Clinical Research Directory

Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

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.

Biomechanical Validation of the Caregiver Assisted Transfer Technique Instrument

As of 2020, 53 million Americans provide unpaid care to an individual with a disability. One commonly performed activity of daily living (ADL) provided by informal caregivers is assisted transfers, which requires moving an individual from one surface to another. Approximately 94% of informal caregivers who assist with ADLs to persons with adult-onset chronic physical disabilities affecting mobility reported musculoskeletal discomfort, with pain and discomfort made worse by performing caregiving activities. Although many informal caregivers assist with transfers, most have never received any formal training in proper manual lifting or mechanical lifting techniques. Improper transfer techniques can be detrimental to not only caregiver health but also to the persons they assist resulting in shoulder injury, bruising and pain from manual lift techniques, hip fractures from falls, and skin tears from shear force that occurs with sliding during transfers. Current standard of care provides limited in-person training of caregivers, as most of the rehabilitation process is client-focused. When training is provided clinicians have no means to objectively evaluate if proper techniques are being performed at discharge or when the caregiver and care recipient return home. For this reason, an outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT evaluates the caregiver's performance on setup, quality of the task performance, and results. After a formal assessment through stakeholder review involving clinicians, informal caregivers, and individuals with physical disabilities who require transfer assistance, the CATT was expanded to include two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). However, the CATT must undergo further testing with informal caregivers and the individuals they assist to determine if the CATT is a reliable, valid, and responsive tool for identifying skill deficits in caregivers performing assisted transfers. The purpose of this study is to establish the psychometric properties (reliability, validity, and responsiveness) of the CATT and to evaluate the effects of an individualized training session for participants who have transfer technique deficits as identified by the CATT. The long-term goal of this research is to develop the CATT so that it can be used as an objective indicator of transfer performance as well as guide training and educational interventions for informal caregivers to reduce the risk of musculoskeletal pain and injury associated with assisted transfers.

Hamstring Stretching Effective on Nonspecific Low Back Pain

Low back pain is one of the most common complaints in the world and can be considered a universal health problem for humanity. Low back pain is a multifactorial disease with multiple etiologies. Risk factors are difficult to identify. It is reported in the literature that 70-80% of the world's population has low back pain at some point in their lives, and 95% of this pain is mechanical. Mechanical low back pain (MBA) can be described as a clinical picture that develops as a result of overuse, strain, traumatization or deformation of the structures that make up the spine. In order to define low back pain mechanically, all organic causes such as inflammatory, infectious, tumoral, metabolic causes, fractures and pain reflected from internal organs must be excluded. The most common diseases that cause low back pain are; They are caused by mechanical factors and degenerative diseases. Mechanical and static stresses can lead to joint blockage, restricting the range of motion of the joint along with pain. Non-Specific many factors affect low back pain. Kim and Shin reported that asymmetry of hip extension range of motion of both hip joints was associated with nonspecific low back pain rather than simple hip extension range of motion, and they found that limiting hip extension was compensatory.

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.

Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain

Implementing workplace strategies to manage symptoms in office workers with chronic nonspecific spinal pain (CNSP) may improve both health- and work-related outcomes, as adherence to these interventions is more feasible in this context. Exercise therapy is considered the first-line treatment for CNSP; however, the added value of combining exercise therapy with manual therapy remains inconclusive. This study aims to examine the effects of short sessions of exercise therapy plus manual therapy, compared with exercise therapy plus sham manual therapy, delivered in the workplace, on health- and work-related outcomes in office workers with CNSP.

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.

Effect of Kinesio Taping Application in Addition to Pilates Exercises on Core Muscle Thickness, Cognition and Mental Fatigue in Individuals With Non-specific Low Back Pain

Low back pain is a common problem. In low back pain, the core region and posture are frequently affected. However, no definitive decision has been reached regarding cognition and mental fatigue. In the treatment of low back pain, exercise and kinesio taping approaches are frequently used. The aim of this study is to evaluate the effects of kinesio taping applied in addition to pilates exercises on pain, core muscle thickness, strength and endurance, posture, cognition and mental fatigue in individuals with non-specific low back pain and to compare it with placebo taping and the control group. The primary outcome measure of this study is core muscle thickness, while other measurements will be considered as secondary outcomes.

