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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Mindfulness-based dance/movement therapy (M-DMT); Behavioral: Chronic pain social support group

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minjung Shim, PhD; Phone Number: 267-359-5592; Email: ms344@drexel.edu
• Study Contact Backup: Name: Adam Gonzalez, PhD; Phone Number: 631-632-8675; Email: adam.gonzalez@stonybrookmedicine.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Recruiting
      • Drexel Universitsy
      • Contact: Minjung Shim, PhD; Phone Number: 267-359-5592; Email: ms344@drexel.edu
      • Contact: Bradt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.; Other Names: Dance/Movement Therapy
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Recruitment: Number of participants eligible	Number of participants eligible for randomization to the study intervention	Baseline
Recruitment Rate	Proportion of participants randomized relative to total trial referrals	Baseline
Recruitment time	Number of participate enrolled per month	Baseline
Feasibility of recruiting male participants: Proportion of male participant enrolled	Proportion of male participant enrolled to the study	Baseline
Treatment Completion Rate	We expect 80% of participants to complete at least 9/12 M-DMT sessions	12 weeks following receipt of treatment
Retention Rate	Proportion of participants who complete follow-up questionnaires	24 weeks
Reason for withdrawal	Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview	12 weeks following receipt of treatment
M-DMT intervention credibility and expectancy	Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)	1 week
Treatment Fidelity	Treatment fidelity assessment form developed by the researcher (range: varies between sessions depending on the number of items included in the particular session; A total score of 80% and higher reflects adequate treatment fidelity)	1-12 weeks
Treatment satisfaction and acceptability: Likert-scale survey	via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome).	12 weeks post-randomization
M-DMT intervention acceptability	Exit interview based on an interview protocol developed by the researcher	12 weeks
Adverse Event	Number of adverse events	1 -12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a	PROMIS® Pain Intensity-Short Form (SF)3a (A 5-point (from 1= Had no pain to 5= Very Severe) rating scale is used in each of the 3 items; higher results mean higher intensity of pain.	Change from Baseline pain intensity at 6, 12, and 24-week time points
Pain interference: PROMIS® Pain Interference -8a	PROMIS® Pain Interference -8a (A 5-point (from 1= Not at all to 5= Very much) rating scale is used on each of the 8 items; higher scores reflect greater pain interference	Change from Baseline pain interference at 6, 12, and 24-week time points
Chronic pain acceptance: Chronic Pain Acceptance Questionnaire	Chronic Pain Acceptance Questionnaire (A seven-point (from 0= Never to 6 = Always) rating scale is used in each of the 20 items; higher results mean high pain acceptance)	Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
Mindfulness	Cognitive and Affective Mindfulness Scale (A 4-point (Rarely/not at all to almost always) rating scale is used in each of the 12 items; higher values reflect higher mindful qualities	Change from Baseline mindfulness at 6, 12, and 24-week time points
Physical activity (Accelerometry data)	An accelerometer, ActiGraph GT9X will be used to measure the change in participants physical activity between baseline and 2 endpoints (12 and 24 weeks)	Change from Baseline physical activity at 12, and 24-week time points
Physical activity (Self-report data)	Self-report assessment of physical activity will be done through UCLA Activity Scale (One item out of 10 will be checked to best describe current activity level)	Change from Baseline physical activity at 6, 12, and 24-week time points

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	PROMIS® Physical function-20a (A 5-point (5= without any difficulty to 1= Unable to do) rating scale is used in each of the 20 items; higher values reflect higher abilities to physically function	Change from Baseline physical function at 6, 12, and 24-week time points
Depression	PROMIS® Emotional Distress-Depression-SF 4a (A 5-point (1= Never to 5= Always) rating scale is used in each of the 4 items; higher values reflect higher levels of depression	Change from Baseline depression at 6, 12, and 24-week time points
Sleep Disturbance	PROMIS® Sleep Disturbance-4a (A 5-point (5= Very poor to 1= Very good) rating scale is used in each of the 4 items; higher values reflect higher levels of sleep disturbances	Change from Baseline sleep disturbance at 6, 12, and 24-week time points
Pain Catastrophizing: Pain Catastrophizing Scale	Pain Catastrophizing Scale - short form(SF)-4a (A 4-point (0= Not at all to 4= All the time) rating scale is used in each of the 4 items; higher scores reflect greater pain catastrophizing	Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
Kinesiophobia	Tampa Scale of Kinesiophobia (A 4-point (1= Strongly disagree to 4= Strongly agree) rating scale is used in each of the 11 items; higher values reflect higher levels of kinesiophobia	Change from Baseline kinesiophobia at 6, 12, and 24-week time points
Patient Perception of Change	Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better))	12 weeks

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: Stony Brook University; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Minjung Shim, PhD, Drexel University; Principal Investigator: Adam Gonzalez, PHD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (Actual): June 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Non-pharmacological intervention; Online intervention; Dance/movement therapy; Mindfulness-based dance/movement therapy; Chronic pain management; Creative Arts Therapies
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1810006694; 7R34AT009555-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No