Clinical Research Directory

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.

Hybrid mHealth for Low Back Pain

The goal of this clinical trial is to evaluate whether adding a WhatsApp-based AI chatbot to standard physiotherapy and psychological care can improve self-management and outcomes in adults aged 18-65 with chronic low back pain (CLBP). The main questions it aims to answer are: Is it feasible and acceptable to use a WhatsApp-based AI chatbot as an adjunct to standard care in adults with CLBP? Does the addition of an AI chatbot improve pain, disability, mental health, and quality of life compared to standard care or digital self-management alone? Researchers will compare three groups: Standard care (face-to-face physiotherapy and education) with the AI chatbot, Standard care alone, AI chatbot alone. Participants will: Attend weekly sessions for 8 weeks (depending on group assignment, this may be face-to-face, digital, or both); Use a WhatsApp-based AI chatbot for personalized exercise and self-management support, gamification, and optional peer-support; Complete questionnaires and provide feedback on pain, function, mental health, and program usability at several time points; Receive onboarding and privacy safeguards for digital components.

Core Muscle Training in Patients With Chronic Mechanical Low Back Pain

The goal of this study is to train core muscles in patients with chronic low back pain, the researchers will compar between the effect of suspension exercise core muscle training and pressure biofeed back core muscle training

Therapeutic Exercise Plus Pain Neuroscience Education for Chronic Low Back Pain

\### What is this study about? This study looked at whether adding \*\*pain neuroscience education (PNE)\*\* to standard therapeutic exercise helps people with chronic low back pain who are afraid of moving (a condition called \*kinesiophobia\*). \### Why does it matter? Chronic low back pain is the leading cause of disability worldwide. Many people with chronic back pain develop fear of movement, which makes them avoid exercise and can slow down recovery. While exercise is the recommended first-line treatment, fear of movement often reduces how much patients benefit from it. Pain neuroscience education is a talking therapy that helps patients understand that chronic pain is not always a sign of tissue damage - it often involves the nervous system becoming overly sensitive. The idea is that changing how patients think about pain may reduce their fear and help them engage more fully in exercise. \### What did the researchers do? Patients with chronic low back pain and high fear of movement were randomly assigned to two groups * \*\*Group 1:\*\* 8 weeks of therapeutic exercise alone * \*\*Group 2:\*\* 8 weeks of therapeutic exercise \*\*plus\*\* two pain neuroscience education sessions (at the start and at week 4) * Patients were assessed at \*\*baseline, 8 weeks, and 24 weeks\*\* (6-month follow-up) * Measures included: fear of movement (TSK-17), pain intensity (NRS), disability (RMDQ), pain catastrophizing (PCS), and central sensitization symptoms (CSI) * Brain scans (resting-state fMRI) were taken before and after the intervention to explore potential brain-behavior links

Treatment Validation for Myofascial Pain

The goal of this clinical trial is to see if a body test called the NUN biomarker can track changes in chronic low back pain after dry needling and predict who will feel better. This study is for adults with chronic low back pain from muscle pain (Myofacial Pain). The main questions are: * Does the biomarker drop when pain improves? * Can it predict who benefits most? * Do higher starting levels mean better results with real dry needling? Investigators will compare real and fake (sham) dry needling using ultrasound, muscle pressure tests, and pain reports before and after treatment.

Pain Assessment Through Integrated Neurophysiology and Multidimensional Profiling

This observational case-control study aims to investigate the central neurophysiological mechanisms underlying non-specific chronic low back pain (CLBP) with neural mechanosensitivity, with wearable Optically Pumped Magnetometers Magnetoencephalography (OPM-MEG). The study evaluates brain activity dynamics at rest and during controlled movement-evoked pain. Additionally, it explores the relationship between cortical processing markers and multidimensional biopsychosocial profiles (including pain intensity, kinesiophobia, catastrophizing, sleep quality, and functional disability) and gait adaptaions in adults with CLBP aged 18 to 45 compared to healthy pain-free controls.

Pain Science Education and Graded Exposure for Chronic Low Back Pain

Chronic low back pain can affect daily activities and may be influenced by how people understand pain, their fear of movement, and their responses to stressful or uncertain physical activities. This clinical trial will evaluate whether a 6-week program combining pain science education with graded exposure to movement is more effective than usual physical therapy for adults with chronic low back pain. Participants will be randomly assigned to one of two groups: pain science education combined with graded exposure to movement, or usual physical therapy. The study will assess changes in pain, disability, fear of movement, and pain-related thoughts. It will also examine physiological responses to stress and muscle activity while participants perform a lifting task. The study aims to determine whether combining education about pain with gradual exposure to feared movements can improve clinical outcomes, physiological responses to stress, and motor performance in people with chronic low back pain.

