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Back Pain, Low clinical trials

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NCT ID: NCT03891264 Terminated - Back Pain, Low Clinical Trials

Investigation of Cannabidiol for Reduction of NeuroInflammation in Chronic Back Pain

CBD
Start date: November 13, 2019
Phase: Phase 4
Study type: Interventional

In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain, and whether CBD effects levels of neuroinflammation. The efficacy of CBD use for low back pain treatment will also be evaluated by observing whether CBD administration will reduce neuroinflammation and low back pain symptoms.

NCT ID: NCT03570463 Recruiting - Back Pain, Low Clinical Trials

GLA:D® Back: Patient Education and Exercises for Self-management of Back Pain

Start date: April 11, 2018
Phase:
Study type: Observational [Patient Registry]

The GLA:D Back project evaluates the implementation of standardised patient education and exercise therapy for people with persistent or recurrent low back pain (LBP) in a hybrid implementation-effectiveness design. This involves evaluating the process of implementation as well as clinician level outcomes and patient level outcomes. GLA:D (Good Life with OsteoArthritis in Denmark) is a non-profit initiative and registered trademark from the University of Southern Denmark. It educates clinicians in delivering evidence-based care for musculoskeletal health conditions and registers outcomes in a clinical registry. GLA:D Back uses only the acronym. The main activity of the implementation strategy is a two-days course for physiotherapists and chiropractors in delivering patient education and exercise therapy that is aimed at supporting patient self-management of LBP. This comes with ready-to-use patient education materials and exercise programs. The course is targeted at chiropractors and physiotherapists, but any health care provider authorised to treat patients with back pain in Denmark can participate, i.e. medical doctors, physiotherapists and chiropractors. The clinical intervention is a group-based program consisting of two sessions of patient education and 8 weeks of supervised exercises. The program uses a cognitive-behavioural approach and the aim of the exercise component is to restore the patient's ability and confidence to move freely. Clinicians decide which patients are offered the program. The implementation process is evaluated in a dynamic process monitoring the penetration, adoption and fidelity of the clinical intervention. The education of clinicians is evaluated via clinician-level outcomes concerning attitudes towards back pain and confidence in managing people with LBP. The clinical intervention and potential effect mechanisms are evaluated at the patient-level in an observational design. Patients who are participating in the GLA:D Back program are followed using measures of knowledge, skills, beliefs, performance, self-efficacy and success in self-management. Effects at a national level will be investigated via data from national registries of health care utilisation and sick-leave. Patient- and clinician reported data are collected in a registry.

NCT ID: NCT03449160 Withdrawn - Back Pain, Low Clinical Trials

Postural Training Device (UPRIGHT) for Back Pain

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

Participants with low back pain who are referred for physical therapy will be randomized to routine physical therapy or routine physical therapy plus receiving a postural training device

NCT ID: NCT03377088 Suspended - Back Pain Clinical Trials

Aromatherapy Randomization of Pain Management in Adults

AROMA
Start date: December 11, 2017
Phase: N/A
Study type: Interventional

Pain control for acute isolated back pain and sciatica is a nebulous and often illusive task in the emergency department, and a challenge face everyday by emergency medicine physicians. Standard pain control practices are poorly defined in practice and in the literature. NSAIDs alone have been shown to be less-than-adequate controllers of acute back pain warranting emergency department visits and have little bearing on long-term pain control or recovery. Opioids are additionally poor long-term pain controllers and are gaining public controversy for their overuse. Modalities such as acupuncture, massage, thermotherapy, and spinal manipulation have been described in the literature with minimal evidence. Aromatherapy for pain control has been recently demonstrated as effective in the management of burn-dressing changes as well as post-operative pain management in children. It is an inexpensive and easily employed modality not yet explored in the emergency department for acute pain such as isolated back pain and sciatica. The authors propose to study Rosa damascena oil aromatherapy for the control of isolated acute back pain in the emergency department compared to almond oil placebo. The authors hypothesize that Rosa damascena will provide additional pain relief, as a known analgesic, when compared to almond oil aromatherapy. The authors will identify patients presenting to the Stony Brook University Hospital (SBUH) Emergency Department (ED) with acute isolated back pain and sciatica and test this hypothesis using a blind randomized approach. Patients included will be those above the age of 18 with isolated, non-traumatic back pain and sciatica lasting less than 2 weeks. Primary outcomes measured will include decrease in pain severity on a visual analog scale after 30 minutes of aromatherapy and again at 60 minutes post-therapy. Secondary outcomes measured will include patient satisfaction, need for clinician-determined rescue medications, and minimal clinical importance difference of pain control. Aromatherapy will be provided with both essential oil concentrated Rosa damascena and almond extract delivered via soaked-cotton ball 20-30 cm from the patient's face.

NCT ID: NCT03294148 Completed - Chronic Pain Clinical Trials

Mind-body Treatments for Chronic Back Pain

Start date: August 7, 2017
Phase: N/A
Study type: Interventional

Participants with chronic back pain will complete an online prescreen. They will then be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. Participants will then complete an in-person eligibility session, and eligible participants will be scheduled for the baseline assessment session. Following the baseline assessment session, participants will then be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist. The placebo treatment is a subcutaneous injection of saline into the back. Participants will know that the treatment is a placebo, i.e., it is an "open label" placebo. Psychotherapy (8 sessions) will be supervised by Alan Gordon and Howard Schubiner. Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2, 3, 6, and 12 after the final assessment session. These will provide longer term data about the trajectory and durability of patient improvement. Additionally, a group of healthy controls, with no history of back pain, will complete the baseline assessment. They will serve as a comparison group to probe whether the patterns of observed brain activity is specific to CBP patients.