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Low Back Pain clinical trials

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NCT ID: NCT05115227 Completed - Low Back Pain Clinical Trials

Long-term Multidisciplinary Team-based Management of Back Pain

TeamBack
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Long-term approaches are challenging to implement within the current care system, which rewards clinicians for attempting to quick-fix a long-term condition. This results in increased inappropriate imaging, opioid prescriptions, surgery, and visits/rehabilitation in secondary care, leading to higher societal costs and the continuing increase of LBP-related disability that is currently observed. The investigators argue that LBP management can be optimized by providing patients with self-management strategies supported by a multidisciplinary team and providing simple, safe, and low-cost interventions that adhere to clinical guidelines. This has the potential to change patient behaviors and facilitate empowerment to self-manage LBP leading to lower societal costs of LBP. Research objectives The investigators will develop and test a long-term supportive multidisciplinary team-based management strategy with a specific focus on communicating a structured and unchanging message about individualized diagnosis, treatment, and prognosis, focusing on conducting a large randomized controlled trial as the next phase. This feasibility trial will be completed in a secondary care settings, where relevant patients with poor management skills and insufficient effects of usual (primary) care management can be identified. The specific objectives are: (I) To develop a long-term supportive multidisciplinary team-based management strategy for secondary-care low back pain patients (II) To test the feasibility by assessing: - Changes in relevant outcomes - Utilization of Primary care - Patients and clinicians experience with the intervention - Practical challenges of the setting The management strategy development follows the principles provided by the Medical Research Council for developing complex interventions. Development of the framework Step 1: Framework setup The investigators constructed a basic framework for the intervention by reviewing relevant systematic reviews and clinical guidelines. The research group determined the initial management intervention. Afterward, the investigators conducted a small survey on 191 participants (11% of the total sample of patients between February and May 2021), about their interest in participating. The majority would find such an approach of interest (147(77%)). In parallel, the investigators conducted short semi-structured interviews concerning the intervention with a convenient sample of 20 patients. Seventeen provided usable data. Step 2 - Development Using the participants' information, the investigators re-framed the management strategy. Subsequent semi-structured focus-group interviews with a clinical panel for further modifications before testing was conducted. Step 3 - Feasibility The multidisciplinary team for the feasibility trial consists of two coordinators (chiropractors), two therapists (physical therapists), one medical doctor, and one nurse. The feasibility trial aims to identify and develop the appropriate framework by: I) Investigating the patients' experiences of the current management strategy II) Ensuring satisfactory work-relations between clinicians III) Determining the primary outcome IV) Mapping the multiple interacting components of the management strategy V) Investigating how to measure parallel use of primary care and how this could be applied in the trial evaluation VI) Estimating the workload (number of hours) of the clinicians VII) Quantifying any out-of-protocol behaviors by clinicians and patients alike VIII) Quantifying the different aspects of the intervention using the clinical records The feasibility trial will include 25 LBP patients from the Spine Centre willing to participate in a limited three-month follow-up. The intervention procedure is: 1) A team meeting will be held each morning where the coordinator and the feasibility team will go through the patients. This will start the initial sparring process to ensure a structured and unchanging message for the patient. The coordinator will first assess each patient face-to-face according to ICD-10 principles and enroll eligible patients in the trial. Afterward, the therapist will evaluate the patient's current functional status and management strategy. During the three months, patients will have multiple encounters with the coordinator, the therapist, and the nurse, if needed. The therapist will provide further interventions (e.g., exercise and cognitive/behavioral therapy) to encourage self-management. The investigators will assess the following outcomes at three months: Disability (primary), pain, self-efficacy, quality of life, LBP trajectory, workability, and work retention.

NCT ID: NCT05106920 Completed - Low Back Pain Clinical Trials

Frequency Parameter Used to Apply Ultrasound-guided Neuromodulation Percutaneous

Parameters NMP
Start date: November 3, 2021
Phase: N/A
Study type: Interventional

In the daily clinical practice, one of the most frequent reasons for consultation physiotherapists is low back pain (LBP). Regardless of the origin of the problem, the approach from physiotherapy contemplates the reduction of pain through different procedures, including neuromodulation. In the field of Physiotherapy, ultrasound-guided Percutaneous Neuromodulation (PNM) is defined as the application through a needle with ultrasound guidance of an electrical current at low or medium frequency, seeking a sensitive and / or motor response of a peripheral nerve in some point of its trajectory, or of a muscle in a motor point, with a therapeutic objective. The objective of the study is to analyze that the effect of PNM on the sciatic nerve produces statistically significant changes in pain, joint range and functionality in patients with chronic LBP. Forty subjects will be recruited, which will be divided into 2 groups: group 1 to which PNM will be applied to the sciatic nerve at 250 microseconds, 3 Hz) during 90 seconds; group 2 to which PNM will be applied to the sciatic nerve in at 250 microseconds, 10 Hz during 90 second. The PNM intervention with NMP will consist in the single application of an asymmetric rectangular biphasic current.

NCT ID: NCT05104957 Completed - Low Back Pain Clinical Trials

Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain

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

Lumbar spine pain syndromes are one of the most common pain conditions in our society. The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications. There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.

NCT ID: NCT05103475 Completed - Clinical trials for Chronic Low Back Pain

Rage Against the Pain

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

Low back pain is a leading cause of disability among US adults, and can drive opioid use and associated poor outcomes. The Veterans Health Administration (VA) considers low back pain a significant problem. Yoga is recommended as a front-line treatment for low back pain, however, Veteran participation in yoga is low. One potential barrier to adoption among Veterans may be their perceptions of yoga. In an effort to increase Veteran use of yoga, the investigators will develop and test an alternative yoga program that may better meet Veteran preferences and interests. The investigators call this yoga program, Rage Against the Pain (RAP) 'High Intensity Stretching'. The RAP program will promote yoga as less of a meditative, introspective activity done to quiet calming music and more of an expressive, active practice set to music commonly enjoyed among many Veterans (e.g., rock, metal). The goal of this pilot study is to develop and evaluate the RAP program, including Veteran perceptions of and experiences with the program and how it may impact yoga participation, among Veterans with chronic low back pain.

NCT ID: NCT05103462 Completed - Low Back Pain Clinical Trials

Telehealth Physical Therapy for Chronic Back Pain - Ancillary Study to NCT03859713

TeleOPT
Start date: August 18, 2020
Phase: N/A
Study type: Interventional

This study evaluated the feasibility of an 8-week physical therapy program for persons with chronic low back pain provided entirely using telehealth with real-time, interactive video sessions with a physical therapist.

NCT ID: NCT05101200 Completed - Clinical trials for Non-specific Low Back Pain

Dose Response of Neural Mobilization on Hamstring Flexibility in Low Back Pain

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

This study will be a randomized control trial and will be conducted in Riphah International Hospital, National orthopedic and specialist hospital, Riphah international hospital and Chambeli institute of physiotherapy. A sample of 34 participants will be taken. Participants will be randomized into Group A and Group B through lottery method. Group A will receive High Dose Neural Mobilization Technique, Hot pack for 15 minutes, strengthening exercises with 10rep/8sets , strengthening exercises for quadriceps and static stretching exercise for hamstring with 10 rep/8sets, While Group B will receive Low Dose Neural Mobilization Technique with minimal intensity, hot pack: 15 minutes, strengthening exercises with 10rep/4sets. Both groups will be given session of 40 min/day, 2 days/week for 4 weeks, assessment will be done at baseline, at the end of 1st week, 2nd week, 3rd week & at the end of 4th week. The outcome measure will be Numeric Pain Rating Scale (NPRS), Oswestry Disability Index (ODI), Active Knee Extension test (AKE) and Lumbar flexion by Schober method. Data will be analyzed be SPSS 22.

NCT ID: NCT05099796 Completed - Low Back Pain Clinical Trials

Epidural Steroid Injections in Post-lumbar Surgery Syndrome After Single-level Discectomy

Start date: January 5, 2016
Phase: N/A
Study type: Interventional

62 patients with postlumbar surgery syndrome were randomized and divided into two groups. Transforaminal epidural steroid injection (TFESI) was applied to the TFESI group (n=31), and caudal epidural steroid injection (CESI) was applied to the CESI group (n=31). The age of the patients involved in this study ranged from 18 years old to 65 years old

NCT ID: NCT05097235 Completed - Clinical trials for Sensory Profiles, Nociplastic Pain, Low Back Pain

Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.

T3PredCohSt
Start date: May 1, 2022
Phase:
Study type: Observational [Patient Registry]

This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.

NCT ID: NCT05096494 Completed - Clinical trials for Moderate to Severe Acute Lower Back Pain

Safety and Efficacy of SP-103 in Subjects With Moderate to Severe Acute Lower Back Pain

Start date: April 29, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety and efficacy of SP-103 in subjects with moderate to severe acute lower back pain.

NCT ID: NCT05095402 Completed - Low Back Pain Clinical Trials

Biomechanics of Lumbar Region in Low Back Pain

Start date: April 19, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.