View clinical trials related to Chronic Low Back Pain.
Filter by:A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments. The primary objective of this study is to determine the rate of re-operations at the index level(s). The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
The overall objective of this study is to develop and test an efficient set of self-report instruments to measure Complementary and Alternative Medicine(CAM)-relevant contextual factors important in healing. The initial phase of the study involves developing and refining an item bank. During the initial 'item bank development' phase, the investigators will run focus groups and cognitive interviews with individuals who participate in CAM and conventional medicine interventions. The next step of instrument development is called Calibration, and involves administering the revised item bank to an internet sample and to persons who receive services in a CAM clinic and a conventional primary care setting. The items will be calibrated using item response theory and classical test theory. This will result in a computerized adaptive testing version of the instrument, as well as a static short form of the instrument. This current protocol in ClinicalTrials.gov pertains only to the final, Validation Phase of the study. The final phase of the project will involve conducting initial validation studies of the set of instruments. The set of instruments will be called the Healing Encounters and Attitudes Lists (HEAL). The investigators will evaluate the convergent, discriminant, and predictive validity of the HEAL instruments in a sample of 200 persons with chronic low back pain or neck pain who are receiving physical therapy, chiropractic care, acupuncture, medical management, or mindfulness-based stress reduction. For convergent validity, the HEAL is expected to display moderate to large correlations with measures of similar constructs. The HEAL is expected to correlate modestly with self-report measures of general psychosocial functioning, in support of discriminant validity. Finally, HEAL scores should account for a significant proportion of the variance in treatment outcome, supporting predictive validity.
The purpose of this study is to evaluate whether individual cognitive functional therapy (CFT), when compared to group exercise classes is effective in reducing pain and disability in patients with non-specific chronic low back pain.
Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.
Non-specific chronic low back pain guidelines recommend rehabilitation along with a biopsychosocial approach. However, though psychological and social issues address important needs of professionals and patients, they have been scarcely developed in this area so far. Noteworthy, little is known about patients' expectations relative to physiotherapy for chronic low back pain (CLBP), while professional recommendations advocate taking them into consideration. A study about patients' experience will provide knowledge about the ill person's perspective and how the physiotherapists are perceived as well as the role attributed to them. The aim of this study is, thus, to explore the experience of the patients suffering from CLBP in order to highlight their expectations toward physiotherapy services and physiotherapists. The investigators will apply a critically interpretive socio-anthropological approach based on patients' interviews and observations in an intensive CLBP rehabilitation program. The results will help improve the care patients receive by facilitating the integration of biopsychosocial issues related to patient's expectations into the treatment.
The purpose of this study is to compare two kinds of self-administered acupressure (relaxation acupressure and stimulating acupressure) to usual care for management of fatigue and pain in low back pain patients. Hypothesis: Self-administered relaxation acupressure will result in improvements in fatigue and sleep quality, pain, and physical function compared to stimulating acupressure and usual care.
The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.
The goal of this randomized clinical study is to assess pain and dysfunction in 225 volunteer subjects who have chronic low back pain. The hypothesis of this study is that custom-made shoe will improve patients' low back pain and dysfunction. Additionally, custom-made shoe orthotics plus chiropractic treatment will further improve patients' low back pain and dysfunction while maintaining that improvement during the one year study follow-up period. Specific Aims: 1. To determine the changes in perceived pain levels (Numeric Pain Rating Scale) and dysfunction (Oswestry Disability Index) in patients with chronic low back pain after six weeks of custom-made shoe orthotic use with or without chiropractic care as compared to no care. 2. To determine the changes in perceived pain levels and dysfunction in patients with chronic low back pain after twelve weeks of custom-made shoe orthotic use. 3. To determine the changes in perceived pain levels and dysfunction at 3, 6, and 12 months following the 12 week treatment period.
Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain. Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used. Hypothesis - abdominal belt will improve pain in chronic low back pain patients
The main objective of this study is to compare on day 0 the maximum Lyapunov exponent (lmax, an indicator of local dynamic stability) of chronic low back pain patients versus that of healthy volunteers matched for age (± 5 years), sex and body mass index (BMI ± 15% of low back pain patients).