Clinical Research Directory

Examination of Nociscan Impact on Low Back Pain Surgical Outcomes

This study is looking into how useful NOCISCAN is. NOCISCAN is a software as a Service (SaaS) tool that uses Magnetic Resonance (MR) spectroscopy. Nociscan leverages MRS to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The randomized controlled trial will compare the blinded and unblinded cohorts and their corresponding surgical outcomes with the Nocigram reports, generated prior to treatment, for each patient.

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.

Effects Of Quadratus Lumborum Release on Respiratory Outcomes on Low Back Pain Patients

The aim of this research is to check the effects of Quadratus Lumborum (QL) release on respiratory function and pain levels in individuals with chronic low back pain. Randomized controlled trials done at Pakistan Railway General Hospital, Rawalpindi and Rawal General \& Dental Hospital Islamabad. The sample size was 36. The subjects were divided into two groups, 18 subjects in the experimental group will receive muscle energy technique on quadratus lumborum along with conventional intervention for LBP and 18 in control group will only receive conventional intervention exercises for LBP. Study duration was of 6 months. Sampling technique applied was non probability connivance sampling technique. Only 30-60 years both males and females diagnosed with mechanical low back pain persist at least \>3 months. Tools used in the study of Numeric Pain rating scale (Pain assessment). Modified Oswestry Disability Index (m-ODI) (for ADLs in CLBP). Inclinometer (for ranges of lumber spine). Digital spirometer (for FEV1/FVC ratio). Inches Tap (For Chest Expansion) \& (For Quadratus lumborum length test). Fatigue Severity Scale (FSS).

Effect of Vibration Massager Therapy on Non-Specific Low Back Pain

The main purpose of this study was to examine the effects of vibratory massage therapy on individuals with non-specific low back pain.

Coach2Move: Physical Therapy to Improve Physical Activity in Individuals With Chronic MSK Conditions

Chronic musculoskeletal conditions (chronic low back pain, knee osteoarthritis, hip osteoarthritis) are the most common causes of long-term disability resulting in a loss of quality-of life for affected individuals and high costs for society. Regular physical activity can reduce disability and improve quality-of-life but can be challenging in the presence of pain and impaired function. This proposal addresses an urgent need for interventions that support physical activity in this population by leveraging the physical therapy intervention to address symptoms of chronic musculoskeletal conditions and support long-term physical activity engagement.

Multifidus PET Scan Study

The study involves investigating phenotypic changes (ie metabolic activity in brain pain matrix areas, metabolic activity and textural analysis of multifidus muscle) following multifidus stimulation and establishing relationship with the change in pain, functionality and quality of life.

Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain

The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of chronic low back pain (CLBP). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control

Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU). In addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and/or leg pain.

Comparing Yoga Nidra, Yoga, and Control Condition on Pain in Individuals With Chronic Low Back Pain

Individuals with chronic low back pain will undergo a yoga, yoga nidra, and control condition on separate visits. Each visit, before and after the intervention, participants with rate their pain in response to heat stimuli, a sit to stand task, and questionnaires.

Telerehabilitation After Spine Surgery

The goal of this randomized clinical trial is to assess how different methods of delivering post-operative instructions affect the participants' recovery after spinal decompression surgery. In addition, the investigators evaluate the related healthcare costs and the use of healthcare services in both working-age and elderly populations. The main research questions of the study are: 1. Does the method or timing of post-operative information influence healthcare utilization or recovery after surgery? 2. Are telerehabilitation methods easily accessible and usable for the elderly population? 3. Does early intervention provided in the hospital lead to different recovery times after surgery? The outcome measures include pain levels, daily activity levels, and healthcare utilization. The results will be compared between study groups based on the information delivery method and age group.

Identification of Risk Factors for Recurrence of Low Back Pain and Occupational Repercussions

Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33 % rate of recurrence during the first year, converting LBP into a chronic condition. The french High healthy authority recommend early occupational oriented intervention associated with a multidisciplinary rehabilitation program. However even if these recommendations are taken into appropriate account, risk for recurrence of Low back pain and occupational repercussions often occured. This study aims to identify the risk factor(s) of sick leave after a rehabilitation stay in outpatients and thus adapt cares provided to the patients in respect of their needs and expectations.

High-Intensity Interval Training in Young Women With Mechanical Low Back Pain

This randomized controlled trial evaluated the effects of a 4-week high-intensity interval training (HIIT) program on pain, functional disability, body composition, cardiorespiratory fitness, and quality of life in young women with mechanical low back pain. Participants were randomly allocated to either a supervised HIIT cycling program or a control exercise program consisting of stretching and low- to moderate-intensity treadmill walking. Outcomes were assessed at baseline and after completion of the 4-week intervention.

