Clinical Research Directory

Ultrasound-guided Percutaneous Electrical Stimulation for Gluteus Muscle Dysfunction After Low Back Pain Episode

Percutaneous ultrasound-guided neuromodulation (US-guided PNM) is the electrical stimulation of a peripheral nerve at some point along its pathway or at a muscular motor point under the guidance of an ultrasound probe with a therapeutic objective. The application of electrical current to a peripheral motor nerve is associated with a motor response that results in an uncontrolled, anarchic and exaggerated response of the musculature, which is normalized after the application of the electrical current. In 2016, the authors of the book Invasive Physiotherapy, Fermín Valera and Francisco Minaya, developed by themselves based on the fundamentals of segmental dry needling and neurofunctional acupuncture created by Dr. Alejandro Elorriaga. The authors defined that the application parameters to achieve the best result to the electrical stimulus are controversial, due to the high variability in the literature, but knowing that the most important parameter is the frequency, where studies are observed in which they have used from 2 to 100Hz looking for the motor response. The parameters of the protocol created are: frequency of 10Hz, pulse width of 250us, with a motor or sensory response, performing 8 stimulations of 8 seconds duration, with 8 seconds of rest, with the aim of improving neuromuscular function, muscle recruitment patterns and motor control. Although the scientific basis of the authors were 3 articles, none of which were aimed at improving muscle function, but were for neuropathic pain, chronic pain, and treatment of overactive bladder, the basis of clinical observation is correct and many studies currently using their protocol show improvements at the functional level. In a review of neuromodulation and muscle function, studies that carry out percutaneous stimulation use frequencies of 2Hz to 10Hz, using the protocol of Garrido F. V., Muñoz F. M. , which, as stated above, was not specifically designed to improve muscle function, while the studies that carry out transcutaneous stimulation use much higher frequencies, from 20Hz to 100Hz, all obtaining positive results. For this reason, and the great difference between the frequencies, the need to carry out specific research on the benefits that percutaneous stimulation with a frequency range of 20-100 HZ. The hypotheses of this study are,US-guided PNM, with frequency sweeps of 20Hz -100Hz increases static and dynamic strength, more relevantly than current 10Hz protocols.

The Effect of Different Kinesio Taping Techniques Applied to Patients With Chronic Low Back Pain on the Thoracolumbar Fascia

This study aims to evaluate the effects of functional thoracolumbar fascia kinesiology taping on fascia thickness, pain, and functional disability in individuals with nonspecific chronic low back pain. The study is planned as a randomized controlled trial and will include a total of 30 individuals aged 18-65 years who have been diagnosed with nonspecific mechanical chronic low back pain. Participants will be randomly assigned to two groups: the Functional Fascial Taping Group will receive kinesiology tape applied to the thoracolumbar fascia using a fascia correction technique, while the Muscle Technique Taping Group will receive traditional muscle taping applied to the paravertebral muscles. Interventions will be performed twice a week for two weeks. Assessments will be performed before and after treatment; pain intensity will be measured using the Visual Analog Scale, pressure pain threshold will be measured using an algometer, functional disability will be measured using the Oswestry Low Back Pain Disability Index, and thoracolumbar fascia thickness will be measured using ultrasonography. The findings are expected to contribute to clinical practice by providing evidence-based data on the effectiveness of different kinesiology taping techniques in chronic low back pain.

Blood Flow Restriction Training as a Targeted Intervention for Rowers With Back Pain.

The purpose of this graduate student research study is to compare the effects of low-load blood flow restriction training (LL-BFR) and heavy-load training (HLT) in high-volume rowers with mild low back pain or recurrent low back pain (LBP), aiming to determine whether LL-BFR offers a safer yet equally effective alternative to HLT for enhancing performance and reducing risk of re-injury.

LLLT to Reduce Low Back Pain

The purpose of this research study is to gather information on the effectiveness of the Trident low-level laser therapy (LLLT) in combination with clinical patient education manuals to reduce lower back pain.

A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.

The study aims to evaluate the effectiveness of Multi Angular Isometric Lumbar Exercise (MAILE) in comparison to traditional lumbar stabilization and core stability treatments for managing nonspecific chronic low back pain (NCLBP). MAILE is designed to specifically target the Lumbo-Pelvic Hip complex with the goal of improving pain levels, stability, strength, and overall function. Objectives of the study are to assess several key outcomes: Pain Intensity: Measuring the level of pain experienced by patients. Functional Disability: Evaluating the impact of NCLBP on daily activities and overall function. Functional Stability: Assessing the stability of the Lumbo-Pelvic Hip complex during movement. Muscle Strength: Determining the strength of muscles within the targeted region. By examining these outcomes, the research seeks to determine whether MAILE offers superior benefits and greater cost-efficiency compared to conventional treatments for patients with NCLBP and motor control dysfunction. If successful, MAILE could provide a more effective and economical approach to managing this common and debilitating condition. This Randomized Clinical Trial (RCT) will be conducted across multiple outpatient clinics within the Hamad Medical Corporation (HMC). The study will involve 98 patients diagnosed with non-specific chronic low back pain (NCLBP), who will be randomly assigned to one of two groups: the Multi Angular Isometric Lumbar Exercises (MAILE) group or the Core Stability group. Both groups will follow tailored exercise programs over a three-week period. The MAILE group will focus on exercises designed to enhance lumbar stability and core strength through multi-angular isometric lumbar exercises performed at various angles. These exercises aim to target the deep stabilizing muscles of the lumbar spine, promoting overall spinal stability and reducing pain. The Core Stability group will engage in exercises that emphasize the activation and strengthening of the core muscles, which play a crucial role in maintaining spinal stability and function. The outcomes of this trial will help determine the effectiveness of MAILE compared to traditional core stability exercises in managing NCLBP, potentially guiding future therapeutic strategies.

Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders

This pilot randomized controlled trial aims to compare the clinical effectiveness of advanced high-intensity physical therapy modalities with conventional physical therapy in patients suffering from musculoskeletal disorders. The study focuses on three anatomical areas: lower back, shoulder, and knee. Participants will be randomized into two arms and will undergo 5 therapeutic sessions.

The Effectiveness of Aquatherapy on Physical Performance and Fear of Falling in Geriatric Individuals With Low Back Pain

This randomized controlled trial is designed to evaluate the effects of aquatherapy on physical performance, balance, and fear of falling in older adults with chronic low back pain. Participants aged 65 years and older, with low back pain persisting for more than three months, will be randomly allocated to either an Aquatherapy Group or a Conservative Treatment Group. The aquatherapy intervention will be delivered in a supervised therapeutic pool environment and will consist of a structured exercise program performed three times per week for six weeks (18 sessions in total). Each session will last approximately 45-60 minutes and will include standardized warm-up, main exercise, and cool-down phases. The intervention will utilize the physical properties of water, including buoyancy, viscosity, and hydrostatic pressure, to facilitate postural control, enhance trunk stability, and improve lower extremity muscle strength. The intervention is classified as a non-pharmacological, exercise-based rehabilitation program. No pharmacological agents will be used during the intervention. The conservative treatment group will receive standard land-based physiotherapy, which will include trunk stabilization exercises, stretching exercises, lower extremity strengthening, and balance training, delivered under supervision with the same frequency and duration as the aquatherapy group. Outcome measures will be assessed at baseline and post-intervention. Balance performance will be evaluated using the Biodex Balance System, a computerized posturography device providing objective measures of postural stability. Physical performance will be assessed using the 1-Minute Sit-to-Stand Test (1MSTS), and fear of falling will be measured using the Falls Efficacy Scale-International (FES-I). This study is expected to provide evidence regarding the effectiveness of aquatherapy as a comprehensive rehabilitation approach for improving functional outcomes and reducing fall-related concerns in older adults with chronic low back pain.

Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain

This study is a randomized controlled trial (RCT) investigating whether adding Acceptance and Commitment Therapy (ACT) to standard physiotherapy provides greater benefits for adults with chronic low back pain than physiotherapy alone. A total of 60 participants will be randomly allocated into two groups: ACT plus physiotherapy and physiotherapy alone. Both groups will receive a 8-weeks program with two sessions per week. The ACT component focuses on acceptance, psychological flexibility, mindfulness, cognitive defusion, values, and committed action. The main outcomes are pain catastrophizing, functional disability, perceived stress, and sleep quality, assessed using the PCS, ODI, PSS, and PSQI. The study aims to determine whether combining psychological and physical rehabilitation produces better outcomes than physiotherapy alone.

Comparison Of Early Mobilization And Electrical Stimulation On Functional Recovery After Lumbar Disc Herniation Surgery

This randomized controlled trial aims to compare the effectiveness of early mobilization alone versus early mobilization combined with electrical stimulation on functional recovery following lumbar disc herniation surgery. Lumbar disc herniation is a common cause of low back pain and functional limitation, significantly affecting quality of life. Although surgical intervention is effective in patients who do not respond to conservative treatment, optimal postoperative recovery largely depends on appropriate rehabilitation strategies. Early mobilization is widely recommended to prevent complications, preserve muscle function, and facilitate return to daily activities. In addition, electrical stimulation modalities such as neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) have been increasingly integrated into rehabilitation programs to enhance pain control, muscle activation, and neuromuscular re-education. In this study, a total of 60 participants who have undergone primary lumbar disc herniation surgery will be randomly assigned into two groups. The first group will receive an early mobilization program alone, while the second group will receive early mobilization combined with electrical stimulation (NMES/TENS). The intervention period will last 6 to 8 weeks, with sessions conducted three times per week. Primary outcomes include functional disability measured by the Oswestry Disability Index (ODI) and pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include functional mobility assessed by the Timed Up and Go (TUG) test, walking speed assessed by the 10-Meter Walk Test (10MWT), and muscle strength evaluated using manual muscle testing (MMT). The findings of this study are expected to contribute to the development of evidence-based postoperative rehabilitation protocols and to clarify the clinical effectiveness of electrical stimulation in patients undergoing lumbar disc herniation surgery

Effects of Close Follow-up on Patients With Low Back Pain

This study will include patients aged 18-65 with subacute or chronic mechanical low back pain who apply to the Physical Medicine and Rehabilitation Clinic. The age, gender, body mass index, duration of low back pain, smoking status, and educational status of the patients included in the study will be recorded. Patients will be randomized into two groups: the study group and the control group. First, the psychosocial risk status of patients in both groups will be determined using the STarT Back Screening Tool. Then, patients in the control group will undergo a conventional physical therapy program that includes hot packs, transcutaneous electrical nerve stimulation, ultrasound, and core stabilization exercises. Patients in the study group will undergo daily close follow-up physician-patient meetings during the sessions, in addition to the conventional physical therapy program applied to the control group. Clinical assessments will be performed using the Visual Analogue Scale (VAS), Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Beck's Depression Scale, Roland-Morris Disability Questionnaire, and Leeds Assessment of Neuropathic Symptoms and Signs. Clinical evaluations will be conducted at baseline, on Day 5 post-treatment, and at 1 month post-treatment.

Alberta Back Care Pathway (ABCp)

Every year, the pain, disability, addiction, and expense associated with LBP increase in Alberta. This escalation is largely because most people with LBP seek care from family physicians who are unable to provide effective, guideline-based interventions due to three recognized barriers: 1) a lack of training, 2) a lack of no (or low) cost access to these interventions and 3) a lack of physician time and reimbursement to deliver these interventions. As a result, most LBP care provided in Alberta is "low-value". With input from Alberta patients, healthcare providers, administrators and international scientists, the Alberta Back Carepathway (ABCp) was designed to overcome these barriers by giving family physicians a common, guideline-based approach to coordinate, assess and manage LBP patients in day-to-day practice. The ABCp trains family physicians to quickly and easily place patients into 5 categories each having evidence-based interventions that can be provided by physicians at no or low cost to patients and no net cost to the healthcare system. By designing the ABCp to resolve barriers related to training, access and delivery, the ABCp will "pull" rather than "prod" patients and clinicians toward sustained, long-term implementation of this cost-effective solution. This study is based on a multi-clinic, controlled, non-randomized stepped-wedge study designed for urban and rural primary care networks (PCNs). The primary outcome will be decreased healthcare resource utilization with secondary improvements in quality of life and opioid consumption. Overall, the savings realized through ABCp will create a self-sustaining, scalable solution for LBP care in Alberta.

Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain

This randomized controlled trial aims to evaluate the effects of gamified home-based core neuromuscular training on pain intensity, functional disability, core muscular endurance, and exercise adherence in women with chronic nonspecific low back pain. Participants will be randomly allocated in a 1:1 ratio to either a gamified intervention group or a non-gamified control group. Both groups will perform the same progressive core exercise program. The intervention group will use a digital application with gamification features, while the control group will perform the exercises without gamification. Outcomes will be assessed at baseline, week 3, and week 6. The study will determine whether gamification provides additional benefits over conventional home-based exercise in improving clinical outcomes and exercise adherence in women with chronic nonspecific low back pain.

Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)

This study aims to compare the effects of Motor Control Exercises (MCE) with and without Pressure Biofeedback-Guided Training in patients with recurrent low back pain. It will evaluate the effectiveness of both interventions in reducing pain, improving Transversus abdominis (TrA) muscle activation, and decreasing disability. The study will determine whether adding pressure biofeedback to motor control exercises provides better clinical outcomes than motor control exercises alone.

Evaluation of Balance Using the Biodex Balance System Among Different Subcategories of Low Back Pain

this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse.

EFFICACY OF ARTIFICIAL INTELLIGENCE DRIVEN PROGRAM VERSUS TRADITIONAL PHYSICAL THERAPY PROGRAM IN PATIENTS WITH LOW BACK DYSFUNCTION

Low back dysfunction is one of the most common musculoskeletal disorders and is associated with pain, disability, and reduced quality of life. Artificial intelligence (AI) has emerged as a promising tool to support personalized rehabilitation by improving exercise prescription, monitoring adherence, and providing real-time feedback. This randomized controlled trial aims to compare the effectiveness of an AI-driven rehabilitation program with a traditional physical therapy program in patients with low back dysfunction. Primary outcomes include pain intensity, functional disability, and quality of life. The findings may provide evidence regarding the role of AI-assisted rehabilitation in improving clinical outcomes.

Overlapping Pain Trajectory Study

The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: * quantitative sensory testing * blood draw * sleep assessment * questionnaires

Therapeutic Exercise and Education for Low Back Pain

This study will evaluate a new treatment program for patients with ongoing or long-term low back pain who receive care at primary care physiotherapy units. Participants with subacute or chronic nonspecific low back pain will be randomly divided into three groups for comparison of their progress. The first group will receive an eight-week program of therapeutic exercise and health education, which will be delivered entirely online. The second group will receive the same exercise and education program in face-to-face sessions. The third group will receive standard physiotherapy care. The study will last eight weeks, and researchers will follow up with participants three months later. The project's main goal is to measure changes in participants' daily disability levels. The researchers will also examine other important factors, such as pain intensity, fear of movement, anxiety, depression, quality of life, and overall satisfaction with the care received. Measurements will be taken before the study begins, immediately after the eight-week program ends, and at the three-month follow-up. This trial aims to find more accessible, evidence-based ways to treat back pain, reduce hospital waiting lists, and improve patient well-being by combining digital and in-person care.

The Effect of Exercise and Ergonomics Training Program on Musculoskeletal Disorders in Teachers

This randomized controlled trial tested whether adding a 12-week structured exercise program to ergonomics training improves low back and neck disability, burnout, musculoskeletal symptoms, and pain intensity in schoolteachers with musculoskeletal pain, compared with ergonomics training alone. Eighty teachers from preschool, primary, middle, and high schools in Tatvan (Bitlis, Türkiye) were stratified by school level and randomized 1:1. Outcomes were assessed at baseline and at week 12.

The Effect of Exercise on Motion Perception and Fear in Low Back Pain

Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Contrary to what is known, this cycle aggravates pain. With this result, it is suggested that the exercise to be done will improve the perception of benefit in the person and eliminate the fear of movement, and that it will cure the disease. In this context, the aim of the study is to examine the effect of exercise on the perception of exercise and fear of movement in patients with NLBP.

