Active clinical trials for "Musculoskeletal Pain"

The proposed study will test the feasibility and acceptability of an 8-week home-based reciprocal peer support pain self-management intervention (CONNECT) for women Veterans with chronic musculoskeletal pain. The use of this format will improve the accessibility of treatment to women Veterans who experience logistical, healthcare delivery and psychosocial barriers to care. To address these barriers women Veterans who enroll in CONNECT will be paired and work together to learn/practice pain coping skills, set meaningful activity goals, and participate in a graduated walking program; they will exchange nightly text messages and engage in a weekly 20 minute phone call to reinforce each other and provide support for pain self-management efforts. This is a single-arm pilot project; all eligible and interested women with chronic musculoskeletal pain will receive CONNECT. The primary outcome will be post-treatment and long-term follow-up retention rates.

Treatment options for chronic non-oncologic musculoskeletal pain are varied and include both pharmacological and non-pharmacological interventions, such as physical activity and psychotherapy. In clinical practice, the prevalent approach is pharmacological, based mainly on the use of pain modulators, such as antidepressants, cannabinoids and anti-epileptics, and on the use of traditional painkillers such as NSAIDs and opioids. In particular, the latter are still widely prescribed in clinical practice. Initially very effective in combating fibromyalgia pain, opioids, when taken chronically, lead to the development of tolerance with the need for the patient to gradually increase the dosage or switch to more powerful active drugs to obtain the same effect. In the face of fleeting and limited benefits, the risk, therefore, is that of falling back into a framework of abuse with consequent negative impact on both health and social status. In this context, the non-pharmacological approach plays a role of primary importance. In particular, exercise is currently recommended as one of the most effective management strategies. However, the implementation of exercise as a treatment for chronic pain is significantly hampered by poor patient compliance. Another non-pharmacological strategy is biofeedback (BF); however, although existing data support the use of BF, in clinical practice the results obtained have not supported expectations. A solution to these limitations could come from virtual reality (VR), an innovative method capable of simulating real-world situations and cognitive and motor tasks in a safe and stimulating environment, making the completion of activities rewarding and benefiting all those patients who need motor rehabilitation or musculoskeletal pain management. This is a single-center interventional randomized device-controlled study, with two study arms: The treatment group: subjected to 5 days of VR experience and subsequently monitored using questionnaires until the 15th day after the end of the experience. The control group: initially placed on hold and subsequently also subjected to 5 days of VR experience only when the treatment group has finished its shift; subsequently each patient will be monitored until the 15th day after the end of the experience. Primary endpoint: - Demonstration of a pain reduction of at least 30% according to the VAS scale (0-100) in patients undergoing VR compared to those not undergoing VR. Inclusion criteria - Patients aged 30-50 years who complain of chronic musculoskeletal pain lasting at least three months, without diagnosis of inflammatory causes Exclusion criteria Concomitant diagnosis of major psychiatric pathologies with the exception of anxiety-depressive disorder; Concomitant diagnosis of neurological pathologies; Concomitant diagnosis of inflammatory rheumatological diseases that may cause chronic pain. Statistical analysis On the basis of the primary endpoints set, it is planned to enroll a sample of 20 patients, 10 per treatment group, considering an alpha error of 0.05 and a power of 80%. Considering a dropout of approximately 2 patients, a final sample of 24 patients is considered, 12 for each group. Comparisons between the two groups of patients will be performed using parametric or non-parametric statistical tests, based on the distribution of the variables, using the Student or Mann-Whitney t test for continuous variables, and Chi-square or Fischer, for variable dichotomous or ordinal. Any correlations will be determined through the calculation of the Odds Ratio.

A randomized control trial will be conducted, for evaluating the effectiveness of the implementation of a lower back assistive exoskeleton on the caregivers working in nursing homes.

The main objective of this study is to determine whether the administration of a single dose of Vitamin D in the Emergency Department following a motor vehicle collision can improve musculoskeletal pain severity as well as reduce musculoskeletal pain outcome disparity between Blacks and White following a motor vehicle collision. This randomized controlled trial is a pilot study to determine feasibility and potential efficacy (response to study drug, ability to reduce racial disparity in pain outcomes). This data can be used to adequately power a larger randomized controlled trial to fully assess efficacy.

Nearly 2 out of 10 women will sustain a distal forearm fracture throughout their lifespan.Recent longitudinal studies illustrate that as many as 1/3 of all persons who undergo closed reduction and casting for distal radius fractures (DRF) go on to develop type 1 complex regional pain syndrome (CRPS). Graded motor imagery (i.e., motor imagery and mirror therapy), a movement representation technique, is strongly supported in the literature as a treatment of CRPS and has recently been suggested as a potential strategy to prevent its onset. Other complications include disability, wrist/forearm tightness and sensorimotor changes. The investigators propose that an early intervention protocol which includes graded motor imagery (GMI) will improve the pain, functional and upper limb sensorimotor outcomes of persons following closed reduction and casting of DRF relative to a standard of care intervention.