TECAR Therapy in Chronic Back Pain

The goal of this clinical trial is to learn whether adding high-intensity electromyostimulation (Hi-EMS) to capacitive and resistive electric transfer (TECAR) therapy improves pain and functional performance in adults with chronic nonspecific low back pain. The main questions it aims to answer are: * Does adding Hi-EMS to TECAR therapy reduce low back pain at rest? * Does adding Hi-EMS reduce pain during the Five-Times-Sit-to-Stand Test? * Does adding Hi-EMS improve pressure pain threshold and performance on the - Five-Times-Sit-to-Stand Test? Researchers will compare TECAR therapy delivered with Hi-EMS to TECAR therapy delivered without Hi-EMS. Participants will: * Receive both treatment conditions in a randomized order * Wait one week between treatment sessions * Receive 10 minutes of capacitive electrical transfer followed by 10 minutes of resistive electrical transfer during each session * Receive Hi-EMS during the 10-minute resistive electrical transfer phase in one of the sessions * Complete pain, pressure pain threshold, and functional performance assessments immediately before and after each session

Melatonin for Patients With Chronic Low Back Pain

Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain. The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.

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.

Pain Phenotypes in Individuals With Chronic Low Back Pain

This observational cross-sectional study aims to determine pain phenotypes in individuals with chronic low back pain (CLBP). Participants will be classified according to a mechanism-based clinical pain phenotyping algorithm as having nociceptive, neuropathic, nociplastic, or mixed pain. Clinical history, quantitative sensory assessment, pain characteristics and distribution, central sensitization-related symptoms, disability, health-related quality of life, and pain catastrophizing will be assessed. In addition, the intra-rater and inter-rater reliability of the pain phenotyping algorithm will be investigated, and the clinical characteristics of different pain phenotypes will be compared.

Combined and Aquatic Exercise in Chronic Low Back Pain

The goal of this randomized clinical trial is to evaluate the effects of a combined aquatic- and land-based exercise program, as well as an aquatic-exercise program, compared with a control group receiving home-based exercise, on pain, disability, and functional capacity in adults with CLBP. Secondary objectives include examining the effects on fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility. The main question it aims to answer is: "Which type of exercise program is most effective at improving pain, disability, functional capacity, fear of movement, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility in adults with chronic low back pain?". Participants will perform an aquatic-based exercise program (aquatic group), a combined aquatic and land-based exercise program (aquatic and land group), or a land-based exercise program (home group). Researchers will compare groups to find any differences in pain, disability, functional capacity, kinesiophobia, anxiety and depression, quadriceps and hand-grip strength, and lumbar mobility.

Impact of the Receptive Music Intervention Tool (MUSIC CARE©) on Changes in the Functional Abilities of Patients With Chronic Low Back Pain

Brief Summary The goal of this clinical trial is to learn if MUSIC CARE©, a music-based therapy tool, can improve the physical abilities of people with chronic low back pain (back pain that lasts more than 3 months). The main questions it aims to answer are: Does MUSIC CARE© help participants better perform their daily activities? Does MUSIC CARE© lower the fear of movement in participants? Does MUSIC CARE© help participants return to work? Why this study? Chronic low back pain is a leading cause of disability and absence from work. Physical rehabilitation is the recommended treatment. However, many participants develop a fear of movement. This fear slows down their recovery and limits the benefits of rehabilitation. MUSIC CARE© is a digital music tool. It uses specially designed music to help participants relax and feel less pain. Researchers believe that using MUSIC CARE© before rehabilitation sessions may help participants move more freely and recover better. How does the study work? Researchers will compare two groups of participants: Group 1: follows a standard rehabilitation program with MUSIC CARE© Group 2: follows a standard rehabilitation program without MUSIC CARE© This comparison will show whether MUSIC CARE© brings added benefits. Participants will: Take part in a rehabilitation program for 5 to 6 weeks Use MUSIC CARE© before each therapy session (Group 1 only). Complete questionnaires about their pain, fear of movement, and ability to perform daily activities. Be followed for 6 months after the program ends, including an assessment of their return to work. What could this study change? If results are positive, this study could confirm that MUSIC CARE© is a useful non-drug tool to support rehabilitation for people with chronic low back pain. It could help bring this approach into standard care programs, with no additional medication.

Comparing Non-Medicine Strategies for Improving Low Back Pain

The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems. What Will Happen: Veterans in this clinical trial will be randomly placed into one of two groups. ENCompaSS group (intervention): * Have at least three phone calls with a trained clinician over about 12 weeks * Watch short online videos about managing pain * Complete surveys before the study and again at 2, 4, 6, and 12 months Usual Stepped Care group: * Will continue with regular care * Complete the same surveys at the same time points

Effects Of Vacuum Controlled Static Versus Vacuum Controlled Dynamic Dry Cupping On Pain, Range Of Motion And Disability Among Patients With Chronic Low Back Pain

This randomized controlled clinical trial aims to compare the effects of vacuum-controlled static dry cupping and vacuum-controlled dynamic dry cupping on pain intensity, lumbar range of motion, and functional disability in patients with chronic low back pain. Participants will be randomly assigned to two groups receiving either static or dynamic dry cupping along with conventional treatment. The outcomes will be assessed to determine which cupping technique is more effective in improving pain, mobility, and functional ability in individuals with chronic low back pain. \[Time Frame: Measured at baseline (pre-intervention) and after 6 weeks (post-intervention completion).

Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome

This study will evaluate the clinical and biological effects of acupuncture for chronic low back pain associated with myofascial pain syndrome (MPS). In this randomized, participant- and assessor-blinded clinical trial, 64 adults with chronic low back pain due to MPS will be assigned to receive either true acupuncture or sham acupuncture for eight weeks. Participants will undergo total-body positron emission tomography/computed tomography (TB-PET/CT) imaging and complete standardized pain and functional questionnaires at baseline and after treatment. The study will evaluate whether acupuncture improves pain and function compared with sham treatment and whether TB-PET/CT imaging can detect changes in myofascial tissue metabolism and perfusion that correspond with clinical outcomes.

Biopsychosocial Model-based Care Versus Routine Physical Therapy in Chronic Back Pain

Chronic low back pain (CLBP) is a multifactorial condition influenced by physical, psychological, and social factors. Conventional physical therapy primarily targets biomechanical impairments, often neglecting psychosocial contributors that perpetuate chronic pain and disability. This randomized comparative clinical trial aims to evaluate the effectiveness of Biopsychosocial (BPS) model-based care versus routine physical therapy on pain, disability, psychosocial outcomes, and inflammatory response among adults with CLBP. A total of \_\_\_ participants with CLBP (≥12 weeks) will be randomly allocated into two groups: Routine Physical Therapy Group - receiving baseline hot pack and TENS, stretching (hamstring, gluteal, iliopsoas, and lumbar extensors), and strengthening/stabilization exercises (planks, abdominal bracing, gluteal isometrics, and bridging). BPS Model-Based Care Group - receiving the same baseline treatment plus Maitland mobilization (Grade I-II central PA), sciatic nerve slider, abdominal bracing, graded functional activity, cognitive behavioral therapy (CBT), pain neuroscience education (PNE), guided imagery, and group-based functional exercise therapy. Primary outcome measures include Pain Self-Efficacy, Oswestry Disability Index (ODI), and C-Reactive Protein (CRP). A secondary variable, Perceived Social Support, will assess the social component of recovery. This study hypothesizes that the BPS model-based care will produce superior improvements in pain self-efficacy, functional disability, and inflammatory markers compared to routine therapy, supporting the integration of biopsychosocial rehabilitation in chronic low back pain management.

Brain Mechanisms Supporting Cannabis-induced Pain Relief

Chronic low back pain is a common and disabling condition that affects millions of people in the United States. Many people with chronic low back pain do not get enough relief from current treatments. Cannabis may help reduce pain, but researchers do not fully understand how it affects the brain in people with chronic pain. The purpose of this study is to examine how inhaled cannabis changes brain activity and reduces pain in people with chronic low back pain. Results from this study may help researchers better understand how cannabis works for pain and support the development of improved pain treatments.

