Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525896
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Non-surgical Spinal Decompression Therapy and Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Research on Effectiveness of Non-surgical Spinal Decompression Therapy and Outcomes With Radiographic Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
Brief Summary:
This project will determine the clinical utility of non-surgical spine decompression for chronic low back pain LBP LBP is one of the highest incidence medical conditions that contributes to disability decreased activities of daily living decreased quality of life and inability to work LBP affects 70-85 of people during their lifetime with 20 becoming chronic by age 20-59 years Many current LBP therapeutics have detrimental long-term effects undesired side effects are invasive procedures with low success rates and do not fare better than conservative care Further many chronic musculoskeletal pain patients do not respond to surgery and many develop dependence on opioids
This project will implement a small-scale double-blinded randomized proof-of-concept clinical trial to gather biomechanical and MRI data that will objectively determine the effectiveness of non-surgical spinal decompression NSSD over a 12-week longitudinal timeframe The potential to provide a non-invasive alternative to chronic LBP via NSSD is innovative and addresses the pressing need for safer more effective pain management options with fewer negative sequelae NSSD has the potential to greatly improve lives offering a new paradigm for chronic pain management
This project will implement a small-scale double-blinded randomized proof-of-concept clinical trial to gather biomechanical and MRI data that will objectively determine the effectiveness of non-surgical spinal decompression NSSD over a 12-week longitudinal timeframe The potential to provide a non-invasive alternative to chronic LBP via NSSD is innovative and addresses the pressing need for safer more effective pain management options with fewer negative sequelae NSSD has the potential to greatly improve lives offering a new paradigm for chronic pain management
Detailed Description:
Participants who consent to the study will undergo a comprehensive baseline assessment
Baseline During this visit the patient will receive a chiropractic physician examination that will include reflexes myotome dermatome and orthopedic assessments If the examination provides evidence of an intervertebral disc pathology andor sciatica the patient will be referred to an MRI assessment to confirm diagnosis for standard of care Based on these assessments the research team will determine if the participant meets the initial criteria to continue with participation
Randomization Participants will be randomized to either non-surgical spinal decompression 20 treatments or placebo 20 treatments Participants will not be able to choose the treatment The participant nor the investigators will know which treatment you are receiving If a participant receives the placebo treatment once they are unblinded they will be able to receive non-surgical spinal decompression should they elect to do so
Pre-intervention Assessments Assessments prior to intervention will include 1 3D motion capture performing functional tasks 2 electromyography of the lower back and legs 3 myotonometer tonometry 4 range of motion and 5 Sensorimotor reflex measurement In addition the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 20 PROMIS Pain Interference PROMIS Physical Function Central Sensitization Inventory and the Oswestry Disability Index
Post-intervention Assessments Assessments after intervention will include 1 3D motion capture performing functional tasks 2 electromyography of the lower back and legs 3 myotonometer tonometry 4 range of motion and 5 Sensorimotor reflex measurement In addition the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 20 PROMIS Pain Interference PROMIS Physical Function Central Sensitization Inventory and the Oswestry Disability Index
Baseline During this visit the patient will receive a chiropractic physician examination that will include reflexes myotome dermatome and orthopedic assessments If the examination provides evidence of an intervertebral disc pathology andor sciatica the patient will be referred to an MRI assessment to confirm diagnosis for standard of care Based on these assessments the research team will determine if the participant meets the initial criteria to continue with participation
Randomization Participants will be randomized to either non-surgical spinal decompression 20 treatments or placebo 20 treatments Participants will not be able to choose the treatment The participant nor the investigators will know which treatment you are receiving If a participant receives the placebo treatment once they are unblinded they will be able to receive non-surgical spinal decompression should they elect to do so
Pre-intervention Assessments Assessments prior to intervention will include 1 3D motion capture performing functional tasks 2 electromyography of the lower back and legs 3 myotonometer tonometry 4 range of motion and 5 Sensorimotor reflex measurement In addition the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 20 PROMIS Pain Interference PROMIS Physical Function Central Sensitization Inventory and the Oswestry Disability Index
Post-intervention Assessments Assessments after intervention will include 1 3D motion capture performing functional tasks 2 electromyography of the lower back and legs 3 myotonometer tonometry 4 range of motion and 5 Sensorimotor reflex measurement In addition the participant will complete online questionnaires that include the Defense Veterans Pain Rating Scale 20 PROMIS Pain Interference PROMIS Physical Function Central Sensitization Inventory and the Oswestry Disability Index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None