Post Facilitatiion Stretch and Dry Needling on Hamstring Tightness in Chronic Low Back Pain

The aim of this research is to compare the effects of post-facilitation stretch and dry needling on hamstring flexibility, pain, lumbar range of motion, pelvic tilt, and functional status in patients with chronic low back pain. This randomized clinical trial will be conducted at Spine Care Physical Therapy and Rehabilitation Centre (SPRC), Peshawar. The sample size will be 36 participants, who will be randomly divided into two groups: 18 participants in the post-facilitation stretch group and 18 participants in the dry needling group. The study duration will be 3 weeks, with interventions applied three times per week. The sampling technique used will be non-probability purposive sampling, followed by random allocation using the sealed opaque envelope method. Participants aged 20-50 years diagnosed with chronic nonspecific low back pain and having hamstring tightness will be included. Outcome measures used in the study will be Active Knee Extension Test (goniometer) for hamstring flexibility, Numeric Pain Rating Scale (NPRS) for pain, goniometer for lumbar flexion and extension, pelvic inclinometer for pelvic tilt, and Modified Oswestry Disability Index (MODI) for functional disability.

The Relationship Between Transversus Abdominis Muscle Architecture and Upper Extremity Function in Patients With Chronic Low Back Pain

Core stability is the ability to control the position and movement of the trunk for optimal production, transfer, and control of forces in the upper and lower extremities during functional activities. Studies have shown that TrA activation is delayed in individuals with low back pain. The relationship between core stability and the lower extremity has been frequently studied in the literature, and according to Kibler's 'Kinetic Chain' theory, loss of proximal stability is known to lead to dysfunction in distal segments; however, the relationship between the upper extremity and core stability is still unclear. The aim of our study is to investigate the upper extremity reach capacity and scapular stability of individuals with low back pain in relation to TrA involvement and to compare them with healthy individuals without low back pain.

POS Mobilization by 3-DRT Affect Functional Outcome in Layered Syndrome

I aim to study the effects of posterior oblique sling mobilization by 3-D release technique on pain, range of motion and functional disability in layered syndrome

Global Myofascial Treatment With Shockwave for Non-Specific Low Back Pain

This study aims to examine the effects of shockwave therapy on myofascial tissue (muscles, fascia, and connective tissue), focusing on pain reduction and improvement of mobility. The results will be compared with those of conventional manual physiotherapy. Myofascial tissue can be a source of back pain, as it may contain painful spots known as myofascial trigger points (MTrPs). Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain. The study investigates how focused shockwave trigger point therapy influences back function and pain perception compared to traditional physiotherapeutic treatment. Participation is voluntary. The examinations will only be carried out if you provide written informed consent. You may refuse participation or withdraw your consent at any time without any disadvantages.

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

This multi-center registry study aims to evaluate the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals. Eligible participants must have a pain Numeric Rating Scale (NRS) of 5 or higher for their most dominant spinal pain, which includes neck pain with upper extremity radiating pain, or low back pain with lower extremity radiating pain. As a non-interventional observational study, it will include patients who are already planned to receive ultrasound-guided pharmacopuncture as part of their routine clinical care. The primary outcome is the change in the most dominant spinal pain intensity measured by the NRS from baseline to 4 weeks. Secondary outcomes include functional disability evaluated using the Neck Disability Index (NDI) or Oswestry Disability Index (ODI), quality of life using the EQ-5D-5L, and patient satisfaction. Safety will be closely monitored by assessing all adverse events at every visit, evaluating their incidence, severity, and causality related to the procedure. Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.

