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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03986489
• Other study ID #: 1810006694
• Secondary ID: 7R34AT009555-02
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 2022

Study information

• Verified date: December 2020
• Source: Drexel University
• Contact: Minjung Shim, PhD
• Phone: 267-359-5592
• Email: ms344[@]drexel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Drexel Universitsy	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Drexel University	National Center for Complementary and Integrative Health (NCCIH), Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Feasibility of Recruitment: Number of participants eligible	Number of participants eligible for randomization to the study intervention	Baseline
Primary	Recruitment Rate	Proportion of participants randomized relative to total trial referrals	Baseline
Primary	Recruitment time	Number of participate enrolled per month	Baseline
Primary	Feasibility of recruiting male participants: Proportion of male participant enrolled	Proportion of male participant enrolled to the study	Baseline
Primary	Treatment Completion Rate	We expect 80% of participants to complete at least 9/12 M-DMT sessions	12 weeks following receipt of treatment
Primary	Retention Rate	Proportion of participants who complete follow-up questionnaires	24 weeks
Primary	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
Primary	M-DMT intervention credibility and expectancy	Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)	1 week
Primary	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
Primary	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
Primary	M-DMT intervention acceptability	Exit interview based on an interview protocol developed by the researcher	12 weeks
Primary	Adverse Event	Number of adverse events	1 -12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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