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Lumbar Spinal Stenosis clinical trials

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NCT ID: NCT01902979 Recruiting - Obesity Clinical Trials

The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial

SSPANLI
Start date: September 2013
Phase: N/A
Study type: Interventional

Obesity is one of the most important determinants of quality of life and function. People with lumbar spinal stenosis may be at increased risk of obesity given walking limitations. Spinal stenosis is a very common degenerative condition in people over 45. People with this condition have pain and numbness in the legs during walking, and therefore avoid physical activity. Lack of physical activity is related to weight gain and increased risk of chronic disease. Objective: The objective of this project is test a new e-health (online) pedometer and nutrition intervention aimed at promoting weight loss and increasing physical activity in overweight and obese individuals with spinal stenosis. Methods: The investigators will recruit 88 people with lumbar spinal stenosis who are overweight or obese. Half of these people will receive the 12-week intervention, and the other half will receive usual care (no intervention). In Weeks 1 and 6, people in the intervention group will meet with a Registered Dietitian and an Exercise Physiologist for personalized sessions. They will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips. The investigators will look to see whether people in the intervention group show greater change in physical activity, body composition and quality of life compared to the individuals who received usual care. Relevance: The increasing number of people with spinal stenosis represents a huge health care burden in Canada. This intervention could provide a new treatment option that would increase mobility, quality of life, and potentially alleviate the need for expensive treatments like surgery. E-health interventions provide an opportunity for patients to take an active role in their own health, and promote behaviour changes that will result in healthier Canadians less likely to access care in the future.

NCT ID: NCT01455805 Completed - Clinical trials for Degenerative Disc Disease

Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis

Start date: June 2012
Phase: N/A
Study type: Interventional

Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are several treatment options for LSS including physiotherapy, lumbar surgical decompression procedures such as laminectomy, Foraminotomy, Discectomy and more recently devices for interspinous distraction such as the XSTOP® and from May 2011 Minuteman™. Surgical decompression for LSS involves the removal of excess bone, ligament, and soft-tissue allowing more room for the nerves. The operation is usually preformed under general anaesthetic and with an average stay in hospital for 2-3 nights. Whereas the Minuteman™ implant is preformed as a day case under local or general anaesthetic and involves implanting the device into the space between two back bones to relieve pressure on the nerves and, therefore, pain in the legs. This is a multi centred (four sites) randomised controlled trial with a total sample of 50 participants after obtaining their informed consent. Participants will attend the pain clinic at the Hospitals for a baseline visit where they will be randomised with a ratio of 1:1 to receive either the Minuteman™ Interspinous interlaminar fusion Implant or standard surgical decompression for the treatment of lumbar spinal stenosis (LSS). Following randomisation arrangements will be made for the participant to receive the randomised treatment. If allocated to Minuteman™ Implant, the treatment will be conducted by the Pain Specialist identified at the site. If allocated to surgical decompression, the treatment will be conducted by the neuro/spinal-surgeon identified at the site. Participates will be followed up regularly for 60 months post implant to assess clinical efficacy, safety, participants function and quality of life of each treatment.

NCT ID: NCT01338766 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression

STRiDE
Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.

NCT ID: NCT01315145 Completed - Clinical trials for Lumbar Spinal Stenosis

MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

MiDAS III
Start date: March 2011
Phase: N/A
Study type: Interventional

This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.

NCT ID: NCT01156675 Terminated - Clinical trials for Lumbar Spinal Stenosis

Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.

NCT ID: NCT01082159 Completed - Clinical trials for Lumbar Spinal Stenosis

MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

Start date: February 2010
Phase: Phase 4
Study type: Interventional

This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.

NCT ID: NCT01076244 Completed - Clinical trials for Lumbar Spinal Stenosis

Vertos Mild - Post Market Patient Outcomes

Start date: February 2010
Phase: N/A
Study type: Interventional

This is a single-center study evaluating the outcomes of patients with painful lumbar spinal stenosis who were treated with the mild procedure (minimally invasive lumbar decompression. The patients will be followed for 6 months after the procedure.

NCT ID: NCT01067014 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery

Start date: February 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.

NCT ID: NCT01057641 Terminated - Clinical trials for Lumbar Spinal Stenosis

Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

NCT ID: NCT01053364 Active, not recruiting - Clinical trials for Lumbar Spinal Stenosis

Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis

Start date: January 2010
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis