MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial

NCT04818606 | Unknown DMC

• 1 other identifier: KP112720
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Keywords

lumbar radiculopathy; Mindfulness Oriented Recovery Enhancement(MORE); mindfulness; integrative and complementary health

Outcome Measures

Primary Outcomes (1)

• Change in Modified Oswestry Low Back Pain Disability Questionnaire Score

  The ODI is designed to assess the intensity of pain and the degree to which pain interferes with activities of daily living such as personal care, lifting, walking, sitting, etc.

  Change from Baseline to 8-Week Follow-Up

Secondary Outcomes (7)

• Change in painDETECT Questionnaire Score

  Change from Baseline to 8-Week Follow-Up

• Change in Visual Analog Scale Score

  Change from Intervention Week 1 to Intervention Week 8

• Change in SF-12 Patient Questionnaire for Quality of Life Score

  Change from Baseline to 8-Week Follow-Up

• Change in Major Depression Inventory Score

  Change from Baseline to 8-Week Follow-Up

• Change in Five Facet Mindfulness Questionnaire Score

  Change from Baseline to 8-Week Follow-Up

Study Arms (2)

Intervention (MORE) Group

EXPERIMENTAL

Participants randomized to the intervention group will undergo an eight-week mindfulness training program as instructed by MORE for the Treatment of Chronic Pain manual. This eight-week intervention will consist of weekly synchronous video conferencing sessions during which participants will be asked to follow along with a guided meditation read by the study lead and to engage in reflection and discussion exercises with other study participants. Participants will also be asked to complete weekly activities and daily mindfulness practices outside of weekly synchronous meetings. Pre-recorded guided meditations created by study personnel using scripts from the MORE manual will be provided to participants to facilitate their daily practice.

Other: Mindfulness Oriented Recovery Enhancement

Control Group

NO INTERVENTION

This group will undergo treatment as usual (TAU) over the course of the eight-week time period of parallel group comparison. This may or may not involve regularly scheduled, standard visits with other medical personnel, including primary care, specialized medical services, or complementary and integrative health practitioners (e.g., acupuncture). Participants will be asked to refrain from altering therapeutic approaches to pain management during this time unless medically necessary and will be asked to report any changes made to their treatment plan on a daily basis.

Interventions

Mindfulness Oriented Recovery Enhancement OTHER

Participants randomized to the intervention group will undergo an eight-week mindfulness training program as instructed by MORE for the Treatment of Chronic Pain manual. This eight-week intervention will consist of weekly synchronous video conferencing sessions during which participants will be asked to follow along with a guided meditation read by the study lead and to engage in reflection and discussion exercises with other study participants. Participants will also be asked to complete weekly activities and daily mindfulness practices outside of weekly synchronous meetings.

Also known as: MORE

Intervention (MORE) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Presence of previous diagnosis of LR
• a: 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.
• b: Diagnosis of lumbosacral radiculopathy/radiculitis secondary to low back pain that extends below the knee, with symptoms present for greater than 6 weeks.
• : At least 18 years of age and not older than 64 at the time of study enrollment.
• : Ability to read and understand English.
• : Willingness to be randomized to either an experimental or a control group.
• : Willingness to refrain from unnecessary or self-directed pain management/treatment plan changes during study enrollment and to report necessary changes made.
• : Daily access to the internet via cell phone, tablet, or computer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

National University of Natural Medicine Helfgott Research Institute

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Courtney "Katie" Pickworth, ND, MS

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Wexler, BS

CONTACT

503-552-1836; MOREstudy@nunm.edu

Emily Stack

CONTACT

503-552-1777; estack@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: RAs recruited onto the study team to conduct study visits will not have access to information regarding participant group assignment. Study leads providing the intervention will have the opportunity to run baseline participant visits but will not be allowed to run follow-up study visits for participants in any cohort to which they have delivered an intervention. The Principal Investigator and statistician will be completely blinded to group assignments
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Faculty

Model Details: Control Group = treatment as usual (TAU) Intervention Group = 8-week virtual mindfulness session

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 26, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

US (1)