Clinical Research Directory

Erector Spinae Plane Block Versus Trigger Point Injection for Chronic Thoracic Myofascial Pain

Chronic thoracic (mid-back) pain can be difficult to treat, and there is limited evidence to guide the use of injection therapies for pain arising from muscles and surrounding soft tissues. Two commonly used treatments are trigger point injections (TPI) and erector spinae plane (ESP) blocks, but no studies have directly compared their effectiveness for chronic thoracic myofascial pain. The purpose of this study is to compare pain relief, physical function, emotional well-being, patient satisfaction, and safety following treatment with either an ESP block or TPI. Participants will be randomly assigned to receive one of the two treatments. Researchers will follow participants for up to 12 weeks after the procedure and collect information through questionnaires and pain assessments.

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.

Hormones, Outcomes, and Pain Pathways in Exercise Study

The goal of the proposed project is to evaluate a mechanical intervention (sports bras designed specifically for full busted women) to alleviate neck, shoulder, arm, and back pain in full-busted women and investigate the contribution of non-mechanical pathways associated with this type of pain in women. Specifically, the investigators will investigate how sex-hormones, inflammation, and remapping of specific regions of the brain contribute to the manifestation of neck, shoulder, arm, and back pain in full-busted women across the lifespan.

The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)

VIA Disc NP Registry 3.0

Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

Partners4Pain & Wellbeing: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain

The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.

Development of STEPPT

This 6-month pilot study aims to assess the feasibility, acceptability, and estimate effect sizes of the pilot STEPPT intervention for addressing ethnic disparities in physical therapy referrals and adherence between Hispanic and Non-Hispanic White patients with spine pain. Feasibility and acceptability will be assessed based on the extent to which the pilot clinic implements all components of the intervention appropriately, feedback from clinic staff during implementation of the intervention, and feedback from patients during post-intervention interviews. The investigators anticipate that the intervention will be both feasible and acceptable. Feedback from patients and clinic staff will be used to inform intervention modifications for a larger clinical trial. Effect sizes for the pilot STEPPT intervention (intervention) in comparison to standard care (control) will be assessed by evaluating changes in ethnic disparities (Hispanic vs. Non-Hispanic White) in physician referral to physical therapy and patient adherence to physical therapy referral for the treatment of spine pain before and after implementation of the pilot STEPPT intervention. In comparison to standard care, the investigators expect STEPPT to reduce ethnic disparities in referral and adherence outcomes.

CARES (Comprehensive Analgesic, Recovery, and Education Support) for Surgery Trial

The goal of this clinical trial is to learn whether a combined behavioral and pharmacologic intervention can help reduce opioid use, improve pain recovery, and prevent opioid misuse after surgery in adults undergoing elective surgery. The study includes adults aged 18 to 75 who have a history of long-term opioid use, defined as having access to opioids for 60 or more days within the 180 days before surgery. The main questions it aims to answer are: * Does Motivational Interviewing with guided opioid tapering plus tizanidine (MI-Opioid Taper + Tizanidine) help participants return to their preoperative opioid use level or stop opioids faster than Enhanced Usual Care (EUC)? * Does the intervention reduce the time to pain resolution and decrease the likelihood of opioid misuse after surgery compared to EUC? Researchers will compare MI-Opioid Taper + Tizanidine to MI-Opioid Taper with placebo and to EUC to see whether the intervention improves postoperative opioid and pain outcomes. Participants will: * Complete a phone assessment and baseline survey before surgery * Be randomly assigned 7-13 days after surgery to one of three groups: * MI-Opioid Taper + tizanidine (MTT) * MI-Opioid Taper + placebo (MTP) * Enhanced Usual Care (EUC) * Complete brief weekly phone or video visits with a study clinician for 6 weeks starting 14 days after surgery * Take a study medication (tizanidine or placebo) three times daily for 5 weeks (MTT and MTP groups only) * Complete weekly online surveys for 6 months, followed by monthly surveys until 12 months after surgery to track pain, opioid use, and related outcomes

Immune Response During the Conservative and Minimal Invasive Treatment of Pain Caused by Lumbar Disc Herniation

Bulging of the intervertebral disc in the lumbar part of the spine is one of the most common degenerative changes of the spine in the elderly population, which causes various symptoms such as radicular pain. Possible mechanisms of radicular pain are mechanical compression of the intervertebral disc on the nerve and sterile local inflammation caused by proinflammatory factors. Depending on the degree of diagnosis, if conservative treatment is not successful, then treatment is focused on minimally invasive methods such as epidural steroid injection (ESI). The achieved neural blockade is believed to alter or interrupt nociceptive input, reflex mechanisms induced by afferent fibers, self-sustaining neuronal activity, and central neuronal activity. On the other hand, corticosteroids reduce inflammation by inhibiting pro-inflammatory mediators and causing a reversible local anesthetic effect. The aim of the research is to measure the concentrations of pro-inflammatory and anti-inflammatory cytokines and metallopeptidases in the serum before physical therapy, i.e. ESI, and two weeks and three months after the start of said therapies, then to examine the clinical status, intensity of pain and limitations of movement associated with pain in all three time points in order to determine the treatment outcomes after the mentioned therapies and examine the possible association of cytokine concentrations with the treatment outcomes and, last but not least, to determine the degree of the patient's psychophysical condition and quality of life before the mentioned therapies, two weeks and three months after the start of the therapies in order to examined possible associations with treatment outcomes and changes in cytokine and metallopeptidases concentrations.

A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants

The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50 years. The primary research question is: Does treatment with the OsteoPearl Biological Allograft reduce pain in men and women aged ≥50 years undergoing vertebral compression fracture procedures? Participants who are already undergoing kyphoplasty or vertebroplasty as part of standard clinical care for vertebral compression fracture will complete a pain questionnaire over a 30-day follow-up period.

Testosterone Replacement to Alleviate Pain in Postmenopausal Women (TRAPP Trial)

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, physical function and quality of life when compared with placebo in women with chronic back pain treated with opioids who have low testosterone.

Exploring Multimorbidity in Patients With Spinal Pain

Spinal pain is frequently accompanied by other chronic conditions (multimorbidity) and the predicted rise in multimorbidity prevalence emphasizes the need for studies to understand its impact on patients with chronic pain conditions. Therefore the aims of the two studies are to: Work package 1 - Determine prevalence of multimorbidity among patients with spinal pain referred to hospital outpatient clinics. Examine associations with relevant health-related factors and cover the significance of multimorbidity in the diagnostic process, referral patterns and healthcare utilization. Work package 2: Examine the association between treatment burden arising from multimorbidity and patient prognosis in structured rehabilitation. Across both work packages data will be derived from individuals initially referred to the Department of Rheumatology at Aalborg University Hospital (AaUH) or the Medical Spine Clinic in Silkeborg (MSCS).

Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)

The goal of this observational intervention study is to evaluate the impact of a multidisciplinary active coping program for chronic back pain in adults referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche. The main questions it aims to answer are: * Does the program improve physical function, measured through gait speed, balance, and chair stand tests? * Does it reduce pain-related psychological factors such as kinesiophobia, catastrophizing, anxiety, and depression? * Does it improve quality of life and sleep quality, and reduce analgesic medication use? Participants will attend group sessions on pain neuroscience education, followed by sessions on healthy habits, nutrition and sleep hygiene and group psychological intervention focused on emotional wellbeing tools, and will complete therapeutic exercise sessions over the course of the program. They will also complete validated questionnaires and physical assessments at three timepoints: at baseline, at the end of the program, and at a 6-month follow-up.

Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain

The goal of this clinical trial is to learn which treatment works better for veterans with chronic neck or back pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain). The main questions the study aims to answer are: 1. Which treatment works better for lowering pain: PRT, CBT, or usual care? 2. How do the effects of PRT compare with CBT and usual care in terms of pain relief and other factors such as emotional functioning, quality of life, anxiety, and pain medication use? Participants will: 1. Be randomly assigned to receive either PRT, CBT, or usual care. 2. Complete questionnaires about their pain and health. 3. If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.

Conventional vs Pulsed RF in Coccydynia

The aim of this study is to prospectively evaluate the effects of pulsed and conventional radiofrequency ablation of the ganglion impar on pain, quality of life, and sleep quality in patients with refractory coccydynia, and to determine whether one treatment is superior to the other.

Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

Pain Intervention With Needling: Pilot Of Integrated Neuromodulation Techniques

The study's purpose is to determine the effects of three different dry needling sessions on pain and quality of life for those with chronic low back pain. Dry needling is a therapeutic procedure in which a very thin, monofilament needle is inserted through the skin to reach a target tissue like a muscle to help reduce pain, improve muscle activation, and increase blood flow. Dry needling has also been shown to improve nervous system function.

Neck and Low Back Pain in Physical Therapy Students at The University of the West Indies, Mona, Jamaica

The purpose of this study is to determine the prevalence of neck and low back pain among physical therapy students enrolled at The University of the West Indies, Mona. It also aims to assess students' knowledge, attitudes, and practices regarding spine health and to evaluate the effectiveness of an eight-week standardised spine-specific exercise programme in reducing musculoskeletal pain and improving functional status among those reporting symptoms. The study will be conducted in two phases, beginning with a descriptive cross-sectional assessment of prevalence, followed by a prospective randomised controlled trial in which students experiencing neck and/or low back pain will be allocated to either a spine-specific exercise intervention group or a non-spine-specific exercise control group for comparative analysis of outcomes.

The Prevalence of Neck and Low Back Pain in FMSTRC Staff At the UWI Mona

The purpose of this study is to determine the prevalence of neck and low back pain among full-time staff at the Faculty of Medical Sciences Teaching and Research Complex (FMSTRC), The University of the West Indies, Mona. It also seeks to assess staff members' knowledge, attitudes, and practices regarding spine health and to evaluate the effectiveness of an eight-week standardised spine-specific exercise programme in reducing musculoskeletal discomfort among those experiencing neck and low back pain. The study will be conducted in two phases using a descriptive cross-sectional design followed by a prospective randomised controlled trial, in which participants reporting pain will be allocated to either a spine-specific exercise intervention group or a non-spine-specific exercise control group for comparative analysis of outcomes.