Effectiveness of the SelfBack-App in Preventing and Treating Low Back Pain Versus no Intervention: a Non-randomized Clinical Trial

Low back pain (LBP) is the leading cause of disability worldwide and represents a major burden for both individuals and healthcare systems. In Belgium, more than one in five adults experiences an episode of low back pain each year. Healthcare workers, including nurses, nursing assistants, and logistical staff, are particularly vulnerable because of the physical demands of their profession. Daily activities such as patient handling, prolonged standing, repetitive movements, and manual lifting increase their risk of developing low back pain. As a result, these complaints can affect not only the health and well-being of employees but also their work ability, sickness absence, and, ultimately, the continuity and quality of patient care. The present study evaluates the effectiveness of the SelfBack app, a digital self-management tool developed to support people with non-specific low back pain. The application uses information provided by the user, together with data recorded by a step counter, to create a personalised weekly programme. This programme includes exercises, walking goals, and educational material, all of which are adapted to the user's symptoms, progress, and individual needs. The study will be conducted at Universitair Ziekenhuis Brussel and Valida and will include nurses, nursing assistants, and logistical staff who experience non-specific low back pain. Hospital departments will be assigned to either the intervention group or the control group. Participants in the intervention group will receive access to the SelfBack app in addition to their usual care, while those in the control group will continue to receive usual care only. The main objective is to determine whether the use of the SelfBack app improves low back pain-related functional disability after three months. Functional disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ), a widely used and validated questionnaire for people with low back pain. In addition to the primary outcome, the study will examine the effects of the intervention on pain intensity, work ability, physical activity, health-related quality of life, and psychological factors such as fear of movement and self-efficacy. Participants' experiences with the application will also be explored. Data will be collected through online questionnaires at baseline and after 3, 6, and 12 months. The SelfBack app is a CE-marked Class I medical device, and no serious adverse events are expected. All personal data will be handled in compliance with the General Data Protection Regulation (GDPR). The results of this study will help determine whether a personalised digital self-management programme can provide additional benefits when used alongside standard care for people with non-specific low back pain.

Effect of Tele-Rehabilitation on Low Back Pain, Fatigue, and Psychological Well-being in Postpartum Women Following C-Section

The goal of this study is to learn whether tele-rehabilitation helps postpartum women recover from low back pain after a cesarean section (C-section). The study will also look at whether tele-rehabilitation helps reduce fatigue, improve psychological well-being, and make daily activities easier. The main questions it aims to answer are: * Does tele-rehabilitation reduce low back pain in postpartum women after a C-section? * Does it reduce postpartum fatigue? * Does it improve psychological well-being? * Does it improve the ability to perform daily activities? Participants will: * Be selected using a computer-generated random sampling method from eligible postpartum women. * Complete assessments before and after the treatment program. * Receive therapeutic exercises and ergonomic education through tele-rehabilitation if assigned to the intervention group. * Receive ergonomic education about posture, breastfeeding, lifting, carrying, and back care if assigned to the control group. * Complete questionnaires about their pain, fatigue, psychological well-being, and ability to perform daily activities. The study may help determine whether tele-rehabilitation is a practical way to provide physiotherapy support to women recovering at home after a C-section.

Virtual Tai Chi for Chronic Low Back Pain (Spine 2027)

This study tests whether a virtually delivered integrated tai chi, qigong, and meditation program, added to usual care, improves chronic low back pain, disability, quality of life, and healthcare costs compared with usual care alone. Adults with chronic low back pain are randomized to begin the program immediately (Tai Chi Now) or after a six-month period (Tai Chi Later). Outcomes are collected by online survey over twelve months.

Core Endurance Versus Segmental Stabilization Exercise in Recreational Athletes With Low Back Pain

Low back pain is a common musculoskeletal complaint among athletes, and most cases are classified as non-specific low back pain, in which no clear anatomical or pathological source of pain can be identified. Recreational athletes, who exercise regularly for health and fitness rather than for competition, often have less structured training planning and technical supervision than professional athletes, which may increase their susceptibility to musculoskeletal complaints. Core stability has become an important consideration in the prevention and management of low back pain. The core region includes the abdominal muscles, paraspinal muscles, diaphragm, and pelvic floor muscles, and plays an important role in maintaining spinal stability. Reduced activation and endurance of these muscles may increase the load on the lumbar spine and contribute to the development of low back pain. This randomized trial compares two exercise approaches in recreational athletes with non-specific low back pain: a core endurance exercise program and a segmental stabilization exercise program targeting the transversus abdominis and lumbar multifidus. Participants are randomly assigned to one of the two programs, both delivered three days per week for six weeks under physiotherapist supervision. Pain and functional status, dynamic balance, and core muscle endurance are assessed before the program and at the end of the six-week program.

Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain

The aim of this trial is to assess the effectiveness and cost-effectiveness of a supervised and more personalised mhealth intervention compared with conventional exercise therapy in people with chronic non-specific low back pain.

Digitally Delivered Treatments to Reduce Chronic Low Back Pain

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Effect of an Intervention Based on Back School in an Aquatic Environment on Non-specific Low Back Pain

A controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (EG) (individuals who will attend the in an aquatic program based on the back school) and in the control group (CG) (individuals who will not attend the in an aquatic program based on the back school). The experimental procedure will follow the recommendations of the CONSORT and TidIER guidelines. The study protocol will be approved by the Research Ethics Committee of the University of Vigo. This study will be conducted under the Declaration of Helsinki (2013 version). Participants will sign a written informed consent after being informed of the benefits and risks of the research. Participants in the EG will participate in an aquatic program based on the back school. This program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. The intervention will be carried out by physiotherapists in a sports centre. The duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. Of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.

Comparison of the Effectiveness of Two Different Squat Exercises in Healthy Individuals

The aim of our study is to compare the effects of two different squatting patterns, with and without the knees passing the toes, on low back pain, muscle strength and balance.

Stratified Targeted Engagement From Primary Care to Physical Therapy (STEPPT)

The goal of this clinical trial is to learn if a health system intervention called "Stratified Targeted Engagement from Primary Care to Physical Therapy (STEPPT)" can improve how often doctors refer Hispanic patients with spine pain to physical therapy (referral rate) and how often patients attend physical therapy after being referred (adherence rate). The main questions this study aims to answer are 1) does STEPPT improve physical therapy referral and adherence rates compared to usual care for Hispanic patients with spine pain who seek care in a Federally Qualified Health Center (FQHC) serving low income communities, and 2) how consistently do FQHC providers and staff deliver STEPPT to patients who may benefit? STEPPT will train doctors and other health care providers to educate participants on the benefits of physical therapy for spine pain and participants will receive culturally tailored handouts and videos to teach them about their spine pain and what to expect in physical therapy. Patients will also receive personalized assistance to schedule their physical therapy appointment and address potential barriers for attending the appointment.

Back to Life - Early Rehabilitation Therapy for Patients Undergoing Lumbar Spinal Fusion

Aim This study aims to assess the effectiveness of an early intervention comprising individually tailored physiotherapy, including dialogue, education, and graded activity, following lumbar spinal fusion surgery. The effectiveness will be evaluated on patient-specific goals, physical activity, pain intensity, pain interference, fear of movement, and pain self-efficacy for patients after a lumbar spinal fusion.

Motor Imagery Training in Non-Specific Low Back Pain

Low back pain is a significant global health issue, affecting a large proportion of the population at some point in their lives. Among the different types of low back pain, non-specific low back pain is the most common. Chronic low back pain has been shown to impact trunk endurance, functional capacity, fatigue, anxiety, and depression levels. Neuroscience-based studies aimed at improving pain management have demonstrated that chronic pain is associated with not only peripheral changes but also central changes. These central changes include abnormalities in the distribution of sensory cortical processing, disinhibition of the motor cortex, and disturbances in body schema perception. Studies have shown that motor imagery training, defined as the mental simulation of movement without actual execution, functions as a cortical-level training method and has positive effects on impaired body schema perception, thereby reducing pain. A review of the literature indicates that motor imagery training contributes to the treatment of pathological pain syndromes such as complex regional pain syndrome, brachial plexus avulsion injury, phantom limb pain, distal radius fracture, and stroke by modulating cortical mechanisms. However, no randomized controlled trials have investigated the effectiveness of adding motor imagery training to exercise therapy in individuals with non-specific chronic low back pain, specifically regarding its impact on physical function and psychosocial parameters. The aim of this study is to investigate the effects of a motor imagery training protocol, applied in addition to exercise therapy, on pain, physical, and psychosocial parameters in individuals with non-specific chronic low back pain. A total of 32 individuals with chronic non-specific low back pain will be included in the study. Participants will be randomly assigned to either the intervention or control group. All participants will receive telerehabilitation-based exercise therapy under the supervision of a physiotherapist. In addition to the exercise therapy, participants in the intervention group will undergo asynchronous motor imagery training every day for eight weeks, while the control group will receive only exercise therapy. Assessments will be conducted three times: before treatment, at the end of the 8-week intervention, and at the 12th week follow-up. All assessments will be performed through a telerehabilitation-based approach. The study will evaluate participants' pain, fatigue, disability level due to low back pain, anxiety and depression levels, and physical function.