Investigation of Spinal Health and Internet Addiction of Individuals Working Remotely

Low back pain and neck pain are common problems that affect people at certain times in their lives. These people constitute a significant part of the disease burden due to their recurrent complaints. People with low back and neck pain often seek medical attention. This situation causes individuals to apply to the hospital frequently and causes a serious cost at the social level. When the risk factors for neck pain are examined, many factors such as genetics, sleep problems, smoking, obesity, sedentary lifestyle, poor posture, previous neck pain, trauma, back pain and poor general health cause neck pain to develop. Similarly, conditions such as age, obesity, and poor general health appear to be risk factors for low back pain. In addition to these risk factors, it has been reported that occupational factors such as long and sedentary working hours and unsuitable workplace conditions may also cause low back and neck pain. Fixed posture and prolonged sitting are thought to be risk factors for low back and neck pain, but opinions on this subject are not clear. The COVID-19 pandemic has created a global crisis since 2019 and caused a change in the lifestyle of all people around the world. The World Health Organization (WHO) stated that social distance should be increased and face-to-face contact should be reduced to prevent the spread of the pandemic. For this reason, many institutions have decided to work remotely and trainings have been carried out remotely. The increasing teleworking style with the COVID-19 pandemic has led to an increase in the average screen time of individuals. It was reported that time spent on the Internet increased by 52% compared to the pre-pandemic period. This study aims to investigate the relationship between increased teleworking hours and internet use during the pandemic period in individuals with low back or neck pain. Researchers think that postural changes that may occur with increased distance working time, increased fixed posture and asymmetrical loading may contribute to the uncertain relationship between low back and neck pain and posture.

Comparison of Traditional, Synchronous, and Asynchronous Telerehabilitation in Office Workers With Chronic Nonspecific Low Back Pain

Chronic Nonspecific Low Back Pain (NLBP) is a common condition that occurs without a specific underlying pathology, resulting in muscle tension, pain, and a decreased quality of life. Office workers are particularly at risk due to prolonged sitting, ergonomic errors, and low physical activity. While exercise therapy is a primary approach for management, low adherence rates often limit its effectiveness. Telerehabilitation (remote, technology-supported physiotherapy) stands out for its potential to increase access and support continuity of care. This study is a randomized controlled trial that will be conducted with 45 office workers aged 18-65 diagnosed with chronic NLBP. Participants will be randomly assigned to three parallel groups: traditional exercise (brochure-based), synchronous telerehabilitation (live sessions), and asynchronous telerehabilitation (pre-recorded videos). The intervention protocol will be implemented for 8 weeks. Evaluations will be performed before and after the 8-week period using the Visual Analog Scale (VAS) for pain intensity, Oswestry Disability Index (ODI) for functional disability, Short Form-36 (SF-36) for health-related quality of life, and a Patient Satisfaction Questionnaire. The aim of this study is to compare the effects of traditional, synchronous, and asynchronous telerehabilitation approaches on pain, disability, quality of life, and satisfaction to determine the most effective management model for office workers with chronic nonspecific low back pain.

Effectiveness of Coordinated Care to Reduce the Prolonged Disability Risk Among Patients Suffering From Low Back Pain in Primary Care

Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists. A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals. The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.

Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.

Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Chronic Low Back Pain

The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA. The main questions it aims to answer are: * Does TEA reduce pain intensity more effectively than sham TEA? * Does TEA improve quality of life compared with sham TEA? * Does TEA reduce the frequency of bothersome pain episodes? * Does TEA reduce the use of routine and additional (extra) pain medications? * What side effects occur in participants receiving TEA compared with sham TEA? Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain. Participants will: * Receive a single session of TEA or sham TEA * Continue using pain medications as prescribed by their physician * Be evaluated at weeks 2, 4, 6, and 8 after treatment * Complete pain assessments, quality-of-life questionnaires, and reports of pain episodes and medication use * Attend in-person clinic visits at weeks 4 and 8, and receive telephone follow-ups at weeks 2 and 6

Effect of Dry Needling Plus Vibration on Myofascial Trigger Points in Individuals With Nonspecific Low Back Pain

