Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qigong Exercise
P.Volve Exercises
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Adults with chronic low back pain
Exclusion Criteria:
- Those with cognitive problems
- Those unable to speak or understand instructions
- Those who have nerve problems, fractures, or infections
- Those who do not speak English
- Those with severe deficit in motor imagery or in vision (both are used in MRI tasks)
Sites / Locations
- Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minneapolis, MN 55455Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Qigong
P.Volve
Arm Description
Qigong exercises, focused on a mind-body connection
P.Volve exercises, focused on just physical movement
Outcomes
Primary Outcome Measures
Change in Pain Numeric Rating Scale (NRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Pain is rated on a scale of 0-10, with higher scores indicating greater pain intensity.
Change in Revised Body Awareness Rating Questionnaire (BARQ)
The Body Awareness Rating Questionnaire (BARQ) is a self-report questionnaire designed to capture how individuals with long-lasting musculoskeletal pain reflect on their own body awareness. This questionnaire contains 12 items rated on a scale from 0 (completely disagree) to 3 (completely agree). The total score is a sum of all items. Lower scores indicate greater body awareness.
Change in Mindfulness Attention Awareness Scale (MAAS)
The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness. Items are rated on a scale from 1 (almost always) to 6 (almost never). The total score is an unweighted mean of the 15 item scores.
Change in Five-Facet Mindfulness Questionnaire (FFMQ)
The FFMQ is a 39-item scale measuring five facets of mindfulness: observing (items 1, 6, 11, 15, 20, 26, 31, and 36), describing (items 2, 7, 12R, 16R, 22R, 27, 32, and 37), acting with awareness (items 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R), non-judging of inner experience (items 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R), and non-reactivity to inner experience (items 4, 9, 19, 21, 24, 33). Items are rated on a scale from 1 (never or very rarely true) to 5 (very often or always true). Items marked with "R" are scored in reverse. Sub scale and total scale scores can be calculated by sum or unweighted mean. Higher scores indicate higher levels of mindfulness.
Change in Proprioception
Lower-limb proprioception will be measured by a lower limb device that produces assessment of proprioceptive acuity and sensitivity of the ankle and/or knee joint in the sagittal plane. Output is measured in degrees of joint motion of the ankle and knee.
Change in Postural Awareness Scale (PAS)
The PAS is a 12-item scale, which was developed in order to measure self-reported awareness of body posture in patients with chronic pain and to evaluate potential changes in postural awareness induced by a multimodal mind-body training program. Item responses range from 1 (not at all true about me) to 7 (very true about me). Six items are reversely scored, so that higher score values consistently indicate higher postural awareness. Total scores are a sum of items scores and range from 13 to 91, with higher scores indicating greater postural awareness
Secondary Outcome Measures
Change in Modified Roland Morris Disability Questionnaire
The Modified Roland Morris Disability Questionnaire, designed to assess self-rated physical disability caused by low back pain, contains 23 items. Items are scored 0 (no) or 1 (yes). Total scores are calculated as a sum with higher scores indicated greater physical disability caused by low back pain.
Change in Fear-Avoidance Beliefs Questionnaire (FABQ)
The Fear-Avoidance Beliefs Questionnaire (FABQ), a patient-reported questionnaire focusing on how a patient's fear of physical activity and work may affect their low back pain and disability, contains 16 items rated on a 7-point Likert from 0 (completely disagree) to 6 (completely agree). Total scores are calculated as a sum with a maximum score of 96. Higher scores indicated more strongly-hold fear avoidance beliefs.
Change in Pain Self-Efficacy questionnaire (PSEQ)
The Pain Self-Efficacy questionnaire (PSEQ) is a 10-item questionnaire measuring a patient's confidence in their ability to complete a task despite pain. Items are rated on a scale from 0 (not at all confident) to 6 (completely confident). Total scores are a sum of the 10 items scores with a maximum score of 60. Lower scores indicate greater pain-related disability.
Change in Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a 17-item questionnaire measuring fear related to exercise and movement. Items are rated on a scale of 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing the individual item scores after inversion of the individual scores for items 4, 8, 12 and 16. Higher scores indicated greater kinesiophobia.
Change in Core Muscle Stabilization - Prone
Participants are asked to perform a prone bridge position. The length of time the position is held is recorded in seconds.
Change in Core Muscle Stabilization - Supine
Participants are asked to perform a supine bridge position. The length of time the position is held is recorded in seconds.
Change in Balance Test - Right Leg
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Change in Balance Test - Left Leg
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Full Information
NCT ID
NCT04164225
First Posted
April 24, 2019
Last Updated
October 16, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04164225
Brief Title
Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain
Official Title
Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The long-term objective of this investigation is to identify how Qigong affects brain function in brain areas relevant to patients with chronic low back pain (cLBP), thereby setting a foundation from which to perform further clinical research.
Detailed Description
The central hypothesis of this investigation is that, in adults with cLBP, practicing Qigong compared to exercise will result in reduced pain and improved body awareness and proprioception (primary behavioral endpoints), disability, balance, core muscle strength, and other CLBP symptoms will be secondary behavioral endpoints.To test this hypothesis, the investigators will assess (1) participant recruitment and retention ; (2) adherence to interventions, engagement/satisfaction with the program; and (3) changes in body awareness-related brain activation and connectivity pre-post intervention (Qigong vs exercise) related to primary endpoints of pain perception, body awareness and objective measures of lower limb proprioception.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Qigong
Arm Type
Experimental
Arm Description
Qigong exercises, focused on a mind-body connection
Arm Title
P.Volve
Arm Type
Active Comparator
Arm Description
P.Volve exercises, focused on just physical movement
Intervention Type
Behavioral
Intervention Name(s)
Qigong Exercise
Intervention Description
Participants with chronic low back pain will follow the free "5 elements Qigong healing class" (estimate of 6 hours) at the Spring Forest Qigong center and then practice the "5 elements healing Qigong" at home 3 times a week for 40 minutes with a freely available online video, for 12 weeks. A weekly group session (1 hour) will be conducted at the Brain Body Mind Lab with the principal investigator to address questions and demonstrate movements if needed.
Intervention Type
Behavioral
Intervention Name(s)
P.Volve Exercises
Intervention Description
P.Volve exercise focuses on low impact core strengthening, core stabilization, and stretching. The program is similar in delivery as Qigong (i.e., online videos). An introductory class (estimate of 2.5h) will be given by the P.Volve team, the principal investigator, and a physical therapist who has experience with P.Volve exercises. Participants will access online videos for individual home practice in 40min/session, 3x/week for 12 weeks. Participants will receive a P.ball for some exercises, while other exercises are done with no equipment. Tailored videos will be available for those with cLBP. A weekly group session (1 hour) will be conducted at the Brain Body Mind Lab with the principal investigator to address questions and demonstrate movements if needed.
Primary Outcome Measure Information:
Title
Change in Pain Numeric Rating Scale (NRS)
Description
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. Pain is rated on a scale of 0-10, with higher scores indicating greater pain intensity.
Time Frame
baseline, 15 weeks
Title
Change in Revised Body Awareness Rating Questionnaire (BARQ)
Description
The Body Awareness Rating Questionnaire (BARQ) is a self-report questionnaire designed to capture how individuals with long-lasting musculoskeletal pain reflect on their own body awareness. This questionnaire contains 12 items rated on a scale from 0 (completely disagree) to 3 (completely agree). The total score is a sum of all items. Lower scores indicate greater body awareness.
Time Frame
baseline, 15 weeks
Title
Change in Mindfulness Attention Awareness Scale (MAAS)
Description
The MAAS is a 15-item scale designed to assess a core characteristic of mindfulness. Items are rated on a scale from 1 (almost always) to 6 (almost never). The total score is an unweighted mean of the 15 item scores.
Time Frame
baseline, 15 weeks
Title
Change in Five-Facet Mindfulness Questionnaire (FFMQ)
Description
The FFMQ is a 39-item scale measuring five facets of mindfulness: observing (items 1, 6, 11, 15, 20, 26, 31, and 36), describing (items 2, 7, 12R, 16R, 22R, 27, 32, and 37), acting with awareness (items 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R), non-judging of inner experience (items 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R), and non-reactivity to inner experience (items 4, 9, 19, 21, 24, 33). Items are rated on a scale from 1 (never or very rarely true) to 5 (very often or always true). Items marked with "R" are scored in reverse. Sub scale and total scale scores can be calculated by sum or unweighted mean. Higher scores indicate higher levels of mindfulness.
