Recruiting

Mindfulness-based Dance/Movement TherapyMindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

Sponsor:

Drexel University

Code:

NCT03986489

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness-based dance/movement therapy (M-DMT)

Chronic pain social support group

Study Details

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.

Conditions

Chronic Low-back Pain

Study ID

NCT03986489

Start date

Apr 1, 2019

Status verified date

Dec, 2020

Completion date

Jul, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness-based dance/movement therapy

Participants assigned to the M-DMT group condition will receive care as usual plus 12 weekly 90-minute group M-DMT sessions delivered online by a board-certified dance/movement therapist. The therapist is instructed to follow the M-DMT manualized protocol.

active comparator: Chronic pain social support group

Participants assigned to the control condition will participate in a 12-session (90-minute session/week) online social support group.

Interventions

Mindfulness-based dance/movement therapy (M-DMT)

M-DMT includes benefits of physical activity, group psychotherapy, mindfulness training, and an art-based intervention in a unified practice. Each online session focuses on different psycho-educational topics about chronic low back pain management and links these topics with specific M-DMT activities that incorporate mindfulness-based principles and techniques.

Chronic pain social support group

The therapist will facilitate online open group discussions about participants' experiences with or reactions to the topic of discussion and will promote empathy among group members. The therapist will use client-centered, reflective listening techniques but will not prescribe any specific recommendations for change.

Each week, SSG participants will receive emails with brief information about the topic discussed during the group session.

Primary outcome measure

Feasibility of Recruitment: Number of participants eligible [ Time Frame: Baseline ]
Recruitment Rate [ Time Frame: Baseline ]
Recruitment time [ Time Frame: Baseline ]
Feasibility of recruiting male participants: Proportion of male participant enrolled [ Time Frame: Baseline ]
Treatment Completion Rate [ Time Frame: 12 weeks following receipt of treatment ]
Retention Rate [ Time Frame: 24 weeks ]
Reason for withdrawal [ Time Frame: 12 weeks following receipt of treatment ]
M-DMT intervention credibility and expectancy [ Time Frame: 1 week ]
Treatment Fidelity [ Time Frame: 1-12 weeks ]
Treatment satisfaction and acceptability: Likert-scale survey [ Time Frame: 12 weeks post-randomization ]
M-DMT intervention acceptability [ Time Frame: 12 weeks ]
Adverse Event [ Time Frame: 1 -12 weeks ]

Central Contacts and Locations

Central contacts

Minjung Shim, PhD

267-359-5592 ms344@drexel.edu

Adam Gonzalez, PhD

631-632-8675 adam.gonzalez@stonybrookmedicine.edu

Locations

Drexel Universitsy

Recruiting

Philadelphia, Pennsylvania, United States, 19102

Contacts

Minjung Shim, PhD

267-359-5592 ms344@drexel.edu

More Information

Sponsor

Drexel University

Last update posted

Apr 15, 2021

Last verified

Dec, 2020

Keywords

Dance/movement therapy
Mindfulness-based dance/movement therapy
Chronic pain management
Creative Arts Therapies
Non-pharmacological intervention
Online intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Drexel University on 2021-04-15.