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Low Back Pain clinical trials

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NCT ID: NCT03109548 Completed - Low Back Pain Clinical Trials

Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients

Start date: April 3, 2017
Phase:
Study type: Observational

The purpose of the project is to associate pre-treatment pain sensitivity level, levels of pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back Screening Tool in patients with acute low back pain and patients' progression after 12 weeks of treatment by general practitioners.

NCT ID: NCT03108339 Completed - Low-back Pain Clinical Trials

Markers of Outcome - a Cohort Study of LBP in Primary Health Care

MOS
Start date: December 1, 2018
Phase:
Study type: Observational

Low-back pain (LBP) is a complex and heterogeneous disorder commonly seen in primary health care. Despite a variety of treatment options available, it seems that few of these prevent recurrent LBP and chronicity. In addition, when comparing different treatment options, effect sizes are not impressive, indicating that we either lack effective treatment for LBP, diagnose poorly or that we measure the outcome of treatment incorrectly. Sub groups within the heterogeneous group suffering from LBP need to be identified and also markers influencing treatment efficacy. The project aims to conduct a cohort study with the objective to identify prognostic markers and sub groups for a successful or poor outcome of low-back pain and disability in short and long term. We aim to follow the trajectory of pain, to study interactions of markers and associations with days of pain and activity level. We will include people seeking physiotherapy care for a primary complaint of LBP to collect data on a core set of outcome measurements concerning pain, functional limitations, health and quality of life, self- efficacy and fear avoidance. The data will be collected at baseline, at 8 weeks and 6 and 12 months following an intervention of guideline recommended physiotherapeutic care comprising information to "stay active" and exercises enhancing core stability supervised by experienced physiotherapist. We aim to collect data on movement control of the lower back and general excessive mobility of the joints at base line. We will collect longitudinal data on days with troublesome pain and activity level through text-messages sent every 2 weeks. We will analyze the data with mixed model regression analyses and cluster analyses to be able to identify predictive factors and interactions to sub group the participants.

NCT ID: NCT03106740 Completed - Low Back Pain Clinical Trials

Evaluating the Role of Neuroinflammation in Low Back Pain

IGNITE
Start date: October 10, 2017
Phase: Phase 2
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. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.

NCT ID: NCT03101020 Completed - Clinical trials for Chronic Low Back Pain

Visceral Manipulation in Patients With Chronic Low Back Pain

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Non-specific chronic low back pain is a common multifactorial condition common to the world population. It is defined as a pain and discomfort located below the ribs and above the gluteal folds that may or may not have referred pain in the leg for more than 12 weeks. Visceral manipulation is a manual therapy technique that aims to normalize mechanical, vascular and neurological dysfunctions of the viscera with the objective of improving its functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low back pain in the presence of compromised movements between the internal organs and its connective tissues. There are two ways in which a change in visceral mobility could interfere with low back pain, referred visceral pain and central hypersensitivity. The first occurs due to neural convergence, since there is no spinocortical tract that only sends visceral or somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The second is that the prolonged and continuous activation of nociceptors, due to the alteration in the mobility of the gastrointestinal and urinary system, can generate central hypersensitivity. Therefore, the investigators hypothesized that through the visceral manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing the peripheral input, thus, lessening pain in the low back.

NCT ID: NCT03100266 Completed - Low Back Pain Clinical Trials

Probiotics for Modic Changes in Low Back Pain Patients

Start date: January 14, 2016
Phase: N/A
Study type: Interventional

Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised controlled study Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels. They are associated with disc degeneration, disc herniation and age, and are only seen on magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic changes have been described, type 1, 2 and 3, the latter being rare [5]. It has been shown that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse LBP outcome including a lower rate of return to work [7]. In addition, more inflammatory cells have been identified in this type of structural abnormality [25]. Modic changes may affect up to 20% of the general population and more than the double proportion in clinical populations, type 1 and 2 being about equally represented [6]. The investigators have estimated that at least 5,000 of the patients, who are referred to secondary health care in Denmark for LBP per year, will suffer from type 1 Modic changes. Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial with one year follow-up has been performed [16]. This trial documented significant effect of long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in patients with type 1 Modic changes. However, infection in Modic changes has not been documented convincingly in this or in other studies, and almost all of the treatment effect occurred after the antibiotic treatment was stopped. As yet, the study has not been replicated. The investigators hypothesize that the treatment effect may have been caused by an effect on the gut microbiom possibly explaining the delay of the effect. Probiotics have been shown to influence interleukins in patients with inflammatory conditions and in healthy volunteers [32, 36, 37]. The investigators are therefore performing a randomised trial to study the clinical effect of probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is designed as a randomised, clinical, double blind, placebo-controlled trial taking place at the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller treatment effect than the effect found in the study above and resulted in the requirement of including 94 patients. One-year follow-up is planned. The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain has been used in several clinical studies. The dietary supplement has been shown to influence relevant interleukins significantly, and it has been proven to be stable in action and safe, also in pregnancy. A positive result of such a trial may have significant consequences. The perspective of using probiotics instead of antibiotics in this common disorder is very attractive. At the time being, many type 1 Modic patients in Denmark and other western countries are treated with antibiotics. This is of great concern because of side effects and possible drug resistance development of bacteria. The Technology Transfer Office of Aarhus University is involved.

NCT ID: NCT03099941 Completed - Clinical trials for Low Back Pain, Mechanical, Biofeedback, Pain, Chronic

The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain

Start date: May 11, 2015
Phase: N/A
Study type: Interventional

Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus muscles is the most important cause of the chronic nonspecific low back pain (CNLBP). Recently, applications sre developed that generates audio and vibrant stimuli in response to anteroposterior and mediolateral rotations and can be adapted according to subject-specific movement sensitivity. Objective. The objective of this study was to compare effects of a biofeedback application that is alternative to physiotherapist feedback in core stabilization training of patients with chronic nonspecific low back pain. Design. This study was a parallel group randomized controlled trial with outcome assessment. Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back pain. Interventions. Patients were randomly assigned to receive either physiotherapist feedback or Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12 sessions, 30 minutes of three weekly graded functional core education trial. Measurements. Primary outcome measures were muscle strength (transversus abdominus and multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry Disability Index); secondary outcomes were flexibility (modified Schober test), range of motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs (Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and quality of life(36 Item Short-Form Health Survey questionnaire [SF-36]). Limitations. Outcome measures for muscle strength did not include objective assesment. Keywords. Chronic low back, core stabilization training, biofeedback, pain, function

NCT ID: NCT03097718 Completed - Low Back Pain Clinical Trials

Central Proprioceptive Processing and Postural Control in LBP

Start date: January 2016
Phase:
Study type: Observational

This project aims to elucidate neural correlates of proprioceptive deficits in patients with recurrent non-specific low back pain, by studying whether brain activation patterns during the processing of proprioceptive signals from the ankle muscles and lower back muscles are altered compared to healthy control subjects.

NCT ID: NCT03097497 Completed - Clinical trials for Chronic Non-specific Low-Back Pain

Physiotherapy Re-education of Pre-activation of the Transverse Abdominis in Patients With Chronic Low Back Pain

Start date: April 30, 2017
Phase: N/A
Study type: Interventional

Hypothesis: The hypothesis of the study is that the physiotherapeutic re-education of the pre-activation of the transverse abdominal muscle decreases pain intensity in patients with chronic non-specific low-back pain by at least 30% and is more effective than conventional treatment. Aims: the principal aim is to determine the effectiveness of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on pain intensity in adult patients diagnosed with chronic non-specific low-back pain compared to conventional treatment in a primary care setting. The secondary aims of the study are to assess the effects of a physiotherapeutic re-education program based on the pre-activation of the transverse abdominal muscle on: (1) disability and limitations for the development of the activities of daily living associated with LBP, (2) transverse abdominal muscle muscle contraction, (3) to assess whether the resistance training parameters applied to older adults are valid for young adults and (4) to determine whether the training protocols used for the cervical spine could be extrapolated to the lumbar spine.

NCT ID: NCT03097263 Completed - Clinical trials for Non-specific Low Back Pain

Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient

MARLO
Start date: January 2014
Phase: N/A
Study type: Observational

Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).

NCT ID: NCT03089931 Completed - Low Back Pain Clinical Trials

Change of Lumbar Symptom After Surgical Treatment for Patients With Cervical Stenosis

LBP
Start date: November 11, 2012
Phase:
Study type: Observational [Patient Registry]

Low back pain may be reduced after cervical spinal surgery