Clinical trial NCT04818606: MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
Official title: Mindfulness-Oriented Recovery Enhancement in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: lumbar radiculopathy
Mindfulness Oriented Recovery Enhancement(MORE)
mindfulness
integrative and complementary health
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control Group = treatment as usual (TAU) Intervention Group = 8-week virtual mindfulness session
Primary purpose: TREATMENT

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) or "sciatica" is a common secondary condition that can last well beyond the expected time frame after treatment with physical therapy, oral anti-inflammatory medications, local steroidal injections, and surgery. Challenges in the treatment of LR indicate that persistent pain may have evolved from mechanical to neuropathic. Previous research has shown that, in addition to the aforementioned treatments, mindfulness-based stress reduction (MBSR) is effective in limiting self-reported pain in patients with CLBP and neurogenic conditions such as fibromyalgia. This study proposes a randomized clinical trial to evaluate the effects of a newer mindfulness program, Mindfulness Oriented Recovery Enhancement (MORE), on self-reported pain, physical function, quality of life (QoL), depression symptoms, trait mindfulness, reinterpretation of pain, and surface electromyography (sEMG) findings in patients with LR.

METHODS: Participants will be recruited from the Portland, OR metro area. Upon screening and recruitment, participants will receive a battery of questionnaires collecting demographic, self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain data. Participants will also undergo sEMG to identify neurological abnormalities that can be characterized diagnostically. Upon enrollment, participants will be randomized to either the mindfulness-based intervention group (MBI), MORE; or the control group, treatment as usual (TAU), for 8 weeks. Self-reported pain measures and sEMG studies will be conducted again at eight weeks post randomization.

HYPOTHESES: Primarily, investigators hypothesize that MORE will be effective in improving self-reported pain, physical function, QoL, depression symptoms, mindfulness, and reinterpretation of pain scores after eight weeks of mindfulness training. Secondarily, investigators hypothesize that those individuals with abnormal sEMG findings at baseline will have improved sEMG findings at their eight-week follow-up visit.

ANALYSIS PLAN: Changes in self-reported pain, physical function, QoL, depression symptoms, trait mindfulness, and reinterpretation of pain will be analyzed using descriptive statistics as well as ANCOVA. Regression will also be used to evaluate the dose-response relationship between all outcome measures and time spent in mindfulness practice for the intervention group. Finally, ANCOVA will be used to evaluate the relationship between pain and physical function and sEMG findings.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

1. Epidural steroid injection in the prior 3 months.
2. Inability to complete 20 unassisted gait cycles.
3. Have received a surgical intervention for low back pain or lumbosacral radiculopathy/radiculitis within the previous 6 months.
4. Current active mindfulness meditation practice: 1 time/week or more and/or formal training in mindfulness/meditation practice.
5. Concurrent diagnosis of cancer.
6. Allergy or intolerance to adhesive.
7. Current unmanaged or uncontrolled mental illness known to cause psychosis: schizophrenia and schizotypal disorders, bipolar I disorder with psychosis, major depressive disorder with psychosis.

Primary outcomes:
measure: Change in Modified Oswestry Low Back Pain Disability Questionnaire Score
timeFrame: Change from Baseline to 8-Week Follow-Up
Secondary outcomes:
measure: Change in painDETECT Questionnaire Score
timeFrame: Change from Baseline to 8-Week Follow-Up
measure: Change in Visual Analog Scale Score
timeFrame: Change from Intervention Week 1 to Intervention Week 8
measure: Change in SF-12 Patient Questionnaire for Quality of Life Score
timeFrame: Change from Baseline to 8-Week Follow-Up
measure: Change in Major Depression Inventory Score
timeFrame: Change from Baseline to 8-Week Follow-Up
measure: Change in Five Facet Mindfulness Questionnaire Score
timeFrame: Change from Baseline to 8-Week Follow-Up
measure: Change in Mindful Reinterpretation of Painful Sensations Scale Score
timeFrame: Change from Baseline to 8-Week Follow-Up
measure: Change in Surface Electromyography RMS and RMS peak time
timeFrame: Change from Baseline to 8-Week Follow-Up
Other outcomes:
Locations:
city: Portland
country: United States
facility: National University of Natural Medicine Helfgott Research Institute
state: Oregon
Study officials:
affiliation: National University of Natural Medicine
name: Courtney "Katie" Pickworth, ND, MS
role: PRINCIPAL_INVESTIGATOR
References: