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出境医 / 临床实验 / Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

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

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.


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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 2021
Estimated Study Completion Date : July 2022
Arms and Interventions
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 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) 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.


Outcome Measures
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))


Eligibility Criteria
Layout table for eligibility information
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.
  • 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.
Contacts and Locations

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

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Minjung Shim, PhD Drexel University
Principal Investigator: Adam Gonzalez, PhD Stony Brook University
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 14, 2019
Last Update Posted Date April 15, 2021
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Feasibility of Recruitment: Number of participants eligible [ Time Frame: Baseline ]
    Number of participants eligible for randomization to the study intervention
  • Recruitment Rate [ Time Frame: Baseline ]
    Proportion of participants randomized relative to total trial referrals
  • Recruitment time [ Time Frame: Baseline ]
    Number of participate enrolled per month
  • Feasibility of recruiting male participants: Proportion of male participant enrolled [ Time Frame: Baseline ]
    Proportion of male participant enrolled to the study
  • 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
  • Retention Rate [ Time Frame: 24 weeks ]
    Proportion of participants who complete follow-up questionnaires
  • 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
  • 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)
  • 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)
  • 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).
  • M-DMT intervention acceptability [ Time Frame: 12 weeks ]
    Exit interview based on an interview protocol developed by the researcher
  • Adverse Event [ Time Frame: 1 -12 weeks ]
    Number of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • 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.
  • 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
  • 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)
  • 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
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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))
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
Official Title  ICMJE Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low-back Pain
Intervention  ICMJE
  • 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 Name: Dance/Movement Therapy
  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness-based dance/movement therapy (M-DMT)
  • 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.
    Intervention: Behavioral: Chronic pain social support group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2021)
64
Original Estimated Enrollment  ICMJE
 (submitted: June 13, 2019)
72
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Minjung Shim, PhD 267-359-5592 ms344@drexel.edu
Contact: Adam Gonzalez, PhD 631-632-8675 adam.gonzalez@stonybrookmedicine.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03986489
Other Study ID Numbers  ICMJE 1810006694
7R34AT009555-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Drexel University
Study Sponsor  ICMJE Drexel University
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • Stony Brook University
Investigators  ICMJE
Principal Investigator: Minjung Shim, PhD Drexel University
Principal Investigator: Adam Gonzalez, PhD Stony Brook University
PRS Account Drexel University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP