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103 active trials for Chronic Low Back Pain

Battlefield Acupuncture for Low Back Pain

The purpose of this study is to determine the effect of Battlefield Acupuncture (BFA) on outcomes for pain, sleep, and physical activity level in an active duty military sample with subacute or chronic lower back pain (LBP). BFA is a form of auricular acupuncture (AA) that has been implemented in many Department of Defense (DoD)/Veterans Affairs (VA) medical settings to alleviate acute or chronic pain. BFA uses five predetermined locations in a defined sequence to place semi-permanent needles in the ear. Subacute lower back pain is pain that has persistently lasted from four to twelve weeks. Chronic lower back pain is pain that lasts more than 12 weeks. Hypothesis 1: Participants with subacute or chronic LBP will have reduced pain using BFA as compared to placebo. Hypothesis 2: Participants with subacute or chronic LBP will have improved physical activity using BFA as compared to placebo. Hypothesis 3: Participants with subacute or chronic LBP will have improved sleep quality as compared to placebo. The secondary study aims are: To explore the effects of BFA two weeks following the treatment for LBP. Do positive outcomes appreciated with BFA persist over two weeks? What is the pain medication usage during and after intervention treatments? To explore the effectiveness of BFA on trunk flexion mobility and balance. Does pain reduction improve trunk flexion and balance? Does improved truck flexion mobility and balance contribute to increased physical activity?

Start: March 2018

Effect of Combined Morphine and Duloxetine on Chronic Pain

A double-blind, randomized, and placebo-controlled clinical study examining whether duloxetine, a serotonin and norepinephrine reuptake inhibitor (SNRI), could enhance opioid analgesia and reduce overall opioid use. Positive outcomes will help improve the overall effectiveness of clinical opioid therapy and reduce unnecessary opioid dose escalation.

Start: February 2018

Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain

Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.

Start: February 2020

Chronic Low Back Pain - Epiduroscopy Treatment

Retrospective analysis of patients with low back pain after epiduroscopic procedure

Start: December 2021

Cooperative Pain Education and Self-management

This study will test the effectiveness of using enhanced facilitation strategies on implementation of an automated Interactive Voice Response (IVR) system as a means to remotely deliver in-home self-management support to Veterans with chronic pain. The implementation intervention uses an enhanced facilitation approach paired with automated case finding and direct patient outreach to encourage uptake of Cooperative Pain Education and Self-management (COPES). A nested effectiveness study will measure pre-post differences in pain-relevant outcomes (pain intensity, physical functioning and physical activity). The investigators will use a stepped wedge cluster design in which clusters will be randomized to the timing of the introduction of enhanced COPES implementation. Investigators will assess the efficacy of the facilitation based implementation strategy by evaluating COPES uptake in the implementation settings.

Start: June 2018

Physical Activity on Neurophysiologic Gene Expression Profiles of Chronic Low Back Pain

This pilot project will provide an understanding of the contextual variables responsible for chronic low back pain. These variables include, genetic variation, pain sensitivity, reactivity, pain catastrophizing, perceived stress and kinesiphobia. The purpose is to understand the initial efficacy of self-management (SM) strategies on each of these contextual variables, in an effort to inform a personalized approach to managing chronic low back pain and its effect on improved health outcomes.

Start: September 2018

Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients

The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement. While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain. Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect. The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients. This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.

Start: June 2020

Intra-discal Injection of PRP for Low Back Pain

Low back pain (LBP) is the second cause of medical visits in France. Indeed, its incidence can vary between 60 and 90%. LBP is also the leading cause of disability in the adult population in France and in the rest of the world. Its evolution towards chronicity is observed in less than 8% of cases, but it is responsible for 85% of the medical costs. Degenerative disk disease (DDD) is a major cause of chronic LBP (> 40%). DDD can be characterized by peculiar Magnetic Resonance Imaging (MRI) features with a strong correlation between pain and inflammatory aspect of the disk, which result in the so-called active discopathy (AD) (Brinjikji et al. 2015). Modic classification based on MRI of the lumbar spine is considered as a reference. Type 1 Modic signal changes are characterised by a low-intensity signal on T1-weighted sequences and hyperintense signal on T2-weighted sequences, with gadolinium injection enhancement, corresponding to bone marrow oedema. Type 1 Modic is very rare in an asymptomatic population but may be found in 5% to 40% of chronic LBP patients underscoring its symptomatic involvement. No currently reference treatment is available for AD. PRP technology has recently been widely developed in osteoarthritis and tendon injuries. Therapeutic benefit of PRP has being evaluated. For instance, no randomized controlled trials (RCTs) have specifically evaluated the effect of PRP in AD (Modic 1 signal). The availability of PRP for intra- discal injection could become an innovative therapeutic option in humans, especially for AD forms where inflammatory process is clearly predominant. The objective of the study is to evaluate the 3-month efficacy on pain and function (by achieving 30% improvement in Oswestry Disability Index) of one intra-discal PRP injection versus placebo (saline solution) in subjects with LBP associated with AD lasting more than 3 months.

Start: November 2018

Determining the Prognostic Value of Continuous Intrathecal Infusion

The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes for treatment with intrathecal implantable devices. The investigators will compare the primary outcomes [changes in pain intensity score (NRS), patient global impression of change (PGIC)] before and after intrathecal infusion of an admixture of bupivacaine 0.625 mg/ml and fentanyl 1 mcg/ml versus normal saline. The study will include 36 patients with intractable chronic low back pain in the setting of lumbar post-laminectomy syndrome or vertebral compression fracture who failed conservative management and are considered candidates for IDDS. Prior to the implant, the patients will undergo an intrathecal prognostic infusion test with an externalized catheter. Baseline NRS pain scores will be assessed and documented on all patients upon admission to the preoperative area. An intrathecal catheter will be placed in the outpatient procedure suite at the appropriate level for target dermatomes. The needle entry point will occur in the upper lumbar spine and catheter tip will be placed in the lower thoracic spine, under local anesthesia with the patient awake and with minimal or no sedation. The intrathecal infusion will be started using an external pump once patient is in the PACU. The research component is to perform the intrathecal test with normal saline (inactive placebo solution) in addition to a test with fentanyl and bupivacaine (active solution). Patients will be randomly assigned to either Group I (continuous infusion of bupivacaine and fentanyl followed by saline) or Group II (continuous infusion of saline followed by bupivacaine and fentanyl). In PACU, patients will be started on an infusion rate of 0.5 ml/hr and titrated to pain relief greater than 50% of baseline or up to 0.8-1.0 ml/hr within 6-8 hrs after start of the infusion. A clinician blinded to the treatment arm will assess NRS and PGIC on the patients after approximately 12 hours. Assessment will include changes in pain intensity score at rest and upon ambulating or performing maneuvers that normally elicit patient's low back pain. A 4-6-hour washout period will be allotted with infusion of preservative-free normal saline at a rate of 0.2 ml/hr, after which the physician will document a return of the NRS to baseline before switching therapies.

Start: June 2017

E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain

The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients. Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months. A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain. The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.

Start: March 2020

MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain

This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain. Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.

Start: August 2018

Spinal Kinematics Variability

This study will test the within and between day variability of spinal kinematics and trunk muscle activity in healthy subjects and chronic low back pain patients during various daily-life activities.

Start: April 2018

Spinal Kinematics in Chronic Low Back Pain

Chronic low back pain (CLBP) is one of the most frequent causes for limitations in daily, leisure and work-related activities. Although alterations in spinal motor behavior were consistently reported in CLBP patients, it remains unclear how improvements in spinal motor behavior through rehabilitation treatment affect pain and disability. Psychological factors, such as pain-related fear, were suggested as a possible main cause of spinal motor behavior in CLBP and better understanding their relationships with kinematic and muscle activity alterations is required to enhance care, particularly physiotherapy. Therefore, this study will test CLBP patients before and after a 3 week rehabilitation program to test the hypotheses that: 1) improvements in spinal motor behavior (kinematics and trunk muscle activity) are associated with decreased pain and disability; 2) decrease in pain-related fear is associated with spinal motor behavior improvements.

