Lumbar RadiculopathyMORENCT04818606
MORE in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
A study testing Mindfulness Oriented Recovery Enhancement in people with Lumbar Radiculopathy, run by National University of Natural Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Mindfulness Oriented Recovery Enhancement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National University of Natural Medicine Helfgott Research Institute
Portland, Oregon, 97201
Ryan Wexler, BS, 503-552-1836, MOREstudy@nunm.edu
Courtney "Katie" Pickworth, ND, MS, 503-552-1565, kpickworth@nunm.edu
About this study
Official title: Mindfulness-Oriented Recovery Enhancement in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
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.
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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
- Being tested
- Mindfulness Oriented Recovery Enhancement
- Keywords
- lumbar radiculopathy, Mindfulness Oriented Recovery Enhancement(MORE), mindfulness, integrative and complementary health
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery EnhancementOther
Also called MORE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 8-Week Follow-Up
Secondary outcomes (7)
Change in painDETECT Questionnaire Score
The PD-Q is a self-reporting pain questionnaire that is designed to assess the presence of neuropathic pain in patients with chronic low back pain and lumbosacral radiculopathy/radiculitis. The PD-Q is scored on a scale from -1 to 38 where scores 19 or greater indicate likely presence of neuropathic pain, scores from 12 to 18 represent ambiguous pain, and scores below 12 represent a likelihood that neuropathic pain is not present.
Measured: Change from Baseline to 8-Week Follow-Up
Change in Visual Analog Scale Score
he VAS is a self-reporting scale where participants are asked to report their pain on a scale of 1 to 10 where 0 represents "no pain" and 10 represents "worst pain".
Measured: Change from Intervention Week 1 to Intervention Week 8
Change in SF-12 Patient Questionnaire for Quality of Life Score
The SF-12 QoL assesses an individual's overall quality of life using self-reporting questions to determine an individual's ability to accomplish and complete activities of daily living as well as their overall mood and outlook on life
Measured: Change from Baseline to 8-Week Follow-Up
Change in Major Depression Inventory Score
The MDI is a self-report questionnaire that includes questions about depression symptoms consistent with the DSM V guidelines for major depressive disorder.
Measured: Change from Baseline to 8-Week Follow-Up
Change in Five Facet Mindfulness Questionnaire Score
The FFMQ is a self-reported questionnaire that assesses an individual's trait mindfulness using five "facets" or categories of mindfulness: Observing, Describing, Acting with Awareness, Nonjudging of inner experience, and Nonreactivity to inner experience. Participants respond to 39 questions such as "I can easily put my beliefs, opinions, and expectations into words" on a scale of never or very rarely true (1) to very often or always true (5).
Measured: Change from Baseline to 8-Week Follow-Up
Change in Mindful Reinterpretation of Painful Sensations Scale Score
he MRPS is a 9 item survey that asks participants to respond to questions regarding their perspective of their pain such as "I try to watch my pain from a distance, as if I were an objective observer," on a scale ranging from "never do that" (0) to "always do that" (6).
Measured: Change from Baseline to 8-Week Follow-Up
Change in Surface Electromyography RMS and RMS peak time
articipants will undergo sEMG to evaluate the function of the anterior tibialis and lateral gastrocnemius muscles which have been shown to be dysfunctional in patients with L5 and S1 nerve root compression.6,7,72 Measurement will be taken bilaterally, but analyses will be done to compare the symptomatic and asymptomatic side in patients with only unilateral symptoms.
Measured: Change from Baseline to 8-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Feb 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control Group = treatment as usual (TAU) Intervention Group = 8-week virtual mindfulness session
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Pickworth, National University of Natural Medicine
- Investigators
- Courtney "Katie" Pickworth, ND, MS, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818606
- Sponsor's protocol ID
- KP112720
- Acronym
- MORE
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Oriented Recovery Enhancement in the Management of Lumbosacral Radiculopathy Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04818606
- Acronym / sponsor ID
- MORE / KP112720
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radiculopathy, Mindfulness Oriented Recovery Enhancement(MORE), mindfulness, integrative and complementary health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Control Group = treatment as usual (TAU) Intervention Group = 8-week virtual mindfulness session
| Arm | Type | Receives |
|---|---|---|
| Intervention (MORE) Group | Experimental | Other: Mindfulness Oriented Recovery EnhancementParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Oriented Recovery EnhancementAlso: MOREParticipants 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. | Other | Intervention (MORE) Group |
Primary outcome
Change in Modified Oswestry Low Back Pain Disability Questionnaire Score
Time frame: Change from Baseline to 8-Week Follow-Up
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.
7 secondary outcomes
Change in painDETECT Questionnaire Score
Time frame: Change from Baseline to 8-Week Follow-Up
Change in Visual Analog Scale Score
Time frame: Change from Intervention Week 1 to Intervention Week 8
Change in SF-12 Patient Questionnaire for Quality of Life Score
Time frame: Change from Baseline to 8-Week Follow-Up
Change in Major Depression Inventory Score
Time frame: Change from Baseline to 8-Week Follow-Up
Change in Five Facet Mindfulness Questionnaire Score
Time frame: Change from Baseline to 8-Week Follow-Up
Change in Mindful Reinterpretation of Painful Sensations Scale Score
Time frame: Change from Baseline to 8-Week Follow-Up
Change in Surface Electromyography RMS and RMS peak time
Time frame: Change from Baseline to 8-Week Follow-Up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney "Katie" Pickworth, ND, MS principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Oriented Recovery Enhancement in people with Lumbar Radiculopathy, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ryan Wexler, BS (503-552-1836, MOREstudy@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Oswestry Low Back Pain Disability Questionnaire Score (time frame: Change from Baseline to 8-Week Follow-Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.