Status:
UNKNOWN
MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
Lead Sponsor:
National University of Natural Medicine
Conditions:
Lumbar Radiculopathy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
INTRODUCTION: Chronic low back pain (CLBP) is a ubiquitous musculoskeletal (MSK) complaint that often presents as a chronic and difficult to treat condition. Lumbosacral radiculopathy/radiculitis (LR)...
Eligibility Criteria
Inclusion
- 1: Presence of previous diagnosis of LR
- 1a: Presence of lumbosacral radiculopathy/radiculitis symptoms that extend below the knee secondary to low back pain for greater than 6 weeks with a painDETECT score greater than 18 OR.
- 1b: Diagnosis of lumbosacral radiculopathy/radiculitis secondary to low back pain that extends below the knee, with symptoms present for greater than 6 weeks.
- 1b.1: ICD-10 codes used for diagnostic inclusion: M54.16, M54.17, M51.16, M51.17, M47.26, M47.27, M54.40, M54.41, M54.42, M99.53, M99.54, S34.21, S34.22, G54.4, and G55
- 2: At least 18 years of age and not older than 64 at the time of study enrollment.
- 3: Ability to read and understand English.
- 4: Willingness to be randomized to either an experimental or a control group.
- 5: Willingness to refrain from unnecessary or self-directed pain management/treatment plan changes during study enrollment and to report necessary changes made.
- 6: Daily access to the internet via cell phone, tablet, or computer.
Exclusion
- Epidural steroid injection in the prior 3 months.
- Inability to complete 20 unassisted gait cycles.
- Have received a surgical intervention for low back pain or lumbosacral radiculopathy/radiculitis within the previous 6 months.
- Current active mindfulness meditation practice: 1 time/week or more and/or formal training in mindfulness/meditation practice.
- Concurrent diagnosis of cancer.
- Allergy or intolerance to adhesive.
- Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia and schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04818606
Start Date
February 1 2021
End Date
March 1 2022
Last Update
March 26 2021
Active Locations (1)
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1
National University of Natural Medicine Helfgott Research Institute
Portland, Oregon, United States, 97201