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

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ClinicalTrials.gov Identifier: NCT03986489
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Stony Brook University
Information provided by (Responsible Party):
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; 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.


Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Behavioral: Mindfulness-based dance/movement therapy (M-DMT) Behavioral: Chronic pain social support group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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 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 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 Name: 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) social support group.
Behavioral: Chronic pain social support group

The therapist will facilitate 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 handouts with brief information about the topic discussed during the group session.





Primary Outcome Measures :
  1. Feasibility of Recruitment: Number of participants eligible [ Time Frame: Baseline ]
    Number of participants eligible for randomization to the study intervention

  2. Recruitment Rate [ Time Frame: Baseline ]
    Proportion of participants randomized relative to total trial referrals

  3. Recruitment time [ Time Frame: Baseline ]
    Number of participate enrolled per month

  4. Feasibility of recruiting male participants: Proportion of male participant enrolled [ Time Frame: Baseline ]
    Proportion of male participant enrolled to the study

  5. Treatment Completion Rate [ Time Frame: 12 weeks following receipt of treatment ]
    We expect 80% of participants to complete at least 9/12 M-DMT sessions

  6. Retention Rate [ Time Frame: 24 weeks ]
    Proportion of participants who complete follow-up questionnaires

  7. Reason for withdrawal [ Time Frame: 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

  8. M-DMT intervention credibility and expectancy [ Time Frame: 1 week ]
    Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)

  9. Treatment Fidelity [ Time Frame: 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)

  10. Treatment satisfaction and acceptability: Likert-scale survey [ Time Frame: 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).

  11. M-DMT intervention acceptability [ Time Frame: 12 weeks ]
    Exit interview based on an interview protocol developed by the researcher

  12. Adverse Event [ Time Frame: 1 -12 weeks ]
    Number of adverse events


Secondary Outcome Measures :
  1. Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a [ Time Frame: 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.

  2. Pain interference: PROMIS® Pain Interference -8a [ Time Frame: 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

  3. Chronic pain acceptance: Chronic Pain Acceptance Questionnaire [ Time Frame: 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)

  4. Mindfulness [ Time Frame: 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

  5. Physical activity (Accelerometry data) [ Time Frame: 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)

  6. Physical activity (Self-report data) [ Time Frame: 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)


Other Outcome Measures:
  1. Physical Function [ Time Frame: Change from Baseline physical function at 6, 12, and 24-week time points ]
    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

  2. Depression [ Time Frame: Change from Baseline depression at 6, 12, and 24-week time points ]
    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

  3. Sleep Disturbance [ Time Frame: Change from Baseline sleep disturbance at 6, 12, and 24-week time points ]
    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

  4. Pain Catastrophizing: Pain Catastrophizing Scale [ Time Frame: Change from Baseline pain catastrophizing at 6, 12, and 24-week time points ]
    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

  5. Kinesiophobia [ Time Frame: Change from Baseline kinesiophobia at 6, 12, and 24-week time points ]
    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

  6. Patient Perception of Change [ Time Frame: 12 weeks ]
    Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better))



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986489


Contacts
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Contact: Minjung Shim, PhD 267-359-5592 ms344@drexel.edu
Contact: Adam Gonzalez, PhD 631-632-8675 adam.gonzalez@stonybrookmedicine.edu

Locations
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United States, Pennsylvania
Drexel Universitsy Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Minjung Shim, PhD    267-359-5592    ms344@drexel.edu   
Contact: Bradt, PhD         
Sponsors and Collaborators
Drexel University
National Center for Complementary and Integrative Health (NCCIH)
Stony Brook University
Investigators
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Principal Investigator: Minjung Shim, PhD Drexel University
Principal Investigator: Adam Gonzalez, PhD Stony Brook University

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Responsible Party: Drexel University
ClinicalTrials.gov Identifier: NCT03986489     History of Changes
Other Study ID Numbers: 1810006694
7R34AT009555-02 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Drexel University:
Dance/movement therapy
Mindfulness-based dance/movement therapy
Chronic pain management
Creative Arts Therapies
Non-pharmacological intervention

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms