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Back Pain clinical trials

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NCT ID: NCT04507074 Active, not recruiting - Obesity Clinical Trials

The Effect of Traction Forces in People With Obesity Suffering From Chronic Low Back Pain

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

The purpose of the research study is to assess the impact of traction forces on changes in systemic markers concentrations of spinal structure damage in people with obesity. The research group will include 40 subjects aged 35-60 with simple obesity (BMI ≥ 30 kg / m2) and chronic lumbar spine pain syndrome. The control group will consist of 20 subjects with normal body weight suffering from the same pain, at a similar age to the patients in the study group. Persons will be qualified for examination by a specialist in internal medicine and a physiotherapist. To assess the degree of structural damage within the intervertebral disc and adjacent anatomical structures, patients will undergo magnetic resonance imaging of the lumbosacral spine (MRI 1.5T, standard in 3 projections). Patients will undergo traction therapy under the supervision of a physiotherapist. The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight). Twice, before and after therapy, the following will be assessed: (1) body composition (by DXA method), (2) other anthropometric indicators, (3) functional parameters of the spine: mobility (electrogoniometer), muscle bioelectric signal amplitude (electromyograph), soft tissue biophysical parameters (myotonometer), (4) pain threshold and intensity in the lumbar region (using an algometer and validated questionnaires), (5) disability caused by pain in the spine (Oswestry questionnaire), (6) blood biochemical indicators selected on the basis of the latest research on biomarkers of spinal damage (for this purpose, 25ml venous blood will be taken from the subjects). Blood levels of interleukin-17, interleukin-4, interleukin-2 (IL-2), interleukin-10 (IL-10), differentiating growth factor 15 (GDF-15), leptin, adipsin, chemokine CCL5 (RANTES), stem cell growth factor β (SCGF-β), vascular endothelial growth factor (VEGF), neuropeptide Y, and chondroitin sulfate CS846 will be determined in the blood of the subjects. It is planned to assess the relationship of the studied biomarkers with the degree of disk degeneration, obesity, lean and fat body mass, pain intensity, and functional indicators of the spine. Patients will be asked to stop taking anti-inflammatory drugs during therapy and at least 24 hours prior to blood sampling.

NCT ID: NCT04494698 Active, not recruiting - Opioid Use Clinical Trials

Impact of DuoTherm on Opioid Use and Chronic Low Back Pain

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

Evaluate opioid use and pain change in chronic Low Back Pain with DuoTherm Compared to Active Control

NCT ID: NCT04494490 Active, not recruiting - Low Back Pain Clinical Trials

Resolving the Burden of Low Back Pain in Military Service Members and Veterans: A Pragmatic Clinical Trial

RESOLVE
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The RESOLVE trial will provide a pragmatic approach to evaluate whether Physical Therapy Clinical Practice Guideline adherence can reduce pain, disability and downstream healthcare utilization for low back pain within the Departments of Defense and Veterans Affairs healthcare systems.

NCT ID: NCT04491175 Active, not recruiting - Low Back Pain Clinical Trials

Impact of DuoTherm on Acute Opioid Use and Low Back Pain

Start date: June 23, 2022
Phase: N/A
Study type: Interventional

Evaluate opioid use and pain change in acute Low Back Pain with DuoTherm Compared to TENS Therapy Unit

NCT ID: NCT04411420 Active, not recruiting - Low Back Pain Clinical Trials

Improving Veteran Access to Integrated Management of Back Pain

AIM-BACK
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.

NCT ID: NCT04246281 Active, not recruiting - Low Back Pain Clinical Trials

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

Start date: June 17, 2020
Phase: N/A
Study type: Interventional

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)

NCT ID: NCT04238676 Active, not recruiting - Clinical trials for Chronic Low-back Pain

Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain

Start date: January 20, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.

NCT ID: NCT04236804 Active, not recruiting - Clinical trials for Chronic Low-back Pain

Implementing TMC-CP01 Treatment Based on the Virtual Autonomic Neuromodulation Induced Systemic Healing System in Reducing Pain and Opioid Requirement in Subjects Suffering From Chronic Low Back Pain

VANISH
Start date: June 17, 2020
Phase: N/A
Study type: Interventional

The program, called TMC-CP01, will use a combination of virtual reality, biofeedback, and psychological exercises to manage pain associated with Chronic Low Back Pain. Chronic pain affects an estimated 100 million Americans, around one-third of the U.S. population. One of the most prevalent conditions under chronic pain is Chronic Low Back Pain (CLBP). About 27% of chronic pain patients experience CLBP. It is the leading cause of disability in the world and 31 million Americans suffer from CLBP. The most common analgesic tool for pain patients, especially for LBP patients, is opioids. However, opioid users are subject to drug tolerance and physical dependence, which decreases efficacy and increases risk of complication. Long-term users often require doses up to ten times their original dose to achieve equivalent analgesia and, after months of exposure, patients' risk of addiction increases. This project aims to introduce a digital intervention to standard CLBP management with a virtual reality-enabled pain management system that will improve pain management and decrease daily dosages of opioids.

NCT ID: NCT04141098 Active, not recruiting - Clinical trials for Degenerative Disc Disease

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy

LOPAIN1
Start date: October 10, 2019
Phase: N/A
Study type: Interventional

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.

NCT ID: NCT04129450 Active, not recruiting - Chronic Pain Clinical Trials

Group-based Mindfulness for Chronic Pain in the Primary Care Setting

OPTIMUM
Start date: May 6, 2021
Phase: N/A
Study type: Interventional

The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.