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Chronic Low Back Pain clinical trials

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NCT ID: NCT05363579 Recruiting - Clinical trials for Chronic Low-back Pain

A Study on the Effectiveness of Tuina in Managing Chronic Low Back Pain

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

Low back pain (LBP) is a common clinical symptom prompting patients to seek medical care. 80% of adults experience LBP during their lifetime. The causes of CNLBP are still not fully elucidated and there is currently no gold standard treatment for CNLBP. The mainstay of conservative treatment for CNLBP includes pharmacological interventions, weight loss and physiotherapy. More recently, Tuina, a component of Traditional Chinese Medicine, has been used to treat CNLBP as well. Tuina is mainly applied to the meridians or acupoints by manipulation techniques such as pushing, grasping, pressing and rubbing of the soft tissues or muscles of the body. It is reported to improve circulation and the qi in the body. However, recent systematic reviews on the efficacy of Tuina in the management of CNLBP were not able to definitively conclude the effectiveness of Tuina due to the poor methodological quality of the studies. Therefore, this study is a single blind, randomized controlled trial (RCT), which aims to determine the efficacy and safety of Tuina in the management of CNLBP. Similar studies are also conducted in China (First Affiliated Hospital of Jinan University) and USA (Mayo Clinic). Patients from SGH Orthopaedic clinics with CNLBP, will be recruited for this RCT, and will be randomly divided into 3 intervention groups: Physiotherapy intervention group as the control group, Tuina intervention group, and combined intervention (Tuina + Physiotherapy) group. The intervention will last for 2 months, and follow up assessments will be conducted at the 5th month. Outcome measures include Visual Analog Scale (VAS), Spinal range of motion, Oswestry Disability Index (ODI), TCM Syndrome scale and quality of life 36 item short form survey, (SF-36).

NCT ID: NCT05351541 Recruiting - Clinical trials for Chronic Low-back Pain

Psilocybin Therapy for Chronic Low Back Pain

POP
Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Patients may be recruited at Stanford and University of California San Francisco (UCSF), study procedures will occur at UCSF. Each participant will receive a dose of psilocybin with possibly one or more other drugs. Participants will undergo two preparation sessions, a dosing session, three integration sessions to discuss their psilocybin experience, and several follow up sessions.

NCT ID: NCT05345015 Recruiting - Clinical trials for Chronic Low-back Pain

High Frequency RF Current Effects on Muscle Pain and Function

Start date: April 30, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "TECAR") on pain and functional movement in individuals with a musculoskeletal injury or pain. The participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (Acute effects) as well as 3 and 6 months after the intervention (chronic effects).

NCT ID: NCT05331274 Recruiting - Clinical trials for Chronic Low Back Pain

The Effect of Structured Pain Education on Pain and Performance Parameters in Patients With Chronic Low Back Pain

Start date: April 15, 2022
Phase: N/A
Study type: Interventional

The Effect of Structured Pain Education on Pain and Performance Parameters in Patients with Chronic Low Back Pain The aim of this study is to compare the effects of only Low Load Motor Control Exercises and Pain Education in addition to these exercises on pain, performance, disability and psychological factors, and to present a generalizable pain education in patients with chronic low back pain. We think that DYMK exercises applied together with a general Pain Education given to the patients will provide more improvement on these factors. The patients will be divided into 2 groups, as a pain training group and an exercise group, with 20 people in each group, in a randomized controlled manner. Only DYMK exercise training will be applied to the exercise group. In the pain training group, pain training will be applied in addition to the DYMK exercise training. As an evaluation parameter to the participants; Numerical Rating Scale, Short-Form McGill Pain Questionnaire, Pain Catastrophizing Scale, Tampa Kinesiophobia Scale, Roland-Morris Disability Questionnaire, Pain Self-Efficacy Questionnaire, Passive Lumbar Extension Test, Finger-Place Test and Physical Performance Test Battery will be applied. Patients will be evaluated before the start of the study (T0) and at the end of the study (T1). Low Load Motor Control Exercises will be applied to people in both groups for 4 weeks, 3 days a week, during 20-30 minute sessions. In addition to the DYMK exercise training, a session of 30 to 50 minutes of Pain Training in groups of 4 to 5 people will be given to the patients included in the Pain Training group at the beginning of the exercise training and the exercise training will begin.

NCT ID: NCT05294081 Recruiting - Clinical trials for Chronic Low Back Pain

EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain

EFFECT-BACK
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability. Exploratory research will also be conducted to identify predictors of which patient groups benefit more from which method. This should optimise treatment options and create effective treatment offers for subgroups of pain patients. Exposure therapy is an effective and economical treatment modality and was shown in a previous pilot study to be superior to CBT in reducing perceived movement limitation. CBT, on the other hand, appeared to be more effective in establishing coping strategies. With the help of the current study it should be possible to compare the effectiveness of both treatment methods and, in perspective, to identify those patient groups that benefit from exposure therapy and thus create a tailor-made treatment programme for subgroups of pain patients. A total of 380 patients (age: ≥ 18) with chronic back pain and a sufficient degree of impairment will be included and analysed in the study.

NCT ID: NCT05265000 Recruiting - Clinical trials for Chronic Low-back Pain

Transcutaneous Spinal Cord Stimulation for Chronic Low Back Pain

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

As a leading cause of disability worldwide, chronic low back pain (cLBP) represents a significant medical and socioeconomic problem with estimated health care spending of $87 billion/annually. The efficacy of dorsal column electrical stimulation to inhibit pain was first described over 50 years ago. Since then, several large clinical trials have investigated the therapeutic potential of electrical spinal cord stimulation (SCS) and found that over 70% of patients with intractable pain had over 50% pain relief after 1 year of treatment. Thus, SCS is a promising therapeutic intervention that has superior patient outcomes when compared to traditional modalities for the treatment of cLBP. To date, SCS for treatment of cLBP has been delivered via epidural electrodes, requiring neurosurgical implantation. Although, the implantable stimulators have a low rate of adverse events, secondary complications associated with surgical intervention still occur.Transcutaneous spinal cord stimulation (tSCS) is a rapidly developing non invasive neuromodulation technique in the field of spinal cord injury. Its application potentiates lumbosacral spinal cord excitability enabling motor functions, (e.g. independent standing, postural control) in patients with chronic complete motor paralysis. Given that epidural and transcutaneous SCS activate similar neuronal networks, tSCS for cLBP treatment may be advantageous due to its non-invasive nature which may also allow for a mass market production and rapid patient availability if tSCS is proven efficacious. In this pilot study we will establish the feasibility of tSCS to acutely improve patient reported outcomes (pain scores) and several objective measures, including sit-to-stand biomechanics, neurophysiological and neuroimaging outcomes.

NCT ID: NCT05234008 Recruiting - Clinical trials for Chronic Low-back Pain

Technology Supported High Intensity Training at Home for Persons With Chronic Low Back Pain

HIT-HOME
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

1. Background 1.1 Introduction Chronic low back pain (CLBP) is the most disabling musculoskeletal disorder worldwide4. Exercise therapy can improve CLBP, but effect sizes remain modest. Recently, our research group has shown that high intensity training (HIT) is a feasible and effective therapy modality to significantly improve physical fitness and reduce functional disability in comparison to moderate intensity training in persons with moderately disabling CLBP9. However, persons with CLBP often do not continue exercising after discharge, which can lead to a decline of (long term) treatment effects. A technology supported home program, that guides the substantial effort that is necessary for further improvement, may enhance (the retention of) training effects. 1.2 Objective, research questions, and hypotheses Primary objective: To evaluate the feasibility of a technology supported HIT program performed at home in persons with CLBP. Secondary objective: To assess the clinical effectiveness of a technology supported HIT program performed at home in persons with CLBP. Research questions and hypotheses: Research question (RQ)1 - To which extent is it feasible to perform HIT at home in persons with CLBP? Hypothesis (HP)1 - A high intensity training program performed at home by persons with CLBP is feasible, conceptualized by retained or improved participant motivation, high therapy adherence, and absence of adverse events. RQ2 - To which extent is it feasible to use Physitrack as a supportive technology application during HIT at home in persons with CLBP? HP2 - It is feasible to use Physitrack to support persons with CLBP that perform a HIT program at home (i.e. provide information concerning the exercise program and provide feedback), conceptualized by an evaluation of the Physitrack application on the usability score of 'above average'. RQ3 - To which extent is a technology supported HIT program an effective therapy modality to treat persons with CLBP? HP3: A technology supported HIT program is an effective therapy modality to treat persons with CLBP, conceptualized by a significant increase in physical fitness, and decrease in pain intensity and functional disability.

NCT ID: NCT05232487 Recruiting - Clinical trials for Chronic Low-back Pain

Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain

Start date: January 2023
Phase: N/A
Study type: Interventional

Low back pain (LBP) is very common, widespread, and represents a multidimensional syndrome. It affects physical activity and function, health-related quality of life, and employment status. The lifetime prevalence of acute low back pain is approximately 80%. The prevalence of chronic low back pain (CLBP) in the general population is reported to be 8% to 21%. Several clinical trials have provided evidence to support the efficacy of acupuncture in the treatment of LBP, however, the optimal acupuncture treatment for CLBP has not been extensively studied.

