Clinical Trials Logo

Low Back Pain clinical trials

View clinical trials related to Low Back Pain.

Filter by:

NCT ID: NCT05419297 Recruiting - Chronic Pain Clinical Trials

True Functional Restoration and Analgesia in Non-Radicular Low Back Pain

Start date: August 3, 2022
Phase: Phase 4
Study type: Interventional

To study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV design. To assess associations between traditional pain relevant subjective outcomes and objective or quasi-objective functional outcomes; In a small 'n' construct, to assess more powerful, 'new' statistical methods (e.g. hierarchical linear models, joint trajectory analysis) compared to traditional methods, in the context of increased power, more objective outcomes and cost savings. First a 2-week washout of any opioid medication (if necessary; if not necessary subject can proceed directly to); baseline week (Single Blind Placebo Lead In (SBPLI), using the placebo film resembling the 150mcg dose; then randomization to a ~ 2 week up titration either to effective Buprenorphine Buccal Film (BBF) dose 2 day average pain better than or equal to 3/10 NRS), highest tolerated dose BBF and/or maximum dose BBF of 900 mcg BID, or identical placebo material up to these parameters. This up titration is at the discretion and timing of the blinded and experienced PI. Subject will be allowed two doses of hydrocodone/acetaminophen 5/325 daily during the washout period. A single experienced practitioner will manage the titration as to safety, detail and timing; and determine when the subject enters the 8 week stable dose trial; this practitioner will remain blinded throughout unless there is an urgent, safety reason for unblinding

NCT ID: NCT05409443 Recruiting - Low Back Pain Clinical Trials

Conventional vs Bipolar SIJ RFA for Treatment of Sacroiliac Joint Pain

Start date: August 15, 2022
Phase: Phase 4
Study type: Interventional

Specific Aims The sacroiliac joint complex (SIJC) is a diathrodial, synovial joint and posterior ligamentous network that receives both anterior innervation from the lumbosacral plexus as well as posterior sensory innervation via the posterior sacral network (PSN). The PSN is comprised by the lateral branches S1-S3 posterior rami, with variable contributions from S4 lateral branch, L4 medial branch, and L5 dorsal ramus. Pain signals originating from the SIJC can be interrupted with image-guided percutaneous radiofrequency ablation (RFA) of the PSN, thereby reducing pain and disability in carefully selected patients. A prior systematic review estimated that 32-89% of patients achieve at least 50% pain relief for six months after some type of PSN ablation. Many experts suspect that heterogenous RFA techniques and technology are responsible for the variable success rates seen across published studies. Cadaveric work suggests that targeting the PSN with a large bipolar strip lesions would result in >95% PSN neural capture compared to a smaller lesion produced by a conventional, monopolar, periforaminal RFA technique which may capture as low as 2.5% of the PSN. Nimbus is a commonly used multi-tined RFA probe whose large bipolar lesion size make it an ideal option for complete PSN neural ablation. Both the Nimbus (N-SIJRFA) and conventional (C-SIJRFA) techniques and technologies are commonly used; however, there are no prospective RCT's comparing them, and the clinical significance remains unknown. Problem: There are no randomized controlled trials comparing novel technologies like N-SIJRFA to C-SIJRFA. Purpose: To compare pain and disability outcomes in patients with confirmed SIJC pain after randomization to either N-SIJRFA or C-SIJRFA. Central Hypothesis: N-SIJRFA will be more effective in improving pain and function compared to patients treated with C-SIJRFA at 3, 6, 12, 18, and 24 months. Specific Aims: 1. Compare the proportion of participants who report ≥50% relief of pain by Numeric Pain Rating Scale (NPRS) after N-SIJRFA versus C-SIJRFA. 2. Compare the proportion of participants who report ≥15-point ODI (Oswestry Disability Index) reduction after N-SIJRFA versus C-SIJRFA. 3. Compare the proportion of participants with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03, after N-SIJRFA versus C-SIJRFA. 4. Compare the proportions of participants who report being "improved" or "much improved" on the Patient Global Impression of Change (PGIC) scale after N-SIJRFA versus C-SIJRFA. 5. Evaluate the differences in success rates for pain improvement, functional improvement and satisfaction in those experiencing ≥ 50%, ≥ 80%, and 100% pain relief after either prognostic PSN blocks or intra-articular (IA) sacroiliac joint (SIJ) injections. 6. Determine the effect of PSN ablation on reducing pain related sleep disturbance as measured by the Pain and Sleep Questionnaire (PSQ-3). 7. Compare procedural time requirements between those treated with N-SIJRFA versus C-SIJRFA. 8. Report adverse effects. 9. Report rates of subsequent interventional healthcare utilization including repeat N-SIJRFA versus C-SIJRFA, SIJ injection, and SIJ fusion.

NCT ID: NCT05405127 Recruiting - Low Back Pain Clinical Trials

Breathing and Core Stability Exercise Effects on Lumbopelvic Pain

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

Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index.