The study design is a 2-arm randomized controlled trial with 6-month intervention period and follow-up at 6, 12 and 24 months among blue-color workers of Nokia City with reduced work ability and high number of musculoskeletal problems. The participants (n=190) will be randomly assigned to intervention-arm providing face-to-face Personalized Exercise Counseling combined with interactive accelerometer (PEC-arm) or a non-intervention Control-arm. The study aims at improving workability (main outcome) and reducing musculoskeletal pain by counseling and motivating the workers to increase physical activity and exercise according to self-selected modes. Exercise instructors of Nokia City are responsible for providing the face-to-face part of PEC. The Urho Kaleva Kekkonen (UKK) Institute is responsible for providing online feedback of the data collected by the interactive ExSed® accelerometer, stored and analyzed in the Cloud, from where the participants in the PEC-arm receive daily feedback thru a smart phone application. Cost-effectiveness of the PEC-intervention compared to the Control-arm in terms of quality adjusted life-years (QALY) and days of sickness absence are also investigated. The following measurements will be taken at baseline and the three follow-up timepoints: work-, health- and physical activity related factors collected by two electronic questionnaires, objective measurements of movement continuum (sleep, sedentary behavior, standing-ups, standing, light activity, moderate activity, vigorous activity) for 24/7 (RM42 research accelerometer), 3 tests of physical fitness and blood samples related to blood sugar and lipid profile.

Chronic neck pain is a common problem among the general population. Patients with chronic neck pain used health care services twice as much as the population on average, mainly due to intense pain intensity. It is well-known that pain intensity depends on the association of pain processing in several levels of central pain processing. Identifying the association between conditioned pain modulation, temporal summation, and somatosensory representation, all represent separate central pain processing, will provide an opportunity to develop treatment strategies.

Self-care and self-medication are commonly the treatments of choice for the management of minor ailments. Minor ailments can be treated through community pharmacy using a Minor Ailment Service (MAS). The INDICA+PRO Impact Study, evaluated the clinical, economic and humanistic impact of a MAS, concluding that community pharmacies could greatly benefit the health system. Thus, the following objectives were defined for the INDICA+PRO implementation study. The primary objective is to implement a standardised MAS in usual practice in community pharmacy in Spain. The secondary objectives include an evaluation of the clinical and economic outcomes and the role and impact of two different models of change agents. A pragmatic study with an effectiveness-implementation hybrid design type 3 will be undertaken using the Framework for the Implementation of Services in Pharmacy (FISpH). The study will be carried between October 2020 and December 2022. Two type of practice change facilitators FaFa and SEFaFa. Their main function, using the Observe-Plan-Do-Study-Act process, will be to facilitate the implementation through individualised continuous support to providers of the MAS. The depth and breadth of support to pharmacist providers by each type of change agents will vary. Pharmaceutical Associations (PA) and/or Spanish Society of Community Pharmacy (SEFAC) will invite community pharmacies/pharmacists. Participating pharmacists will need to sign a commitment form. The second study population will consist of patients presenting with minor ailments or requesting a non-prescription medication. Recruitment of patients will be carried out by the pharmacist providers. The inclusion criteria will be: patients or caregivers (aged ≥18 years, or younger if they are accompanied by an adult) presenting with 31 minor ailments, grouped into five categories (respiratory, moderate pain, digestive, dermatological and other) with pre-agreed referral protocols. Other symptoms may be included at the discretion of the pharmacists. The exclusion criteria will be patients who do not provide informed consent. The patient/pharmacist intervention will consist of a MAS protocol adapted for each symptom. The consultation will be record in an electronic data capture system (SEFAC eXPERT®-) that provides a step-by-step approach with protocols and clinical information embedded. The FISpH model will be used to guide the implementation of MAS. Two types of change agents, FaFas and SeFaFas, previously trained for 18 hours, will be used to facilitate the implementation. During each of the stages (exploration, preparation, testing and operation, and initial sustainability), strategies will be used by FaFas and SeFaFas to moderate implementation factors. The impact of strategies will be evaluated. Data on pharmacy/pharmacist's provider performance and patient outcomes will be provided to pharmacist, change agents and PA and SEFAC. FaFas and SeFaFas will have a classification system for barriers and facilitators derived from the constructs in the Consolidated Framework for Implementation Research (CFIR). The classification system for implementation strategies consists of an adaptation of the facilitation activities listed by Dogherty et al. These will be documented in an electronic data capture system. FaFas will train their pharmacists (max. of 25 pharmacies) for 6 hours and subsequently provide at least monthly follow-up. The research team will provide ongoing feedback and support to the FaFas and SeFaFas through periodically, hold group meetings by video conference between the research group and all the FaFas and SeFaFas. The research group will provide formal reports on the implementation process and patient outcomes. Other forms of communication such as emails, telephone calls or WhatsApp messaging will also be available. Implementation and patient consultation process and outcome variables will be measured such as reach, fidelity and integration. Outcome service indicators will be clinical, economic and humanistic. A patient follow up will occur at a maximum of 10 days. Continuous variables will be reported using mean and standard deviation, or median and percentiles. Categorical variables will be reported using percentages. T Student's test or the ANOVA test or Kruskal-Wallis. χ2 test, Fisher's exact test or Yate's chi-squared will also be used. To determine the relationship between the dependent and the independent variables, logistic regression models will be performed including the variables with statistical significance in the bivariate model. The level of significance will be set at p <0.05. Machine learning and big data techniques are being considered for predictive modelling. The research team will only have access to de-identified data of pharmacists and patients. This study protocol has been approved by the Granada Research Ethics Committee on the 5th February 2020.

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are: Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain? What are predictors of recovery from chronic pain? What brain systems are associated with the spread of pain? For this study participants will undergo: Functional Magnetic Resonance Imaging (fMRI) Quantitative Sensory Testing Psychological Assessments