NCT ID: NCT05209854 Recruiting - Clinical trials for Chronic Low Back Pain

Evaluation of Therapeutic Management in Chronic Low Back Pain Patients

PREDIPAIN
Start date: March 2, 2023
Phase:
Study type: Observational

Seventy-eight percent of the population declares being concerned by pain, directly or indirectly. Chronic pain, defined as pain that has lasted for more than three months, affects more than one third of the French population. The national survey of the French Society for the Study and Treatment of Pain (SFETD), conducted in 2009, reveals that the most widespread chronic pain is low back pain (20%). Pain not only affects the body, but also destroys the person who endures it. A comparative study by Attal et al. carried out on a sample of 1,591 chronic pain sufferers and 1,237 non pain sufferers shows a major impact of pain on the individual's quality of life (SF12), sleep (MOS sleep) and anxiety and depression (HADS). The 2009 report of the French National Authority for Health (HAS) shows that chronic pain generates a significant societal cost. Low back pain is the leading cause of activity limitation in people aged 45 to 65, and the third leading cause of chronic disability. It is the leading cause of disability in people under 45 years of age, and the leading cause of work stoppage and occupational disease. The reference tool for assessing pain is currently the Visual Analogue Scale (VAS). However, several factors considerably limit the relevance of an exclusive use of this tool: - For the patient: the intensity of pain is objectively influenced by many parameters such as the time of day, stress, position, duration of evolution, mechanical or "neuropathic" character, paroxysms, etc. These are all elements that objectively disrupt the evaluation performed by the VAS. When the subjective and emotional dimension is included in these elements, the cloudiness of "true" perception of such a sensation increases even more. - Difficulties of evaluation for the carer: carers are therefore confronted with a lack of relevance of objective pain evaluation tools, and researchers have to deal with data that are often not very reproducible. A fortiori, the second problem arising from this concerns the difficulty of comparing the effectiveness of different therapeutic strategies. The VAS cannot, for example, take into account the pain dominance in the case of multi-site pain, nor the surface area of the pain zone or even less its typology or topology. This information is however essential to determine the choice of the most appropriate therapeutic strategy. - The difficulties of evaluation for the health care system: in fact, beyond the therapeutic wandering imposed on certain patients on a "micro" scale, it must be considered that this randomness of evaluation has an impact on the entire health care system. When a decision has to be made to reimburse a particular expensive drug or implantable medical device for pain relief, this reflection has to be extended to the "macro" level. This review thus reveals a threefold need for innovation in pain assessment: for the patient, for the caregiver and for the healthcare system.

NCT ID: NCT05202704 Recruiting - Clinical trials for Chronic Low Back Pain

Investigating the Hypoalgesic Effects of Manipulative Therapy Using Pain Conditioning and Expectations in Low Back Pain

Start date: February 20, 2022
Phase: N/A
Study type: Interventional

The objective of this study will be to identify whether a conditioning procedure by the surreptitious downgrade of a noxious stimulus intensity associated with induced positive expectations about treatment will result in greater hypoalgesic effects when compared to positive verbal suggestions (positive expectation induction) alone regarding the effects of spinal manipulative therapy intervention in patients with CLBP. This study will enroll 264 individuals with CLBP aged between 18 and 60 years. Spinal Manipulative Therapy in the lumbar spine will be administered to all participants during 5 sessions. First assessment session - participants will be submitted to a quantitative sensory testing (QST) to determine the heat pain threshold (calibration test) to run the conditioning procedure. Afterward, participants will be allocated by a blinded researcher into the following subgroups: hidden conditioning + positive expectation (G1); positive expectation alone (G2) and a group submitted to neutral expectations (G3) about the treatment. First treatment session - Firstly, participants will receive instructions with the aim to induce positive (or neutral) expectations by means of a workshop. Secondly, all the participants will be submitted again to the pre-conditioning test, using the more intense pain stimulus obtained in the calibration test, then patients will be assessed regarding pain intensity and finally submitted to the manipulative therapy. At the end of the first treatment session, the conditioning test will be repeated, but the heat pain threshold of the hidden conditioning group (G1) will be surreptitiously downgraded (from intense pain stimulus to moderate pain stimulus) as a means of conditioning patients to believe that manipulative therapy promoted pain relief. Pain intensity will be assessed again to confirm a decrease in pain intensity. Outcomes will be assessed three times: immediately after the five therapy sessions, one month later, and three months later. The primary outcomes assessed will be pain intensity and global perceived effect of improvement. The secondary outcome will be low back pain disability.