Contextual Effects on Inflammatory Biomarkers and Pain Relief After Spinal Joint Manipulation

The goal of this clinical trial is to learn whether contextual effects created by observational learning can change pain relief and inflammation-related biological responses after spinal joint manipulation in adults with chronic non-specific low back pain. The main questions it aims to answer are: Does positive, neutral, or negative observational learning change pain after spinal joint manipulation? Does it change disability, lumbar range of motion, stress, fear of movement, empathy, and treatment expectations? Does it change pressure pain threshold, lumbar tissue temperature, and blood markers related to inflammation, including interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10)? The researchers will compare 3 groups: a positive expectation group, a neutral group, and a negative expectation group. Before the treatment, each participant will have a short interaction with a trained simulated patient. The simulated patient will present a positive, neutral, or negative experience with spinal manipulation, depending on group assignment. After this, all the participants will receive the same spinal joint manipulation procedure. The participants will: * be randomly assigned to 1 of 3 study groups, * complete baseline questionnaires and clinical tests before treatment, * take part in a brief observational learning session before manipulation, * receive 1 spinal joint manipulation treatment, * complete outcome measurements before treatment, about 60 minutes after treatment, and 24 hours after treatment, * provide blood samples for analysis of inflammation-related biomarkers. This study will include adults aged 18 to 65 years with chronic non-specific low back pain. The main outcome is pain intensity. Secondary outcomes include disability, stress, empathy, fear of movement, lumbar range of motion, tissue temperature, pressure pain threshold, and treatment expectations. Exploratory outcomes include blood biomarkers related to inflammation.

Multi-Omics Characterization of Percutaneous Electrolysis in Low Back Pain

Low back pain is a highly prevalent musculoskeletal condition and is frequently associated with structural and functional alterations of the lumbar multifidus muscle. Percutaneous electrolysis is an ultrasound-guided invasive physiotherapy technique increasingly used in the management of musculoskeletal pain; however, its underlying biological mechanisms remain poorly understood. The aim of this study is to investigate the biochemical and molecular effects of percutaneous electrolysis applied to the lumbar multifidus muscle in patients with low back pain. A multidisciplinary, blood-based multi-omics approach will be used to explore systemic biochemical changes induced by the intervention. In this preliminary controlled study, blood samples will be collected from participants before and after treatment and analyzed using proteomic and lipidomic techniques. Multivariate statistical and bioinformatic analyses will be performed to identify proteins, lipids, and metabolic pathways that are significantly modulated by percutaneous electrolysis compared with a control procedure. The results of this study are expected to contribute to a better understanding of the physiological and biochemical mechanisms of action of percutaneous electrolysis and to support the identification of potential blood biomarkers associated with its therapeutic effects in low back pain.

Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain

The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims. Specific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels. Specific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +/- relationships (R\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\>.1) +/-relationships between hormone measures and PROMIS pain/disability/depression measures, which reflects similar findings to preliminary work. Participants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.

Evaluation of the Comfort Increase Provided by an Additional Foam Pad on a Lumbar Belt and Its Biophysical Impact

The spine is the central musculoskeletal system of the back. It carries and supports a major part of the body weight and ensures simultaneously the trunk's mobility, particularly the mobility of the lumbar spine and the head's mobility by moving the cervical spine. Back pain in the lumbar spine area is the most common kind of pain with a prevalence of 60 to 70 per cent in industrialized countries (Jellema2001).

Mobile App-Assisted Home Exercise for Musculoskeletal Disorders

Overview This study evaluates the effectiveness of a dedicated mobile health (mHealth) application in supporting home exercise programs for patients with musculoskeletal disorders, such as neck, shoulder, back, or knee pain. The research aims to address the widespread challenge of low patient adherence to unsupervised home-based exercises. Study Design The project employs a dual-methodology approach: Clinical Trial: 30 participants presenting with neck, shoulder, back, or knee pain will be randomly assigned to either an app-assisted group or a traditional home exercise group. Both groups will undergo 4 weeks of physiotherapy. The study will compare pain intensity, physical function, and exercise adherence between the two cohorts. Retrospective Analysis: To complement the trial, the study will analyze a large-scale database containing approximately 700,000 anonymized real-world data entries. This analysis aims to observe real-time pain fluctuations before and after exercise sessions within routine clinical settings. Goal The primary objective is to determine if integrating mHealth technology into traditional rehabilitation can enhance clinical outcomes and improve patient adherence to home-based exercise routines.