Start: April 2018

The Enso Study for Chronic Low Back Pain

Enso is a portable device for the treatment of chronic and acute types of musculoskeletal pain. This study is being designed as a double-blinded, sham-controlled randomized clinical trial.

Start: November 2017

Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain

Older adults with chronic low back pain (LBP) are at a greater risk for disability, loss of independence, and lower quality of life. Experts agree that LBP is not a homogeneous condition, and treatments should differ based upon clinical presentation. One particular subgroup of older adults with chronic LBP are those that also have hip pain and muscle weakness; in addition, many of these individuals have limited and painful movement of the lumbar spine. Our past work indicates that all of these hip and lumbar spine impairments may contribute to worse physical function and greater disability, but the relative importance of each impairment is unclear. Thus, clinicians have limited evidence to draw on for treatment decisions, for this patient population. This randomized clinical trial is designed to explore two different interventions: one that addresses these hip issues (HIP+) and one that focuses more directly on the lumbar spine (SFR). We aim to recruit a sample of 180 older adults who have chronic LBP, as well as hip impairments (i.e. pain and muscle weakness). To ensure our findings are generalizable, the study will be conducted across three sites in different geographical regions: University of Delaware, University of Pittsburgh, and Duke University.

Start: November 2019

Turkish Version of Revised Neurophysiology of Pain Questionnaire

The Neurophysiology of Pain Questionnaire was first developed in English to test whether healthcare staff and patients could exactly understand pain neurophysiology. This questionnaire which contains 19 items was developed from the exam questions of students interested in post-graduate pain medicine. Catley et al. (2013) investigated the psychometric properties of the modified Neurophysiology of Pain Questionnaire with a few word differences from the original version by conducting a rash analysis on 300 patients with chronic spinal pain. Acceptable internal consistency and test-retest reliability of the questionnaire were recorded. However, it was stated that 7 items negatively affect psychometric properties of the questionnaire. As a result, the author concluded that the questionnaire had sufficient psychometric properties for use in chronic spinal pain subjects, but further studies were needed. The Neurophysiology of Pain Questionnaire was used to measure a knowledge about pain in different studies. The validity and reliability studies of the Dutch, French and Brazlian Portuguese versions of the Neurophysiology of Pain Questionnaire were conducted in the literature. The aim of our study was to translate the Revised Neurophysiology of Pain Questionnaire into Turkish language and to investigate its psychometric properties.

Start: November 2019

Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain

Protocols in which pain neuroscience education is combined with physical exercise have shown recently greater effectiveness in the treatment of low back pain in comparison to protocols based only on one of the two approaches. The professional caregiver has a high incidence of low back pain related to the specific aspects of this collection with the low physical condition, the typical tasks performed and other psychosocial aspects. Individual characteristics of these caregivers may condition the effectiveness of the therapy as well as demographic aspects or the alliance between patient and physiotherapist. The aim of this study is to determine the influence of certain health determinants on the effectiveness of a therapy that combines pain neuroscience education and motor control training from a neurocognitive perspective on chronic low back pain in a population of professional caregivers in Bages, analyzing the reduction of low back pain, the improvement of functionality, the reduction of muscle movement and the improvement of muscle coordination. It will be a quasi-experimental pre-post design, prospective, with a control group, lasting 3 months. The intervention will be performed using a sample of professional caregivers, and the data will be collected before the intervention, at the end of the intervention, and 3-6 months after the intervention. Pain, functionality, conducts of fear/avoidance, and muscular coordination will be analyzed

Start: December 2019

Chronic Pain, Couples, & Physical Activity

Chronic pain affects more than 50 million adults in the United States (Dahlhamer, Lucas, Zelaya, Nahin, Mackey, DeBar et al., 2018) and is estimated to cost the nation more than $560 billion dollars each year (Gaskin & Richard, 2012). Regular physical activity is widely recognized as essential for maintaining health for all individuals (US Department of Health and Human Services, 2018), but is particularly important for individuals with chronic pain (ICPs) as physical activity can prevent further deconditioning and may even improve pain outcomes (e.g., CDC, 2018). Previous literature has shown that certain categories of partner behaviors (e.g., solicitous, punishing, distracting) are associated with different health outcomes for ICPs (e.g., Cano, Leonard, & Johansen, 2006), and recently researchers have begun examining partner behaviors through the lens of Self-Determination Theory, specifically looking at the effects of autonomy support from a spouse on physical activity among ICPs (e.g., Uysal et al., 2017). Partner autonomy support has been positively associated with physical activity levels (Martire et al., 2013) and better health outcomes (Uysal et al., 2017), but no studies to date have explored what factors predict whether or not a partner will use an autonomy supportive interpersonal style (as opposed to a controlling interpersonal style) with the ICP. Similarly, more research is needed on the mechanisms by which autonomy support promotes positive outcomes for ICPs. Though receiving autonomy support has been linked to increased physical activity and improved mental health, no studies have yet tested the full Self-Determination Theory model as one possible explanation of the link between this form of partner support and desirable health outcomes. In particular, it is important to understand the ICP's perspective on how partner autonomy support influences need satisfaction and autonomous motivation as possible mediators between autonomy support and ICP physical activity. Furthermore, little research has explored other need supportive behaviors or their need frustrating counterparts. The current study will not only provide greater understanding of autonomy support, but will also expand the literature regarding these other need supportive and need thwarting behaviors. Lastly, given the value of need supportive behaviors from one's partner, it is essential to evaluate how partner perceptions of those need supportive behaviors align with ICP's perceptions of those behaviors. Any need support a partner provides is likely moderated by the ICP's perception of that support.

Start: April 2019

Effectiveness of Ultrasound Guided Platelet Rich Plasma Injections in the Sacroiliac Joint

This prospective study will be quantitatively analyzing the effectiveness of platelet-rich-plasma (PRP) injections into the sacroiliac (SI) joint in relieving sacroiliitis and low back pain originating from the SI joint. The effectiveness of PRP injections on joint pain has been well studied in the knee and shoulder. PRP injections are performed on the SI joint commonly, but there is little research documenting their effectiveness when compared to other interventions. This study will be a small pilot study to aid in closing this knowledge gap. Additionally, these injections will be performed under ultrasound guidance. Ultrasound has been proven to be of equal reliability to fluoroscopy and has the advantage of shorter time to administer and no radiation. There will be one arm to this study. The data collected will be compared to existing studies on corticosteroid SI joint injection. The experimental arm consists of the PRP injection. The PRP will be injected into the joint using the exact same technique via physical exam, special tests, and ultrasound guidance as performed in our previous studies. The outcomes will be measured with the Numeric Rating Scale for Pain (NRS) and the Oswestry Disability Index (ODI) prior to the injection, immediately post-injection, 2 weeks, 4 weeks, 3 months, 6 months, 9 months, and 1 year post-injection. The investigators hypothesis is, "Platelet-Rich Plasma Injections in the Sacroiliac Joint using ultrasonography in conjunction with physical examination and Point of Maximal Tenderness will produce statistically significant pain relief for more than 3 months as measured by the Numeric Rating Scale for Pain (NRS) and Oswestry Disability Index (ODI)."

Start: May 2017

Pain Neuroscience Education for Depression

This study will look at the effects of Pain Neuroscience Education on a Depression outcome tool in patients with chronic low back pain.

Start: June 2019