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Low Back Pain, Recurrent clinical trials

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NCT ID: NCT04542798 Not yet recruiting - Neuropathic Pain Clinical Trials

CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting

Start date: October 2020
Phase: N/A
Study type: Interventional

The investigators will select two study groups from a population of patients with severe chronic low back pain (CLBP) of facet joint (FJ) origin already treated with conventional radiofrequency ablation (CRFA) of the medial branch of the dorsal ramus (MBDR) and that failed to obtain a 50% pain reduction measured through the numerical rate scale (NRS) for at least 3 months. Severe CLBP is considered a value of at least 7 by NRS pain assessment. The first group will be characterized by a nociceptive/mechanic type of back pain. The second group of study will be characterized by a neuropathic type of back pain. This difference will be established by a DN4 score of at least 4 points (Doleur Neurophatique 4). The patients in the group with nociceptive/mechanic back pain will be randomly assigned to conventional radiofrequency ablation or to water cooled radiofrequency (WCRF) of the MBDR. The patients in the group with neuropathic back pain will be randomly assigned CRFA of MBDR or to pulsed radiofrequency (PRF) of the dorsal root ganglia (DRG). The study will be carried on for an estimated time of 3 years. Primary outcomes will be: - at least 50% back pain reduction for at least 3 months evaluated through NRS, with a subcategorization of results that will consider a mean difference in effect (respect to the initial evaluation, with an initial NRS score of at least 7) of 1 point on NRS pain scale as small/modest, 2 points as moderate, more than 2 as large/substantial between the case/control study groups. - improvement of low back pain disability: 10 points increase on the Oswestry Low Back Pain Disability Questionnaire (ODI) have been proposed as minimal clinically important differences, between 10 and 20 as moderate, more than 20 as large/substantial clinical improvement at month 3 and 6. Secondary outcome will be evaluated by the 12-item short form survey SF12, accordingly with the clinical pre-interventional findings, analgesic intake at month 1-3-6 (if increased, unchanged, decreased, in dosages or number of pain killers' assumption). Groups sizes: will be calculated based on the disease's incidence and the outcome targets.

NCT ID: NCT04494841 Completed - Low Back Pain Clinical Trials

Usability of a Multimodal External Neuromodulatory Device to Relieve Acute Low Back Pain

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

Ten patients with acute or chronic low back pain will be invited to try a multimodal device for 20 minutes. Pain will be recorded prior to and after use, and feedback on the device will be elicited.

NCT ID: NCT04436003 Completed - Clinical trials for Degenerative Disc Disease

GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis

GDS
Start date: November 14, 2018
Phase: N/A
Study type: Interventional

Our purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain treatment for inoperable spine patients with degenerative changes in the lumbar spine, compared to "standard treatment" (any other chosen treatment). The pilot study will be conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot study will form the basis for a later full-scale randomized study and the following research questions will be addressed: 1. To what extent were the criteria for inclusion in the study suitable? 2. How did the recruitment procedure work? 3. How did the participants experience GDS treatment? 4. To what extent were the selected outcome measures suitable at the different evaluation moments, and which outcome measure tested in this pilot study would be most suitable as primary outcome measure in a full-scale study? (user experience will be included in the evaluation) 5. How was the change in the primary outcome measure (Oswestry Disability Index)? 6. What will be the estimated time for inclusion of the required number of participants in a full-scale study? (required sample size will be based on strength calculation /saving of the outcome target chosen as primary outcome measure for full scale study) The study is a pilot study with a randomized controlled design, with follow-up after 3-4 months. Thirty patients are recruited and receive baseline examination and respond to the questionnaires before randomization. The patients receive a questionnaire by mail 3-4 months after inclusion (after the treatment is completed for intervention group ). The pilot study will be one-way blinded.

NCT ID: NCT04415021 Completed - Clinical trials for Low Back Pain, Recurrent

Effects of Diaphragmatic and Iliopsoas Myofascial Release in Patients With Chronic Low Back Pain

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

The aim of this study is to effectively investigate the relaxation of the diaphragm and iliopsoas muscle with myofascial technique in patients with chronic low back pain.

NCT ID: NCT04074798 Recruiting - Clinical trials for Low Back Pain, Recurrent

Hyperventilation in Patients With Chronic Low Back Pain

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

Low back pain (LBP) is the leading cause of disability worldwide. Impaired postural control is a key factor in the development and maintenance of LBP. Moreover, the prevalence of LBP is associated with impairments in diaphragm function, symptoms of dyspnea, and dysfunctional breathing. However, the association between LBP (and more specifically postural control) and hyperventilation remains unknown. The main objective of this project is to investigate whether the presence of recurrent non-specific LBP is related to the presence of hyperventilation, when classified either objectively by decreased carbon dioxide values (demonstrating hypocapnia) or by symptoms while showing normal carbon dioxide values. Moreover, the investigators will explore whether psychosocial factors play a role in this relation. Subsequently, the investigators will examine whether hyperventilation in LBP patients is related to impaired postural control, and more specifically to a decreased postural contribution of the diaphragm.