Virtual Reality Based High-intensity Interval Training in Chronic Low Back Pain

One of the most prevalent causes of pain on a global scale is chronic musculoskeletal pain. Low back pain is a prevalent manifestation of chronic musculoskeletal pain. There are a wide vary of no pharmacologic treatment for chronic pain. From a physiotherapy perspective, the chronic pain management should be oriented towards increasing the self-management of people with chronic pain. The management components in question are therapeutic exercise and education. High-intensity interval training (HIIT) is a novel therapeutic exercise strategy that has been shown to reduce pain and disability in chronic low back pain. It is a hopeful strategy to enhance motivation to treatment. Pain neuroscience education (PNE) has also been demonstrated to enhance pain and disability in chronic low back pain. Finally, virtual reality (VR) has been demonstrated to be effective in the chronic low back pain management. Despite the benefits mentioned in these three therapies being isolated, there are no studies that have compared VR-based HIIT (VR-HIIT) with PNE in chronic low back pain. The use of these interventions may increase the intervention benefits. The investigators hypothesise that VR-HIIT with PNE can reduce pain intensity, enhance fear of movement and improve motivation for treatment in chronic low back pain. Therefore, the aim of this study is to evaluate the effects of VR-HIIT with PNE in chronic low back pain.

Mindfulness-Based Therapy for Chronic Low Back Pain in Office Workers

This study evaluated whether a mindfulness-based therapy program could reduce pain severity in office workers with non-specific chronic low back pain. The study included staff members of Dokuz Eylul University aged 20 to 59 years who had low back pain for at least three months and worked at a desk for more than four hours per day. Participants were randomly assigned to either a mindfulness-based therapy group or a control group. The mindfulness-based therapy group attended online group sessions once a week for four weeks. The sessions included breathing awareness meditation, body scan meditation, self-compassion meditation, and chair yoga practices. Participants in the control group continued their usual medical care during the study period. The primary outcome of the study was pain severity, assessed using the Visual Analogue Scale. Secondary outcomes included physical activity level, disability related to low back pain, anxiety symptoms, quality of life, and mindfulness level. Participants were evaluated at baseline, Week 4 (end of intervention), Week 16 (3-month follow-up), and Week 28 (6-month follow-up).

Exercise-Based Strategies for Chronic Back Pain

This randomized, controlled, five-arm, parallel-group trial will evaluate the effects of 8 weeks of supervised resistance training and developmental position-based exercise, with or without real-time non-invasive intra-abdominal pressure biofeedback, in adults aged 40 to 60 years with chronic low back pain. The trial will compare supervised gym-based agonist-antagonist paired set resistance training with OHMTRACK, supervised gym-based resistance training without OHMTRACK, supervised physiotherapy-based developmental exercise with OHMTRACK, home-based developmental exercise with OHMTRACK, and an active control condition. Primary outcomes will assess changes in pain and physical function after the intervention. Secondary outcomes will include neuromuscular coordination, postural stabilization, cardiovascular, respiratory, metabolic, behavioral, feasibility, and follow-up outcomes.

Effects of Vertebral Axial Loading Walking Combined With Core Stabilization Exercises in Individuals With Chronic Low Back Pain

Chronic low back pain is a common musculoskeletal condition persisting for more than three months and is associated with pain, functional limitations, impaired balance, altered proprioception, reduced trunk muscle performance, and decreased quality of life. Previous studies have demonstrated that individuals with chronic low back pain exhibit altered sensory input from spinal structures and impaired neuromuscular control, which may contribute to persistent pain and movement dysfunction. Although exercise-based physiotherapy approaches, particularly core stabilization exercises, are widely recommended and effective in the management of chronic low back pain, sensory deficits related to balance, proprioception, and body awareness are often insufficiently addressed in conventional rehabilitation programs. Vertebral axial loading walking training is a functional rehabilitation approach involving slow, controlled walking under gentle vertical loading applied along the spinal axis. This intervention is thought to enhance afferent sensory input from spinal mechanoreceptors, potentially improving balance control, proprioception, and motor coordination. This randomized controlled study aims to investigate the effects of adding vertebral axial loading walking training to a standard core stabilization exercise program on pain intensity, balance, proprioception, trunk muscle strength and endurance, and body awareness in individuals with chronic low back pain.

Combining Brain Stimulation and Physiotherapy for the Management of Chronic Low Back Pain

Chronic low back pain (CLBP) is a major health challenge in Canada, leading to substantial disability and socioeconomic burden, particularly among Veterans. In military Veterans, LBP is the most common chronic pain condition. Conventional interventions have limited effectiveness. The refractoriness to interventions suggests that specific CLBP mechanisms may be missed by current treatments, prompting a shift towards psychologically informed approaches which aim to address emotional and cognitive factors alongside biomedical aspects. The integration of these concepts into physiotherapy is called psychologically informed physiotherapy (PiP). Despite promising results of PiP from randomized controlled trials, residual pain and disability often persist in Veterans. Non-invasive brain stimulation, such as repetitive transcranial magnetic stimulation (rTMS), may enhance the effectiveness of PiP by modulating cognition, emotion, and pain. This proposal seeks to determine whether non-invasive brain stimulation can enhance the effects of PiP.