Low Back and Neck Pain in Nursing Students at The University of The West Indies

The purpose of this study is to identify the prevalence of neck and low back pain in nursing students enrolled at the University of the West Indies, Mona; to assess their knowledge, attitude and practice of good spine health and to determine the outcome of a standardised spine exercise program on nursing students experiencing neck and low back pain, using a prospective randomised control design.

Effects of Body Mechanics Training on Shoulder-Back Pain and Breastfeeding Ergonomics in Breastfeeding Mothers

The research will be conducted as a randomized controlled trial and mothers in the intervention group will receive training on posture correction,breastfeeding positions, and shoulder and back muscle strengthening movements. If you agree to participate in this study, you will first be asked to fill out a form regarding your demographic information and health history.Then, the following scales will be applied to evaluate breastfeeding ergonomics, shoulder-back pain, and musculoskeletal system functions:Demographic and Health Data Form, Breastfeeding Ergonomics Scale, Visual Analog Scale (VAS) for Pain Assessment,Low Back Pain Function Scale, and Neck Disability Indicator Questionnaire. Mothers in the intervention group will receive training on body mechanics including posture awareness,breastfeeding positions, and shoulder and back muscle strengthening movements.The training will be conducted in the hospital and at 6 weeks and 3 months after discharge

Cannabidiol for Reduction of Brain Neuroinflammation

This study will investigate whether cannabidiol (CBD), the primary centrally and peripherally active non-intoxicating compound in the cannabis plant, exerts anti-neuroinflammatory effects in patients with chronic low back pain (cLBP) with or without mild-to-moderate depression.

Musical Mindfulness for Pain in the ED Waiting Room

Studies have shown that 60-70% of patients in the Emergency Department (ED) experience pain. With pain being such a broad issue in the ED, the ED is expected to deliver safe and effective treatment of pain. However, with the current ongoing opioid epidemic, it is important to consider other methods, both pharmacologic and nonpharmacologic, of pain reduction. Jazz music specifically has been demonstrated to have therapeutic effects on pain that can be used to lower the quantity of opioids administered to patients. Non-pharmacological interventions in the emergency department for pain typically consist of splinting an injury, applying heat or cold, or various distractions following initial and sequential pain assessment. Pharmacological interventions for pain in the Emergency Department involve the administration of acetaminophen, muscle relaxers, topical anesthetics, opioids, to name a few. In the emergency department (ED), providers are increasingly hesitant to prescribe opioids over the past decade due to the current opioid epidemic, in which there is an increasing proportion of people that develop an addiction to opioids, including those that are prescribed to them for pain management.. While emergency medicine providers' decrease in opioid prescriptions pertains to their implementation of opioid-prescribing policies, little evidence has been found demonstrating a direct link in these policies to decreases in substance misuse. Consequently, providers find themselves needing to become ingenious in their approach to pain in patients through the integration of pharmacologic and non-pharmacologic mediums of analgesia. A recent randomized controlled trial (RCT) from Brigham and Women's Hospital in Boston sought to identify the qualitative responses from patients in the ED following the arbitrary distribution of either supervised or unsupervised music therapy over a time period of 4 hours. The initial results found that, generally speaking, music therapy may lower reported pain and anxiety scores. Furthermore, stronger results were identified in case subjects with higher initial reports of pain via a pain catastrophizing scale, implying that a higher baseline of pain results in more relief from music therapy. One shortcoming in the article is the lack of analysis with reported results and the biopsychosocial model of pain. Heavy emphasis is placed on the psychological and social components of pain in the Brigham and Women's article through the implementation of the Pain Catastrophizing Scale and Brief Pain Inventory scoring done during the RCT, but no focus on linked biological changes in the subjects through the music therapy intervention. The purpose of this study is to (i.) assess the effect of a video training about musical pain management followed by a 15-minute music listening intervention on self-reported pain scores in ED patients with neck and back pain. The investigators also aim to (ii.) evaluate patient satisfaction and emotional response following the intervention. Opioid medications are commonly used to reduce substantial pain, and music therapy has been found to reduce associated pain and anxiety in patients, then the use of music therapy could be an aid in medicine to reduce opioid intake. The investigators hypothesize that the usage of a training on musical pain management combined with a specified jazz musical intervention will produce a significantly lower measured pain score in comparison to a video on mindful pain management followed by the patient's choice of activities.

Safety and Efficacy of Oral Cannabis in Chronic Spine Pain

The overall objectives of this study are to investigate the efficacy of extended cannabis treatment to reduce patient exposure to prescription opioids through its use 1) as a non-opioid analgesic treatment, and 2) as a therapy for reducing high-dose opioid use in patients with chronic spine pain.