NCT ID: NCT03994861 Completed - Neck Pain Clinical Trials

Dutch Version Fear-Avoidance Component Scale (FACS)

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Chronic musculoskeletal disorders such as low back and neck pain are responsible for an enormous global burden. Fear-avoidance (FA) can be a predictor for the transition from subacute to chronic low back pain. In patients with neck pain, those who were less fearful about harming their neck, had higher pain tolerance, which might have a positive impact on their level of disability. A new scale, the Fear-Avoidance Component Scale (FACS) was developed by Neblett, Mayer, Hartzell, Williams and Gatchel (2015) to assess FA. It consists of an all-encompassing set of constructs that more effectively deals with all critical issues of the FA concept than current scales do. Current scales have been criticized because of following findings: limited construct validity, little evidence on treatment responsiveness, a lack of evidence-based cut-off scores and items being too narrow or too general. The new scale comprehensively assesses all cognitive, emotional and behavioral components related to the updated version of the FA model by combining items of well-known scales in context of the FA model with items on one's perception of victimization and blame related to an injury. A Dutch version of the FACS is currently lacking. Subsequently, the aim of this study is to investigate different psychometric properties of the generated Dutch version in patients with musculoskeletal disorders.

NCT ID: NCT03984864 Recruiting - Clinical trials for Low Back Pain, Recurrent

Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Background: Low back pain, mainly nonspecific (NSLBP) is a major cause of pain and disability worldwide. Exercise therapy (ET) is considered as the first line treatment, and it is one of the treatment modalities most commonly used by physiotherapists. Yet, ET is reliant on the adherence of patients to its various components. Research has demonstrated a positive relationship between adherence to rehabilitation programs and recovery from a variety of musculoskeletal conditions. Therefore, factors that strengthen adherence to ET may increase its efficacy for NSLBP. Converging evidence from recent studies suggest that control and choice may increase adherence to various treatments. Therefore, the purpose of this study is to evaluate the effect of patient choice and preference on adherence and efficacy of exercise for recovery from NSLBP. Design: Matched case control study. Participants: Fifty subjects with chronic (>3 months) NSLBP. Twenty-five participants will be allocated to exercise by preference group, and 25 aged and gender controls will be allocated to exercise group. Inclusion criteria: 1. Non-specific low back pain (pain or discomfort in the lumbosacral area, with or without symptoms to the lower extremities), diagnosed by general physician or orthopedic surgeon. 2. Age 18-35 3. Chronic pain (greater than 3 months' duration). Exclusion Criteria: 1. Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents). 2. Previous (last three years) ET treatment for NSLBP. 3. Regularly performing exercise more than WHO's recommendation: - 150 minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity. - Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week. Procedure: After initial assessment, participants in the intervention group will be asked to choose 3-4 items from a list of 10 general exercises - intended for treatment of low back pain. Each matched participant in the control group will receive the same exercise (without the option to choose). Participants will be instructed to perform their exercises three times a week, for a period of four weeks (12 sessions total). Outcomes: Oswestry Disability Index (ODI) Henry-Eckert Performance Assessment Tool (HEPA) Both measurements will be taken on the first and last meeting. Additionally, each participant will fill a personal weekly exercise log (selecting between complete \ incomplete \ lack of execution) - sent by e-mail.

NCT ID: NCT03852667 Completed - Clinical trials for Low Back Pain, Recurrent

The Effect of Secondary Prevention in Patients With Recurrent Low Back Pain

Start date: September 29, 2019
Phase: N/A
Study type: Interventional

This study investigates the effect of a secondary intervention program for low back pain in patients with recurrent low back pain. One third of the subject will receive no therapy, one third wil receive 2 sessions of pain neuroscience education (PNE) and one third will receive two sessions of PNE and 5 sessions of exercise therapy over 6 weeks.

NCT ID: NCT03680287 Recruiting - Healthy Clinical Trials

Effects of Sleep Disruption on Drug Response

Start date: October 7, 2019
Phase: Phase 2
Study type: Interventional

The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects. The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing. The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(*) and healthy controls (N = 60). (*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.

NCT ID: NCT03554746 Completed - Clinical trials for Low Back Pain, Recurrent

Additional Gluteal Control Training for Low Back Pain With Functional Leg Length Inequality

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

Low back pain (LBP) is a prevalent musculoskeletal disorder. A variety of exercise interventions which were designed as randomized control trails (RCTs) have been studied and shown effectiveness in improving pain and disability. These exercises typically focus on the abdominal and back musculature strength. However, many LBP patients did not show any improvement in their symptom after they carry out those exercise programs.