Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT07125027
Status:
RECRUITING
Last Update Posted:
2025-11-12
First Post:
2025-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Sponsor:
National University of Natural Medicine
Organization:
Study Overview
Official Title:
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Move-MORE
Brief Summary:
The Move-MORE study is designed to evaluate a multicomponent mindfulness and movement program for patients with lumbosacral radiculopathy. The program brings together mindfulness training to help participants develop awareness of their body and manage pain-related stress, gentle movement practice to improve comfort with physical activity and support function, and motivational interviewing to strengthen motivation, confidence, and the ability to make healthy changes.
The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.
The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
The main objectives are to determine whether it is feasible for participants to use each component of the program when delivered online, to assess how acceptable and engaging each component is, and to evaluate the impact on pain, physical function, and daily activity levels. The study intervention will be conducted entirely remotely. Participants will complete online surveys, brief daily check-ins on their phone, and wear a small activity monitor on the hip to measure movement. They will also undergo quantitative sensory testing to evaluate pain sensitivity. At the end of the program, participants will share feedback about their experiences via qualitative interviews.
The findings will help identify which parts of the program provide the greatest benefit, with the ultimate goal of developing a more targeted and effective digital program for people with this condition.
Detailed Description:
Lumbosacral radiculopathy (LR) is a spinal pathology that manifests as pain, weakness, and numbness in the lower extremity. Commonly referred to as "sciatica", LR has a lifetime prevalence up to 43%, and can often become an intractable condition with long-term outcomes unimproved by conventional biomedical treatments such as surgery. Thus, we seek to develop a non-invasive and non-pharmacologic treatment for LR patients
This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain.
The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment.
During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention.
This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.
This study aims to 1) develop a multicomponent intervention that integrates Mindfulness-Oriented Recovery Enhancement and physical activity for patients with LR, 2) assess the feasibility and acceptability of this multicomponent intervention, and 3) evaluate preliminary efficacy of the intervention via self-report measures of pain, disability, kinesiophobia, and other psychosocial factors related to chronic pain. In addition, this study will use quantitative sensory testing (i.e., pressure and heat pain thresholds) as an objective measure of pain.
The multicomponent intervention will be developed (AIM 1) using qualitative data from focus groups of LR patients and semi-structured interviews from a multidisciplinary sample of physicians who treat LR. This data will be analyzed using a thematic approach to assess barriers and facilitators to participation, patients' perspectives on non-pharmacologic interventions, and physicians' views of medically necessary considerations. Qualitative findings will be presented to a team of expert mindfulness instructors to support program design. In a single arm trial designed to assess feasibility, acceptability, and preliminary efficacy of the intervention (AIMS 2 and 3), we will administer the multicomponent program developed in Aim 1. Data will be collected from participants at three time points: baseline, midpoint, post-intervention, 3-month follow-up. In addition, ratings of pain intensity will be captured daily via ecologic momentary assessment.
During the intervention period, participants will be asked to attend virtual classes once a week. Between weekly sessions, participants will also be asked to track their home practice, daily levels of pain, and any adverse events via a daily survey. At the end of the study, participants will be asked to participate in a semi-structured exit interview which will inquire about their experience in the intervention.
This study seeks to shift the current research paradigm by being the first to develop and test a novel non-invasive, non-pharmacologic, multicomponent intervention for LR. As such, the proposed research contributes much needed scientific knowledge toward identifying efficacious treatments for a highly prevalent, costly, and intractable condition.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K12NS130673 | NIH | None | https://reporter.nih.gov/quic… | View |