Time Frame
baseline, 15 weeks
Title
Change in Proprioception
Description
Lower-limb proprioception will be measured by a lower limb device that produces assessment of proprioceptive acuity and sensitivity of the ankle and/or knee joint in the sagittal plane. Output is measured in degrees of joint motion of the ankle and knee.
Time Frame
baseline, 15 weeks
Title
Change in Postural Awareness Scale (PAS)
Description
The PAS is a 12-item scale, which was developed in order to measure self-reported awareness of body posture in patients with chronic pain and to evaluate potential changes in postural awareness induced by a multimodal mind-body training program. Item responses range from 1 (not at all true about me) to 7 (very true about me). Six items are reversely scored, so that higher score values consistently indicate higher postural awareness. Total scores are a sum of items scores and range from 13 to 91, with higher scores indicating greater postural awareness
Time Frame
baseline, 15 weeks
Secondary Outcome Measure Information:
Title
Change in Modified Roland Morris Disability Questionnaire
Description
The Modified Roland Morris Disability Questionnaire, designed to assess self-rated physical disability caused by low back pain, contains 23 items. Items are scored 0 (no) or 1 (yes). Total scores are calculated as a sum with higher scores indicated greater physical disability caused by low back pain.
Time Frame
baseline, 15 weeks
Title
Change in Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
The Fear-Avoidance Beliefs Questionnaire (FABQ), a patient-reported questionnaire focusing on how a patient's fear of physical activity and work may affect their low back pain and disability, contains 16 items rated on a 7-point Likert from 0 (completely disagree) to 6 (completely agree). Total scores are calculated as a sum with a maximum score of 96. Higher scores indicated more strongly-hold fear avoidance beliefs.
Time Frame
baseline, 15 weeks
Title
Change in Pain Self-Efficacy questionnaire (PSEQ)
Description
The Pain Self-Efficacy questionnaire (PSEQ) is a 10-item questionnaire measuring a patient's confidence in their ability to complete a task despite pain. Items are rated on a scale from 0 (not at all confident) to 6 (completely confident). Total scores are a sum of the 10 items scores with a maximum score of 60. Lower scores indicate greater pain-related disability.
Time Frame
baseline, 15 weeks
Title
Change in Tampa Scale for Kinesiophobia
Description
The Tampa Scale for Kinesiophobia is a 17-item questionnaire measuring fear related to exercise and movement. Items are rated on a scale of 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing the individual item scores after inversion of the individual scores for items 4, 8, 12 and 16. Higher scores indicated greater kinesiophobia.
Time Frame
baseline, 15 weeks
Title
Change in Core Muscle Stabilization - Prone
Description
Participants are asked to perform a prone bridge position. The length of time the position is held is recorded in seconds.
Time Frame
baseline, 15 weeks
Title
Change in Core Muscle Stabilization - Supine
Description
Participants are asked to perform a supine bridge position. The length of time the position is held is recorded in seconds.
Time Frame
baseline, 15 weeks
Title
Change in Balance Test - Right Leg
Description
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Time Frame
baseline, 15 weeks
Title
Change in Balance Test - Left Leg
Description
Participants are asked to stand on one leg. The length of time the position is held is recorded in seconds.
Time Frame
baseline, 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Adults with chronic low back pain
Exclusion Criteria:
Those with cognitive problems
Those unable to speak or understand instructions
Those who have nerve problems, fractures, or infections
Those who do not speak English
Those with severe deficit in motor imagery or in vision (both are used in MRI tasks)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Van de Winckel, PhD, MSPT, PT
Phone
612-625-1191
Email
avdwlab@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD,MSPT,PT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minneapolis, MN 55455
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann Van de Winckel, PhD, MS, PT
Phone
612-625-1191
Email
avandewi@umn.edu
12. IPD Sharing Statement
Links:
URL
https://www.med.umn.edu/rehabmedicine/research/identifying-qigong-brain-changes
Description
Evaluating the effect and mechanism of Qigong in people with chronic low back pain
Learn more about this trial
Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain
We'll reach out to this number within 24 hrs