Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain

Официальное название

Identifying Brain Mechanisms Related to Body Awareness Using QiGong to Relieve Chronic Low Back Pain

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Qigong Exercise
  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.
• Поведенческое P.Volve Exercises
  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, wh

Первичные конечные точки

• Change in Pain Numeric Rating Scale (NRS) [Срок оценки: baseline, 15 weeks]
• Change in Revised Body Awareness Rating Questionnaire (BARQ) [Срок оценки: baseline, 15 weeks]
• Change in Mindfulness Attention Awareness Scale (MAAS) [Срок оценки: baseline, 15 weeks]
• Change in Five-Facet Mindfulness Questionnaire (FFMQ) [Срок оценки: baseline, 15 weeks]
• Change in Proprioception [Срок оценки: baseline, 15 weeks]
• Change in Postural Awareness Scale (PAS) [Срок оценки: baseline, 15 weeks]

Вторичные конечные точки (8)

• Change in Modified Roland Morris Disability Questionnaire [Срок оценки: baseline, 15 weeks]
• Change in Fear-Avoidance Beliefs Questionnaire (FABQ) [Срок оценки: baseline, 15 weeks]
• Change in Pain Self-Efficacy questionnaire (PSEQ) [Срок оценки: baseline, 15 weeks]
• Change in Tampa Scale for Kinesiophobia [Срок оценки: baseline, 15 weeks]
• Change in Core Muscle Stabilization - Prone [Срок оценки: baseline, 15 weeks]
• Change in Core Muscle Stabilization - Supine [Срок оценки: baseline, 15 weeks]
• Change in Balance Test - Right Leg [Срок оценки: baseline, 15 weeks]
• Change in Balance Test - Left Leg [Срок оценки: baseline, 15 weeks]

Критерии участия

Критерии включения

\- Adults with chronic low back pain

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Children's Rehabilitation Center, 426 Church Street SE Room 302 - Brain Body Mind Lab Minn — Minneapolis

Публикации

• Van de Winckel A, Zhang L, Hendrickson T, Lim KO, Mueller BA, Philippus A, Monden KR, Oh J, Huang Q, Sertic JVL, Ruen J, Konczak J, Evans R, Bronfort G. Identifying body awareness-related brain network changes after Spring Forest Qigong practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial. medRxiv [Preprint]. 2023 Mar 1:20 PMID 36824785

Идентификаторы

NCT: NCT04164225 · PMR-2019-27351

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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