Mobile App-delivered Sleep Therapy (SleepFix) for Individuals With Chronic Low Back Pain and Insomnia...
Chronic Low-back PainInsomniaThe goal of this clinical trial is to assess the efficacy of a digital behavioral therapy for insomnia (dBTi) in people with chronic low back pain and insomnia. The main question it aims to answer is whether a 3 week period of dBTi can improve pain-related interference 6 weeks from commencement. Researchers will compare the treatment (dBTi) to an active control (Sleep health education modules) to see if there is a significant difference in outcomes at baseline and end-of-study (6 weeks).
Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
Chronic Low-back PainLow back pain is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Unfortunately, substantial improvements in people with chronic low back pain are rare, causing most people to live with the pain. People with chronic low back pain may have an exaggerated pain response to nociceptive input into tissues that are may also cause symptoms distant from the site of the primary symptoms. Historically, these symptoms were thought to be related to pathoanatomic changes to the muscles, ligaments or joints. However, the severity of these structural changes weakly correlates with the clinical presentation and in most cases, is not directly related to diagnostic images findings. Patients with chronic musculoskeletal pain, in general, show signs of local/central sensitization. The central sensitization may appear to be directly correlated with the intensity and duration of pain. Therefore, it is essential to reduce pain intensity and minimize the duration of pain to prevent this from happening. Pain relief for chronic low back pain patients should be aimed at treatments that reduce central excitability and increase central inhibition. Research into chronic low back pain treatment has demonstrated strong evidence that different types of exercise decrease pain and improve quality of life. However, exercise itself may be painful, and the pain may prevent a person from exercising. Thus, treatments aimed at decreasing pain will improve a person's ability to exercise and participate in activities of daily living. One treatment aimed at reducing central excitability and increasing central inhibition is transcutaneous electrical nerve stimulation (TENS). TENS is a "non-pharmacological" treatment for pain that is inexpensive, safe, and easy to use. Prior studies show that TENS utilizes opioid receptors both spinally and supraspinally to inhibit nociceptive dorsal horn neurons, reduce excitatory neurotransmitter release and reduce hyperalgesia. Thus, TENS may be particularly useful in people with chronic low back pain for its ability to activate descending inhibitory pathways (reduced in chronic low back pain patients) and to inhibit central excitability (increased in chronic low back pain patients). Previous studies that have investigated the effects of TENS on pain in low back pain patients have failed to use proper intensities of current, and the assessment of pain was not performed during the peak of the analgesic response. Previous studies show that inadequate intensities do not reduce pain or increase pressure pain thresholds. Further, TENS typically does not affect resting pain, while changes in pressure pain thresholds and pain with movement are reduced. Thus, the current study proposes to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS applied to a large area of the trunk.
Education of Municipality-based Physiotherapists in Managing Disabling Low Back Pain - an Observational...
Low Back PainA consistent theme in the modern-day healthcare system is the difficulty of transferring research knowledge into clinical practice. Recently, it has been pointed out that this is a barrier for providing care that is evidence-based which may partly explain the growing burden of low back pain. Low back pain, as all other musculoskeletal pain conditions is multidimensional where biomedical and psychological factors need to be accounted for, as well as the patient's social context. From the healthcare provider perspective, this requires skills that often goes beyond the basic training where clinicians need to be able to assess and manage the multiple domains in a patient-centered manner. In Denmark, people living with disabling low back pain can be referred to a municipality-based rehabilitation program. This study seeks to investigate whether providing physiotherapists an evidence-based educational course on the management of low back pain will change patient-related outcomes. Likewise, we will investigate potential barriers and facilitators for implementing the skills the physiotherapists acquire in clinical practice. If the project shows a favorable effect, it will allow for upscaling the intervention within and across municipalities. Moreover, a positive outcome may provide indications of what type of continuing education resources should be made available to help clinicians better manage complicated low back pain problems.
