Clinical trials

This study evaluates whether adding mechanical vibration to dry needling (DN+V) is not inferior to dry needling alone (DN) for reducing low back pain intensity in adults with nonspecific low back pain (NSLBP), when both interventions are combined with a structured exercise program. The primary hypothesis is non-inferiority in pain reduction (Numeric Pain Rating Scale, NPRS) at 1 week after treatment, using a non-inferiority margin of 1 point on the 0-10 NPRS scale. If non-inferiority is confirmed, secondary analyses will explore whether DN+V is superior to DN alone in patient-reported treatment acceptability, pain experienced during the intervention, and post-needling soreness. Participants will be randomly assigned to one of two parallel groups: DN plus exercise, or DN+V plus exercise. Outcomes will be assessed at baseline and at multiple time points up to 4 weeks after treatment, including pain intensity, disability, acceptability, muscle strength, pressure pain threshold, quality of life, and global impression of change. Direct and indirect costs associated with both interventions will also be collected to provide data for a future economic evaluation of the cost-effectiveness of DN+V compared with DN.

RIDECLAS is an observational, prospective, non-interventional consensus study using a modified Delphi methodology. The study aims to obtain expert consensus on the classification and final formulation of recommendations for the RICA Pathway, an enhanced recovery pathway for adult surgery. Participants will be healthcare professionals with experience in enhanced recovery, perioperative medicine, surgery, anesthesiology, nursing, rehabilitation, or related disciplines. Experts will complete sequential online questionnaires. Individual responses will remain confidential, and aggregated anonymized feedback will be provided between Delphi rounds. The study does not involve patients, clinical interventions, biological samples, drugs, or medical devices.

Achilles tendinopathy (AT) is one of the most common overuse injuries in runners, with an estimated incidence ranging from 0.6% to 18.5% of all running-related injuries, reaching up to 52% in elite runners. Its prevalence increases significantly from the fourth decade of life due to histological changes associated with aging, such as tissue degeneration, decreased vascularization, alterations in collagen structure, reduced recovery capacity, and increased tendon stiffness. The repetitive nature of running and the high proportion of the population practicing this sport make runners, especially those over 40 years old, a particularly vulnerable group. The etiology of AT is multifactorial and includes biomechanical, physiological, and contextual factors. Major risk factors include sudden increases in load, planning errors in training, biomechanical alterations, overweight, metabolic comorbidities such as diabetes or dyslipidemia, and exposure to certain medications, especially corticosteroids and fluoroquinolones. In middle-aged individuals, the combination of intrinsic and extrinsic factors along with structural tendon changes explains both the higher prevalence and the worse prognosis observed in this population. Physiotherapy is one of the preferred treatments for AT, with therapeutic exercise-particularly the Alfredson protocol-being the intervention with the strongest scientific support. Despite its efficacy, between 25% and 45% of patients do not achieve full recovery, suggesting the influence of clinical, personal, and contextual factors not always considered in studies. Additionally, there is high variability in return-to-sport times, which has led to the development of specific programs for runners over 40. In the Aragón community, there are no studies describing the extent of AT in senior runners nor systematically analyzing their clinical characteristics, comorbidities, referral patterns, or healthcare service use. This lack of information hampers evidence-based decision-making and the planning of preventive and therapeutic strategies in physiotherapy. This study aims to fill this gap by providing contextualized information to improve clinical practice, healthcare pathways, and physiotherapeutic guidelines. The hypothesis of the study is that an assessment system using screening has validity for detecting clinical changes in senior runners with Achilles tendon pain. The main objective is to determine the validity of this screening compared to other clinical measures after applying a physiotherapy protocol. A clinimetric validity design is proposed. The sample will include 40 runners over 40 years old, belonging to sports clubs, who train at least three days a week and have participated in at least five 10 km races in the past year. Participants will be recruited through running clubs and social media, and randomly assigned to two groups of 20 people each. Exclusion criteria include recent invasive treatments, use of fluoroquinolones in the last year, autoimmune diseases, or difficulties understanding questionnaires. Data collected will include sociodemographic, anthropometric, sports activity, and clinical variables through validated scales (VISA-A, NPRS, IPAQ, and SMFA), as well as ultrasound characteristics of the tendon, ankle mobility, passive calcaneal mobility, and functional screening tests based on active movements and jumps. The procedure involves initial measurements, random assignment to control or experimental groups, and a 12-week home self-treatment program. Both groups will perform the Alfredson exercise protocol and receive health education; the experimental group will add analytical stretching of the posterior chain following OMT methodology. Statistical analysis will assess intergroup and intragroup differences using repeated measures ANOVA, analyze time-group interactions, and include sensitivity-to-change statistics such as effect size, minimal clinically important difference, and reliable change index. A gender perspective will be incorporated, limiting the representation of one sex to a maximum of 70% of the sample and analyzing results separately by gender. Main limitations include the small sample size, short follow-up duration, and limited control over adherence to home treatment. Finally, the study clearly defines internal and external validity and clarifies the use of the term screening as a functional discrimination tool within a homogeneous and clinically defined population, without asserting generalization to the broader population.

