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

Not Applicable

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

• Registration Number: NCT03986489
• Lead Sponsor: Drexel University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Status Verified: 2020-12
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-12
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based dance/movement therapy	Mindfulness-based dance/movement therapy (M-DMT)	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.
Chronic pain social support group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a	Change from Baseline pain intensity at 6, 12, and 24-week time points	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.
Pain interference: PROMIS® Pain Interference -8a	Change from Baseline pain interference at 6, 12, and 24-week time points	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
Chronic pain acceptance: Chronic Pain Acceptance Questionnaire	Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points	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)
Mindfulness	Change from Baseline mindfulness at 6, 12, and 24-week time points	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
Physical activity (Accelerometry data)	Change from Baseline physical activity at 12, and 24-week time points	An accelerometer, ActiGraph GT9X will be used to measure the change in participants physical activity between baseline and 2 endpoints (12 and 24 weeks)
Physical activity (Self-report data)	Change from Baseline physical activity at 6, 12, and 24-week time points	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)

Trial Locations

Locations (1)

Drexel Universitsy; 🇺🇸 Philadelphia, Pennsylvania, United States