Clinical trial NCT03986489: Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
Official title: Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Dance/movement therapy
Mindfulness-based dance/movement therapy
Chronic pain management
Creative Arts Therapies
Non-pharmacological intervention
Online intervention
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Stony Brook University
First posted: 2019-06-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, acceptability and credibility of a mindfulness-based dance/movement therapy (M-DMT) protocol that is delivered online; to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of M-DMT; and to demonstrate proof of principle by gathering information about the process of change between M-DMT and a control condition.

This is the first study to address the potential of M-DMT as a creative, non-opioid intervention for chronic back pain. Therefore, the findings of this study will provide important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research, namely a fully powered RCT to evaluate efficacy and treatment mechanisms of action. Data obtained as part of this study will be instrumental for informing the systematic evaluation of M-DMT for chronic back pain care.


Eligibility criteria: Inclusion Criteria

* age \> 18 years
* current non-specific cLBP that has persisted at least 3 months, and has resulted in pain on at least half the day in the past 6 months
* proficient in English
* average pain severity and interference ratings \>3/10 on a 0-10 numeric rating scale
* if taking pain medication(s), dosage must be stabilized for a minimum of 3 months
* patients agree not to seek additional therapies for the duration of this study beyond those already included in their current treatment regimen or new treatments prescribed by their physician
* naïve to DMT.
* those who have adequate computer literacy (e.g., know how to use a computer to perform basic tasks such as open/send emails, use internet, fill-out online surveys) and access to the virtual delivery format (i.e., internet service and a personal computer device such as laptop, desktop, tablet PC).

Exclusion Criteria:

* pregnancy
* severe and/or progressive medical, neurological, substance dependence within the last 6 months or severe mental illness (i.e., psychosis, mania) that would prevent active participation
* cognitive impairment that prohibits informed consent
* back surgery in the last 6 months
* low back pain attributable to a recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome
* wheelchair-bound or unable to move without assistance
* involvement in impending litigation or judgment for disability or worker's compensation.

Primary outcomes:
measure: Feasibility of Recruitment: Number of participants eligible
timeFrame: Baseline
measure: Recruitment Rate
timeFrame: Baseline
measure: Recruitment time
timeFrame: Baseline
measure: Feasibility of recruiting male participants: Proportion of male participant enrolled
timeFrame: Baseline
measure: Treatment Completion Rate
timeFrame: 12 weeks following receipt of treatment
measure: Retention Rate
timeFrame: 24 weeks
measure: Reason for withdrawal
timeFrame: 12 weeks following receipt of treatment
measure: M-DMT intervention credibility and expectancy
timeFrame: 1 week
measure: Treatment Fidelity
timeFrame: 1-12 weeks
measure: Treatment satisfaction and acceptability: Likert-scale survey
timeFrame: 12 weeks post-randomization
measure: M-DMT intervention acceptability
timeFrame: 12 weeks
measure: Adverse Event
timeFrame: 1 -12 weeks
Secondary outcomes:
measure: Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
timeFrame: Change from Baseline pain intensity at 6, 12, and 24-week time points
measure: Pain interference: PROMIS® Pain Interference -8a
timeFrame: Change from Baseline pain interference at 6, 12, and 24-week time points
measure: Chronic pain acceptance: Chronic Pain Acceptance Questionnaire
timeFrame: Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
measure: Mindfulness
timeFrame: Change from Baseline mindfulness at 6, 12, and 24-week time points
measure: Physical activity (Accelerometry data)
timeFrame: Change from Baseline physical activity at 12, and 24-week time points
measure: Physical activity (Self-report data)
timeFrame: Change from Baseline physical activity at 6, 12, and 24-week time points
Other outcomes:
measure: Physical Function
timeFrame: Change from Baseline physical function at 6, 12, and 24-week time points
measure: Depression
timeFrame: Change from Baseline depression at 6, 12, and 24-week time points
measure: Sleep Disturbance
timeFrame: Change from Baseline sleep disturbance at 6, 12, and 24-week time points
measure: Pain Catastrophizing: Pain Catastrophizing Scale
timeFrame: Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
measure: Kinesiophobia
timeFrame: Change from Baseline kinesiophobia at 6, 12, and 24-week time points
measure: Patient Perception of Change
timeFrame: 12 weeks
Locations:
city: Philadelphia
country: United States
facility: Drexel Universitsy
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Minjung Shim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stony Brook University
name: Adam Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References: