Clinical trial NCT04164225: 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
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Change in Pain Numeric Rating Scale (NRS)
timeFrame: baseline, 15 weeks
measure: Change in Revised Body Awareness Rating Questionnaire (BARQ)
timeFrame: baseline, 15 weeks
measure: Change in Mindfulness Attention Awareness Scale (MAAS)
timeFrame: baseline, 15 weeks
measure: Change in Five-Facet Mindfulness Questionnaire (FFMQ)
timeFrame: baseline, 15 weeks
measure: Change in Proprioception
timeFrame: baseline, 15 weeks
measure: Change in Postural Awareness Scale (PAS)
timeFrame: baseline, 15 weeks
Secondary outcomes:
measure: Change in Modified Roland Morris Disability Questionnaire
timeFrame: baseline, 15 weeks
measure: Change in Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: baseline, 15 weeks
measure: Change in Pain Self-Efficacy questionnaire (PSEQ)
timeFrame: baseline, 15 weeks
measure: Change in Tampa Scale for Kinesiophobia
timeFrame: baseline, 15 weeks
measure: Change in Core Muscle Stabilization - Prone
timeFrame: baseline, 15 weeks
measure: Change in Core Muscle Stabilization - Supine
timeFrame: baseline, 15 weeks
measure: Change in Balance Test - Right Leg
timeFrame: baseline, 15 weeks
measure: Change in Balance Test - Left Leg
timeFrame: baseline, 15 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minneapolis, MN 55455
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ann Van de Winckel, PhD,MSPT,PT
role: PRINCIPAL_INVESTIGATOR
References: