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

Primary Purpose

Chronic Low-back Pain

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Chronic pain social support group

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Dance/movement therapy, Mindfulness-based dance/movement therapy, Chronic pain management, Creative Arts Therapies, Non-pharmacological intervention, Online intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Drexel UniversitsyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based dance/movement therapy

Chronic pain social support group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Feasibility of Recruitment: Number of participants eligible

Number of participants eligible for randomization to the study intervention

Recruitment Rate

Proportion of participants randomized relative to total trial referrals

Recruitment time

Number of participate enrolled per month

Feasibility of recruiting male participants: Proportion of male participant enrolled

Proportion of male participant enrolled to the study

Treatment Completion Rate

We expect 80% of participants to complete at least 9/12 M-DMT sessions

Retention Rate

Proportion of participants who complete follow-up questionnaires

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

M-DMT intervention credibility and expectancy

Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)

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)

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).

M-DMT intervention acceptability

Exit interview based on an interview protocol developed by the researcher

Adverse Event

Number of adverse events

Secondary Outcome Measures

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.

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

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)

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

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)

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)

Full Information

NCT ID

NCT03986489

First Posted

May 29, 2019

Last Updated

April 13, 2021

Sponsor

Drexel University

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Stony Brook University

1. Study Identification

Unique Protocol Identification Number

NCT03986489

Brief Title

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

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Drexel University

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Stony Brook University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low-back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-based dance/movement therapy

Arm Type

Experimental

Arm Description

Arm Title

Chronic pain social support group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

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

Other Intervention Name(s)

Dance/Movement Therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Chronic pain social support group

Intervention Description

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 Information:

Title

Feasibility of Recruitment: Number of participants eligible

Description

Number of participants eligible for randomization to the study intervention

Time Frame

Baseline

Title

Recruitment Rate

Description

Proportion of participants randomized relative to total trial referrals

Time Frame

Baseline

Title

Recruitment time

Description

Number of participate enrolled per month

Time Frame

Baseline

Title

Feasibility of recruiting male participants: Proportion of male participant enrolled

Description

Proportion of male participant enrolled to the study

Time Frame

Baseline

Title

Treatment Completion Rate

Description

We expect 80% of participants to complete at least 9/12 M-DMT sessions

Time Frame

12 weeks following receipt of treatment

Title

Retention Rate

Description

Proportion of participants who complete follow-up questionnaires

Time Frame

24 weeks

Title

Reason for withdrawal

Description

Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview

Time Frame

12 weeks following receipt of treatment

Title

M-DMT intervention credibility and expectancy

Description

Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)

Time Frame

1 week

Title

Treatment Fidelity

Description

Time Frame

1-12 weeks

Title

Treatment satisfaction and acceptability: Likert-scale survey

Description

via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome).

Time Frame

12 weeks post-randomization

Title

M-DMT intervention acceptability

Description

Exit interview based on an interview protocol developed by the researcher

Time Frame

12 weeks

Title

Adverse Event

Description

Number of adverse events

Time Frame

1 -12 weeks

Secondary Outcome Measure Information:

Title

Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a

Description

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.

Time Frame

Change from Baseline pain intensity at 6, 12, and 24-week time points

Title

Pain interference: PROMIS® Pain Interference -8a

Description

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

Time Frame

Change from Baseline pain interference at 6, 12, and 24-week time points

Title

Chronic pain acceptance: Chronic Pain Acceptance Questionnaire

Description

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)

Time Frame

Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points

Title

Mindfulness

Description

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

Time Frame

Change from Baseline mindfulness at 6, 12, and 24-week time points

Title

Physical activity (Accelerometry data)

Description

An accelerometer, ActiGraph GT9X will be used to measure the change in participants physical activity between baseline and 2 endpoints (12 and 24 weeks)

Time Frame

Change from Baseline physical activity at 12, and 24-week time points

Title

Physical activity (Self-report data)

Description

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)

Time Frame

Change from Baseline physical activity at 6, 12, and 24-week time points

Other Pre-specified Outcome Measures:

Title

Physical Function

Description

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

Time Frame

Change from Baseline physical function at 6, 12, and 24-week time points

Title

Depression

Description

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

Time Frame

Change from Baseline depression at 6, 12, and 24-week time points

Title

Sleep Disturbance

Description

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

Time Frame

Change from Baseline sleep disturbance at 6, 12, and 24-week time points

Title

Pain Catastrophizing: Pain Catastrophizing Scale

Description

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

Time Frame

Change from Baseline pain catastrophizing at 6, 12, and 24-week time points

Title

Kinesiophobia

Description

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

Time Frame

Change from Baseline kinesiophobia at 6, 12, and 24-week time points

Title

Patient Perception of Change

Description

Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better))

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Minjung Shim, PhD

Phone

267-359-5592

ms344@drexel.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Adam Gonzalez, PhD

Phone

631-632-8675

adam.gonzalez@stonybrookmedicine.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minjung Shim, PhD

Organizational Affiliation

Drexel University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adam Gonzalez, PhD

Organizational Affiliation

Stony Brook University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Drexel Universitsy

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Minjung Shim, PhD

Phone

267-359-5592

ms344@drexel.edu

First Name & Middle Initial & Last Name & Degree

Bradt, PhD

12. IPD Sharing Statement

Plan to Share IPD

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

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