Clinical trials: Lumbar Pain
Low Back Pain
A Prospective Study of the InterFuse T(tm),
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
- Trial name
- NCT02678130
- Testing
- InterFuse T, Standard of Care TLIF (Stryker AVS Unilif)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Vertebral Technologies, Inc.
Chronic Pain, Knee Pain Chronic
HFIT Versus TENS Study for Chronic Low Back and Knee Pain
A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain.
- Conditions
- Chronic Pain, Knee Pain Chronic, Back Pain, Low
- Trial name
- NCT05821530
- Testing
- HFIT, TENS, Control
- Where
- United States
- Volunteers
- 325 people
- Sponsor
- Hinge Health, Inc
Pain, Low Back Pain
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain.
- Trial name
- NCT01431742
- Testing
- BEMA Buprenorphine
- Where
- United States
- Sponsor
- BioDelivery Sciences International
Chronic Low Back Pain
Clinical Investigation to Assess the Clinical Performance of the LumbaCure® Intervention on Chronic Low Back Pain Patients.
Low Back Pain (LBP) is one of the common causes of morbidity worldwide, with a one-month prevalence of 23.3 %. Number of people with LBP reached 577 million people in 2020.
- Trial name
- NCT06138002
- Testing
- LumbaCure®, Physical Exercises supervised by the physiotherapist
- Where
- 2 sites in Belgium
- Volunteers
- 22 people
- Sponsor
- Odix
Lumbar Disc Herniation, Annular Disc Tear
A Post Marketing Surveillance Study
This study is a prospective, multi-center study to monitor the early safety and performance of one iteration of the Barricaid Anular Closure Device (ACD) - 6mm anchor width, when used as an adjunct to limited discectomy.
- Conditions
- Lumbar Disc Herniation, Annular Disc Tear, Annular Tear of Lumbar Disc
- Trial name
- 6MM (NCT03366779)
- Testing
- 6mm annular closure device
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 20 people
- Sponsor
- Intrinsic Therapeutics
Low Back Pain, Neuropathic Pain
Comparison of Increasing Doses of Tapentadol Versus a Combination of Tapentadol and Pregabalin
The main objective of the study is to evaluate the effectiveness, safety, and tolerability of increasing doses of tapentadol prolonged release (PR) (500 mg per day) versus a combination of tapentadol PR (300 mg per day) and…
- Trial name
- NCT01352741
- Testing
- Tapentadol Prolonged Release, Tapentadol Prolonged Release with Pregabalin, Tapentadol Prolonged Release open label maintenance
- Where
- 59 sites in Austria, Belgium and 5 more
- Volunteers
- 622 people
- Sponsor
- Grünenthal GmbH
Back Pain
Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain
The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure.
- Trial name
- COLD (NCT01263054)
- Testing
- TransDiscal System, Medical Management
- Where
- 9 sites in United States
- Volunteers
- 67 people
- Sponsor
- Halyard Health
Painful Lumbar Radiculopathy, Sciatica
BG00010 (Neublastin) Phase 2 Multiple Dose Adaptive Design in Participants With Painful Lumbar Radiculopathy
The primary objective of the study is to assess the efficacy of Intravenous (IV) BG00010 (Neublastin) in improving pain in painful lumbar radiculopathy participants when administered 3 times per week for 1 week.
- Conditions
- Painful Lumbar Radiculopathy, Sciatica, Radiculopathy
- Trial name
- SPRINT (NCT01873404)
- Testing
- BG00010
- Where
- 25 sites in United States
- Volunteers
- 183 people
- Sponsor
- Biogen
Chronic Low Back Pain
Digital Therapeutics (DTx) for Pain: Pilot Study of a Virtual Reality Software for Chronic Pain
Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.
- Trial name
- VIRPI (NCT04225884)
- Testing
- DTx for pain software, Control software, Standard care
- Where
- Finland
- Volunteers
- 34 people
- Sponsor
- Orion Corporation, Orion Pharma
Low Back Pain
Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery.
- Trial name
- NCT02293525
- Testing
- ReLeaf catheter, Ropivacaine, Saline
- Sponsor
- Vital 5, LLC
Chronic Low Back Pain
ReActiv8 Post Market Surveillance Registry
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.
- Trial name
- ReActiv8-C (NCT03255200)
- Testing
- ReActiv8 Implantable Stimulation System
- Where
- 5 sites in Germany
- Volunteers
- 87 people
- Sponsor
- Mainstay Medical
Osteoarthritis, Rheumatoid Arthritis
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT01961271
- Testing
- Buprenorphine transdermal patch
- Where
- 16 sites in Hong Kong, Philippines and 1 more
- Volunteers
- 114 people
- Sponsor
- Mundipharma Pte Ltd.
Lower Back Pain
E-STIM Trial: Comparing the Efficacy of the Empi Select TENS to a Control for the Treatment of Chronic Lower Back Pain
The purpose of this study is to determine whether transcutaneous electrical nerve stimulation (TENS) delivered via the Empi Select TENS device provides relief of chronic lower back pain.
- Trial name
- E-STIM (NCT00709748)
- Testing
- Empi Select TENS Device
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Empi, A DJO Company
Chronic Non-specific Low Back Pain
Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic…
- Trial name
- NCT04940741
- Testing
- VER-01
- Where
- Germany
- Volunteers
- 820 people
- Sponsor
- Vertanical GmbH
Back Pain
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms
The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.
- Trial name
- NCT00817986
- Testing
- Arbaclofen placarbil, 20 mg, Arbaclofen placarbil, 30 mg, Arbaclofen placarbil, 40 mg
- Where
- 20 sites in United States
- Volunteers
- 161 people
- Sponsor
- XenoPort, Inc.
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
Facet Joint Pain
ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain
The study is a single ascending dose (SAD), single-center, randomised, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 in…
- Trial name
- NCT07520240
- Testing
- ITX24-01, Normal Saline (0.9% NaCl)
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Interventional AnalgesiX Inc.
Ulcer
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450216
- Testing
- Ibuprofen/famotidine, Ibuprofen
- Volunteers
- 906 people
- Sponsor
- Amgen
Osteoarthritis, Pain
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
- Trial name
- NCT00426647
- Testing
- Buprenorphine, Tramadol
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- Norpharma A/S
Lumbar Disc Herniation
Barricaid EU Post Market Study for Primary Lumbar Disc Herniation
The purpose of this multi-center post marketing surveillance study is to monitor the safety and performance of the Barricaid® ARD when used to surgically reconstruct the anulus of the L1 - S1 spinal disc.
- Trial name
- NCT01534065
- Testing
- Barricaid
- Volunteers
- 45 people
- Sponsor
- Intrinsic Therapeutics