NCT ID: NCT05404997 Recruiting - Clinical trials for Mechanical Low Back Pain

Comparative Effects of SWT and Maitland LM in Mechanical LBP

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

Low back pain is a common neuro-musculo-skeletal problem affecting 40% of world's population at some point in their life and causes significant disability with loss of productive working hours. Low back pain is usually non-specific or mechanical and its mechanical origin is identified by the presence or absence of signs and symptoms i-e local or radicular pain, tenderness, spasm associated with different postures or movements. This study aims to compare the therapeutic effects of shockwave therapy and Maitland lumbar mobilizations on pain, disability and range of motion in patients having mechanical low back pain. Current study will be randomized clinical trial in which convenience sampling technique will be used. Sample size will be 26. Subjects with age group of 25 to 45 years and who meet the inclusion and exclusion criteria will be included in this study and they will be randomly allocated into two groups. Group A will be given shockwave therapy treatment, while the group B will be given Maitland lumbar PA glide mobilizations. Each groups will also receive the conventional physical therapy treatment that includes lumbar stretching exercises and core strengthening exercises. Both the therapeutic techniques will be conducted for 4 weeks, two sessions per week for each group. Before, after two weeks and after four weeks of the treatment sessions, effects of treatment will be noted and quantitative data will be analyzed using SPSS software version 25.

NCT ID: NCT05404854 Recruiting - Clinical trials for Chronic Low-back Pain

Evolution of Physical Activity, Sedentary Behavior and Associated Motivations After Rehabilitation for Chronic Low Back Pain Patients

LOMB'ACTIV
Start date: August 22, 2022
Phase:
Study type: Observational

IIn 2016, chronic low back pain (CLBP) was the leading cause of years lived with disability worldwide. This condition impacts social interactions, work life, and can lead to an altered quality of life for patients. For these patients, physical activity (PA) can reduce pain, improve function and the rate of return to work. According to the French National Authority for Health, it is the main treatment in the management of these patients. Nevertheless, the literature reports PA levels that are relatively comparable to those of the general population. Considering that a large proportion of adults struggle to meet these thresholds, we can infer that the same is true for CLBP patients. In addition to PA, the World Health Organization recommends that all adults should limit the amount of time spent in sedentary behaviors. Thus, CLBP patients should adopt an active lifestyle, characterized by regular PA and limited sedentary behaviors (SB). In view of these elements, it is essential to implement dedicated interventions. The literature reports mixed results with work focused on PA promotion. No study has focused on i) the reduction of CS, ii) the rehabilitation programs (RP) proposed in France. On the other hand, there is a need to better understand what determines engagement in such behaviors. Among these determinants are several psychological variables related to behavioral intentions. A recent line of research indicates that beyond these motivational dimensions, which are explicit in nature, certain implicit processes are significantly associated with the adoption or non-adoption of certain health-related behaviors. This result has been observed in the context of chronic disease (respiratory patients, metabolic patients) but remains unexplored in patients with chronic low back pain. The aim of this study is to simultaneously question these different aspects: the effects of a RP on changes in PA and CS, in relation to motivational changes in a population of CLBP patients.

NCT ID: NCT05402631 Recruiting - Back Pain Clinical Trials

Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain?

Start date: April 20, 2022
Phase:
Study type: Observational

Investigators hypothesize that patients with higher expectations regarding their epidural injection experience a higher pain reduction of their lower back pain and/or leg pain after an epidural injection. Patients' expectations of an epidural injection can influence their level of pain reduction. The primary objective of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections ('expected benefits', see under) in patients with low back pain and/or leg pain. Investigators furthermore hypothesize that patients that have a higher match between their expectations of improvement and actual improvement are more satisfied. A secondary objective of this study is to investigate the prognostic significance of a high match between expectations of improvement and actual improvement on patient satisfaction of the treatment.

NCT ID: NCT05390762 Recruiting - Low Back Pain Clinical Trials

Telecare Rehabilitation Program in Chronic Low Back Pain With Psychological Retention and Predominant Sociability

TELELOMB
Start date: May 3, 2022
Phase: N/A
Study type: Interventional

The present study proposes to evaluate the impact of a multidisciplinary biopsychosocial Telecare rehabilitation program at the functional level in people with chronic low back pain with major psycho-behavior maintenance. The hypothesis is that a personalized program combining remote psycho-professional and physical care by digital tools improves functional evaluation in these patients.

NCT ID: NCT05384457 Recruiting - Chronic Pain Clinical Trials

High Intensity Training to Improve Diaphragm Functioning in Persons With Chronic Nonspecific Low Back Pain

Start date: August 22, 2022
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to investigate 1) the effects of high intensity training (HIT) compared to moderate intensity training (MIT) on diaphragm muscle strength, -endurance, -fatigue and -activation, 2) to which extent these changes in diaphragm functioning are related to changes in cardiorespiratory fitness, postural control, pain and disability after HIT versus MIT, 3) to which extent depressive mood and anxiety moderate the effects of HIT on diaphragm functioning in persons with chronic nonspecific low back pain (CNSLBP). The investigators hypothize that HIT improves diaphragm functioning more compared to MIT in persons with CNSLBP.

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: NCT05360121 Recruiting - Low Back Pain Clinical Trials

Muscle Energy Technique Versus Back Stretching Among Non-specific Low Back Pain-subacute

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

This study will highlight LBP management using MET and stretching application among subacute type of back pain