Confidence in the Ability to Perform Movements in Patients With Low Back Pain
Low Back PainThe goals of this observational study are: To determine the validity and reliability of the OPTIMAL-confidence scale in people with chronic low back pain. To assess the influence of confidence and fear of movement on the evolution of low back pain. The main question it aims to answer is if people with chronic low back pain present different psychoemotional variables around fear of movement and decreased confidence in their ability to perform movement that may influence their low back pain. For this purpose, a two-phase study was designed. In the first phase, the OPTIMAL-confidence scale will be validated in patients with chronic low back pain, determining its internal consistency and validity. In the second phase, a prospective study will be carried out with patients with low back pain who attend physiotherapy centres to determine how confidence and fear of movement influence the characteristics of pain and its evolution. Data will be collected at the beginning of the physiotherapy treatment, at the end of the treatment and after three months. The data will be analysed using learning machine techniques.
Efficacy of a Short Multidisciplinary Education and Rehabilitation Program for Patients With Subacute...
Non Specific Low Back PainThe main purpose of this study is to assess the clinical efficiency of an intervention including a short multidisciplinary program of education and rehabilitation and a personalized follow-up, in patients with subacute and chronic low back pain and no severe disability. The secondary objectives are: to assess the capacity of the program to modify and reduce the risk factors for evolution of patients towards a severe disability, to estimate the cost-utility ratio of the intervention.
Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain
PainPain Syndrome7 moreOver the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic back pain disorders. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic back pain.
The Impact of Positive, Neutral and Negative Expectation Speech on Manipulative Therapy Effects...
Chronic Low-back PainThe objective of this study will be to identify the short-term impact of positive, neutral, or negative speech on pain intensity (primary outcome). The secondary outcomes assessed will be the global perceived effect of improvement, patient's expectations regarding spinal manipulative therapy (SMT) intervention, and perception of empathy in the therapeutic encounter in patients with chronic low back pain (CLBP). This study will enroll 60 participants with CLBP aged between 18 and 60 years. This is an exploratory randomized clinical trial. The three groups will receive a manual therapy session after watching the video proposed for their group. First participants will be assessed for pain intensity, low back pain disability, psychosocial aspects, and expectations related to treatment. Secondly, a researcher not involved in the recruitment of patients will randomly allocate the participants into three different groups (G1- group submitted to positive expectation, G2- group submitted to neutral expectation, and G3- group submitted to negative expectation). After the allocation, the participants will watch a short video (no more than 3 minutes) delivering positive, negative, or neutral messages regarding SMT. And finally, a physiotherapist will administer one session of SMT and participants will be re-assessed to investigate the immediate effect of the videos on the pain intensity, global perceived effect of improvement, and expectations. Ultimately, patients will be submitted to a semi-structured interview in which their perceptions about the videos will be investigated. Outcomes will be assessed just immediately after one SMT session.
Effect of Plantar Fascia Release on Patients With Chronic Non-specific Low Back Pain
Chronic Low-back PainThe purpose of the current study is to determine the effect of myofascial release of plantar fascia on pain, back function, lumbar flexibility and pain pressure threshold for patients with CNSLBP.
Protocol for an Analytical Study With Microbiological, Phenotypic, Genotypic and Multiomics Techniques...
Back PainLow1 moreThe study aims to identify metabolites present in intervertebral discs colonized by C. acnes from patients with low back pain and degenerative disc disease, correlating them with their clinical, radiological and demographic profiles.
Effectiveness of Dry Needling in Patients With Chronic Nonspecific Low Back Pain
Low Back PainLow back pain is a major health problem that affects psychosocial, economical, functional and physical aspects of the patients' life. The aim of this study will be to investigate the effectiveness of dry needling on pain, functional disability, postural control and pain pressure threshold in patients with chronic nonspecific low back pain using a randomized controlled trial design. Patients with chronic nonspecific low back pain will be randomly divided into two groups: Experimental group (dry needling and routine physical therapy) and control group (sham dry needling and routine physical therapy). Primary outcomes will be pain intensity and functional disability. Postural control and pain pressure threshold will be considered as secondary outcomes.