Effects of PEMM in Chronic Low Back Pain Women With Urinary Incontinence

Urinary incontinence (UI), Chronic low back pain (CLBP) in women are prevalent and often coexist. Multiple conditions when coexist, it leads to reduced Quality of life in turn causing physical and mental impairment. Musculoskeletal structures and fascial restrictions is one of the attribute to the coexistence of urinary incontinence and chronic back pain in women. External myofascial mobilization (EMM) with core exercises have been proven beneficial for conditions in males that is caused by musculoskeletal and fascial structures. However there are limited research which proves the effect of EMM in conditions involving musculoskeletal and fascial structures . Therefore, the aim of the study is to find the effect of MFTs in reducing the disability in women with CLBP and UI PRIMARY OBJECTIVE To evaluate the effectiveness of PEMM treatment in reducing disability, pain and improving mental health in women with CLBP and UI Study design : Simple randomization Sampling method: Simple Random sampling Random numbers will be generated in Excel, then random numbers will be presented in a concealed envelope for the participants to choose Sample Size : 130 (Experimental 65, Control 65) Sample size was determined using expected effect size i.e., mean change in the primary outcome variable disability index reported in the recent research study . With effect size (change in the disability index score) 3.5 and standard deviation of the change in the outcome 6.45, statistical power 80% and level of significance 5%, the required sample size would be n=55 participants in each group. However, to accounts for multiple secondary outcome measures, possible dropouts and non-response it would be good to increase an additional 20% in calculated sample size i.e., a total of 130 participants (65 participants in each group) will be included in this study. The following sample size equation was used to determine adequate sample size:n = \[2 (Z?/2 + Z?)2 \* ?2\] / (m1-m2)2 Where Z? and Z? are the values standard normal variate e.g., at 5% level of significance Z?/2 = 1.96, and with 80% power the value of Z?= 0.84; ? is the polled Standard deviation and m1 and m2 are the mean outcome values s in group 1 and group 2 respectively. Blinding: Single blinding: patient will be blinded to the group allocation. The assessor is blinded to the treatment Material and tools : Theragun - Theragun Elite, 20 V, Myofascial tools - foam roll, foam ball, Questionnaires - SF 3642,43,44, Oswestry Low back pain questionnaire (ODI)45 and The International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF)46 PROCEDURE In the course of the study the total number of patients referred to physiotherapy department with LBP will be interviewed to identify patients with or without UI having LBP. The data obtained from this will be recoded as prevalence in results. The documents of the patients having LBP with UI will be reviewed to check who fulfills the inclusion criteria. All who meets the inclusion criteria will be approached face to face with the aim of the study. Informed consent form will be given to patients who are volunteering to participate in the study. The data of the participants who do not wish to participate in the study will also be recorded. The participants who have consented to participate in the study will be then assessed. Since the participants has UI she will be directed to a Urologist for an assessment. After urologist assessment, patients will be randomly allocated to experimental and control groups. Random allocation will be administered by the random numbers generated and will be presented in a concealed envelope for the participants to choose. 1st week, the demographic data and Outcome measure of pain, SF36, ODI, ICIQ-UI-SF will be recorded (1st time) on the day of assessment. The outcome measures will be printed on paper and will be given to the patients to fill up with a pen, all questionnaires are self reported outcome measures. Treatment will commence a week after, where experimental group will undergo PEMM therapy with strengthening for 6 weeks duration and the control group will have conventional symptomatic pain treatment with strengthening (2nd to 7th week). Treatment will be given for 6 weeks (1 sessions in a week). The treatment day may vary any day between 4th and 7th day post one session. After 6 sessions of treatment, patient will be advised HEP (Home exercise program) to continue at home. Reassessment will be done on the 8th week where the outcome measures of pain, SF36, ODI, ICIQ-UI-SF will be recorded. Participants will be educated and advised regarding HEP. Exercises will be taught to the patient by explanation, demonstration, teach-back method, and printed sheet of exercise. Compliance to HEP will be recorded before final Outcome measure