Low back pain is one of the most common health issues worldwide, and in most cases, this pain is nonspecific low back pain (NSLBP). NSLBP is characterized by the inability to determine the real source of the pain and commonly presents with myofascial trigger points (MTrPs) in the muscles related to the lumbar region. One of the most widely used techniques for treating NSLBP by targeting MTrPs is dry needling (DN), a technique that involves inserting a needle to produce a mechanical effect capable of "deactivating" the MTrP and thereby alleviating its symptoms. However, some studies have concluded that other techniques are more effective than DN, such as percutaneous electrolysis (PE). When using the PE technique, it appears that adding a galvanic current enhances the effects of DN. Nonetheless, this poses a greater risk to the patient, as the galvanic current could damage nervous tissue if it comes into contact. For this reason, it is proposed to investigate whether other physical agents that are not electrical could enhance the effect of DN without increasing its risk. This is the case for vibration, a stimulus that has already been used successfully for the treatment of MTrPs, allowing us to investigate whether adding vibration to DN introduces therapeutic capabilities that: * Maintain or increase the effectiveness of DN in terms of pain and functional capacity. * Do not add risks for the patient, unlike PE. * Are less painful than DN and cause less post-needling pain than that generated after successive needle insertions with DN. Emphasizing these adverse effects is necessary since most clinical trials do not report these variables, which is fundamental for describing the safety of invasive techniques. Following this idea, the present project will analyze a new invasive therapy for the treatment of MTrPs: dry needling with vibratory stimulus (DN+V), for which the following hypotheses are proposed: * DN+V, instead of using an electrical stimulus like PE that could cause damage to some tissues, will apply vibration to the DN needles to increase the mechanical stimulus exerted on the MTrP, expecting greater benefits in terms of pain, functional capacity, muscle strength, and other variables of interest in individuals with NSLBP, and possibly requiring less treatment time than DN. * In DN, the repeated insertions and withdrawals of the needle in the MTrP provoke a hemorrhagic and inflammatory reaction that translates into hypersensitivity and microscopic tissue injury in the muscle, causing pain during treatment and post-needling pain for the following 24-32 hours. Another study showed that PE caused less post-needling pain than DN, which may be due to the fact that, unlike DN, it is common in PE to only perform a single puncture with each needle and not mobilize them. * The methodology for DN+V will be the same as for PE, with a single puncture and no needle manipulation, so it is expected that DN+V, being less invasive than DN, will reduce pain during treatment and post-needling pain compared to that generated by DN. There are studies that support this hypothesis, concluding that needle manipulation in DN produces greater post-needling pain than DN without needle manipulation.

Three CT Signs of Nerve-root Suffering in Low-back Sciatica: a Study of Their Frequency in Patients Referred for CT-guided Nerve-root Infiltration.

Retrospective, observational, single-centre study conducted at Nice University Hospital (Pasteur 2), Department of Diagnostic and Interventional Radiology. Objective: to assess the prevalence of three CT signs sought next to the clinically suspected nerve root in patients with low-back sciatica referred for CT-guided foraminal/peri-radicular infiltration: (1) nerve-root size asymmetry/hypertrophy, (2) peri-radicular infiltration, and (3) spontaneous root hyperdensity. Hypothesis: these signs are associated with the suffering nerve root responsible for the clinical presentation. Pre-infiltration planning CT scans (period 30 Jan 2024 - 11 Jul 2024) are reviewed by the operating radiologists (4th-, 5th- and 6th-year residents). Target enrollment: 400 patients. Data analysed to date: 104 patients / 105 infiltrations. Preliminary prevalence: root asymmetry/hypertrophy 45.5%; peri-radicular infiltration 50.5%; spontaneous hyperdensity 23.8%; at least 2 of 3 signs 38.6%; all 3 signs 16.8%. Mean age 65 years (range 25-93); approximately 62 women / 42 men; predominant levels L4-L5 and L5-S1.

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.

The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation

This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes. Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device. The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.

State vs. Trait Alterations in Low Back Pain

The primary goal of this study is to investigate whether different alterations observed in patients with non-specific episodic low back pain (compared to healthy volunteers), detected using several assessments: psychophysical and neurophysiological testing, imaging, and blood sampling, are dependent or independent of the presence and type of pain experienced at the time of investigation.

Reformer Pilates vs Conventional Physiotherapy in Chronic Low Back Pain

Non-specific chronic low back pain is one of the most prevalent musculoskeletal disorders worldwide and is associated with functional limitations and reduced quality of life. Exercise-based physiotherapy approaches are strongly recommended in clinical guidelines. Pilates exercises are frequently used due to their potential effects on core stability and movement control, while conventional physiotherapy remains a commonly applied treatment method. However, randomized controlled trials directly comparing these interventions are limited. This study aims to compare the short-term effects of reformer Pilates exercises and conventional physiotherapy on pain intensity, functional disability and health-related quality of life in individuals with non-specific chronic low back pain.