This study explicitly tests a multisensory virtual reality experience that combines visual, auditory, and olfactory channels to modulate the stress response in young adults. In addition to visual and auditory stimulation, the study also assesses whether a relaxing olfactory stimulus attenuates this effect. The environment and task remain constant (constant visuals); auditory and olfactory elements are varied. Objective. To evaluate the main effects of varying auditory and olfactory stimuli, as well as their interaction, on variables related to the performance of a quiz-type task in virtual reality.

This study evaluates the MenTOras program, a structured peer mentorship intervention designed for newly graduated occupational therapists in Aragón, Spain. The transition from university to professional practice can be challenging, and many new occupational therapists face isolation, limited guidance, and uncertainty about their professional role. The MenTOras program connects newly graduated occupational therapists (mentees) with more experienced colleagues (mentors). Over a three-month period, mentor-mentee pairs participate in at least six structured sessions, either online or in person. These sessions are designed to support professional integration, strengthen self-confidence, promote reflective practice, and provide emotional support. The study uses a mixed-methods approach. Quantitative data are collected before the program, after completion, and six months later to assess perceived professional integration, emotional well-being, and professional confidence. In addition, qualitative interviews with a subset of participants explore their experiences in greater depth. By fostering peer support, MenTOras aims to improve the early career experience of occupational therapists and provide a model for sustainable mentoring practices within the profession.

Hamstring injuries are among the most prevalent and troublesome injuries in athletes, particularly those engaged in sports that require high-speed movements such as sprinting, kicking, and rapid changes in direction. The hamstring muscles, which include the biceps femoris, semitendinosus, and semimembranosus, are essential for powerful lower limb actions, and thus, any injury to these muscles can significantly impact an athlete's performance and recovery. These injuries often occur during eccentric muscle contractions, such as when the muscles lengthen rapidly under tension, as seen in running and sprinting. According to epidemiological studies, hamstring strains account for a substantial portion of sports-related injuries, with hamstring strains being the most commonly reported injury in disciplines such as football, soccer, rugby, and athletics. In professional football, for instance, hamstring injuries account for approximately 12% of all injuries and represent the most frequent muscle strain, underlining their significance in the context of athletic performance.

This study presents the protocol for a non-randomized controlled trial evaluating a motivational-based training program for pre-service Physical Education teachers. The experimental group will participate in a 14-hour training program based on Self-Determination Theory and the circumplex model. The program consists of theoretical and practical training to foster motivating teaching styles and minimize demotivating ones. The control group will follow the standard curriculum of the Master's in Physical Education Teacher Education program without exposure to the specific intervention.

Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing.

The aim of the study is to evaluate, at the level of global cognition, cognitive neuroconstructs, memory, verbal fluency, ADLs, IADLs, symptoms of depression and anxiety, the effectiveness of a personalised and adapted computerised cognitive stimulation programme (GI1) implemented from Primary Care versus stimulating leisure activities (GI2), in older adults aged 50 years and over with mild cognitive impairment and subjective cognitive impairment living in the community.