of clinical practice recommendations using the peer-review, Delphi method and GRADE approach. RESULTS: -The guidelines provide clinical practice points to address challenges encountered by midlife women in their attempts to manage obesity via lifestyle modification techniques. The initiation of discussion would help the healthcare provider to identify the weight management needs of the women, educate women on different modalities of weight management, and empower them to incorporate corrective lifestyle behaviours. Before initiating the management, a comprehensive assessment of clinical and lifestylerelated parameters should be completed. A personalised behavioural lifestyle modification program addressing the midlife specific barriers for optimal metabolic, musculoskeletal, and mental health should be planned. A consistent follow-up is required for maintenance of corrective eating and activity habits by addressing midlife specific barriers for sustenance of healthy weight. CONCLUSION: These recommendations will be useful in opportunistic screening and management of obesity in midlife women across healthcare settings.

Objective evidence for chronic back pain relief by Medical Yoga therapy.

Chronic low back pain (CLBP) is a musculoskeletal ailment that affects millions globally. The pain is disturbing associated with impaired motor activity, reduced flexibility, decreased productivity and strained interpersonal relationships leading to poor quality of life. Inflammatory mediators in vicinity of nociceptors and amplification of neural signals cause peripheral and central sensitization presented as hyperalgesia and/or allodynia. It could be attributed to either diminished descending pain inhibition or exaggerated ascending pain facilitation. Objective measurement of pain is crucial for diagnosis and management. Nociceptive flexion reflex is a reliable and objective tool for measurement of a subject's pain experience. Medical Yoga Therapy (MYT) has proven to relieve chronic pain, but objective evidence-based assessment of its effects is still lacking. We objectively assessed effect of MYT on pain and quality of life in CLBP patients. We recorded VAS (Visual analogue scale), McGill Pain questionnaire and WHOQOL BREF questionnaire scores, NFR response and Diffuse noxious inhibitory control tests. Medical yoga therapy consisted of an 8-week program (4 weeks supervised and 4 weeks at home practice). CLBP patients (42.5 ± 12.6 years) were randomly allocated to MYT (n = 58) and SCT groups (n = 50), and comparisons between the groups and within the groups were done at baseline and at end of 4 and 8 weeks of both interventions. (VAS) scores for patients in both the groups were comparable at baseline, subjective pain rating decreased significantly more after MYT compared to SCT (p = < 0.0001*, p = 0.005*). McGill Pain questionnaire scores revealed significant reduction in pain experience in MYT group compared to SCT. Nociceptive Flexion Reflex threshold increased significantly in MYT group at end of 4 weeks and 8 weeks, p < 0.0001#, p = < 0.0001∞ respectively) whereas for SCT we did not find any significant change in NFR thresholds. DNIC assessed by CPT also showed significant improvement in descending pain modulation after MYT compared to SCT both at end of 4 and 8 weeks. Quality of life also improved significantly more after MYT. Thus, we conclude with objective evidence that Medical Yoga Therapy relieves chronic low back pain, stress and improves quality of life better than standard care.

Comparing Effectiveness of Combination of Collagen Peptide Type-1, Low Molecular Weight Chondroitin Sulphate, Sodium Hyaluronate, and Vitamin-C Versus Oral Diclofenac Sodium in Achilles Tendinopathy: A Prospective Randomized Control Trial.

Background Achilles tendinopathy, a common cause of heel pain, is primarily considered mechanical in origin, but its pathogenesis and treatment lack consensus. Molecules such as collagen peptide type-1, low molecular weight chondroitin sulphate, sodium hyaluronate and vitamin C have been shown to act as building blocks of tendon structure, and oral supplementation of these have promising results in Achilles tendinopathy. Methods This study was a prospective randomized control trial to compare the effectiveness of oral diclofenac sodium versus a nutraceutical combination of collagen peptide type-1, chondroitin sulphate, sodium hyaluronate, and vitamin C in the treatment of Achilles tendinopathy on pain and ultrasonographic structures. A total of 40 patients satisfying inclusion and exclusion criteria were randomly allocated into two groups and were given the nutraceutical combination in group A and diclofenac sodium in group B. The patient evaluation was done at baseline, six-week, and 12-week intervals in terms of VAS (Visual Analogue Scale) and tendo-Achilles thickness by ultrasound. Results Both nutraceutical combination and diclofenac reduced pain in persons with Achilles tendinopathy. The nutraceutical combination had a statistically significant better outcome in reducing pain at the end of 12 weeks. On ultrasound, both the interventions reduced Achilles tendon anteroposterior and mediolateral thickness by the end of 12 weeks. Although there was no absolute significant intergroup difference, the percentage change was more in the nutraceutical group in the case of anteroposterior thickness. Conclusion Combining collagen peptide type-1, low molecular weight chondroitin sulphate, sodium hyaluronate, and vitamin C is more effective than oral diclofenac in controlling pain in Achilles tendinopathy.

A Cross-Sectional Study on Central Sensitization and Autonomic Changes in Fibromyalgia.

Fibromyalgia is a multi-symptomatic disorder characterized by generalized pain. The pathophysiology of fibromyalgia is supposedly an interplay between central nervous system hyper-responsiveness, autonomic dysfunction, and peripheral pain. In this cross-sectional study, the objective was to assess central sensitization and autonomic activity in patients with fibromyalgia compared with control. Fifty adults diagnosed with fibromyalgia by the modified American College of Rheumatology 2010 criteria and an equal number of age- and sex-matched controls participated in the study in an urban tertiary care hospital. Central sensitization was assessed by history and by evidence of increased prefrontal cortical activity as measured by cortical oxygenation using functional near-infrared spectroscopy. Autonomic activity was assessed by heart rate variability, electrodermal activity, and deep breathing test in three physiological states: rest, sympathetic stress (cold pressor test), and deep breathing. Mann-Whitney U-test, paired t-test, Wilcoxon test, and Friedman test with Bonferroni a priori were used to analyze the data. Cortical activity was significantly higher in the fibromyalgia group than control. There was no significant difference in autonomic activity between the fibromyalgia and control groups. In the fibromyalgia group, variable degrees of sympathetic hyperactivity and normal parasympathetic activity were observed. Central sensitization may be playing a primary role in the pathophysiology of generalized pain in fibromyalgia.