search
Back to results

Move in Mind: Program for Reducing Musculoskeletal Pain

Primary Purpose

Musculoskeletal Pain, Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Move in Mind Program
6 Week Waitlist Control
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

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

Inclusion Criteria:

  • 18 or older
  • experiencing a type of mild musculoskeletal pain (e.g., pain related to the muscles, ligaments, bones, joints, or nerve compression)

Exclusion Criteria:

  • pregnant
  • receiving treatment for severe chronic pain
  • have had recent concussions or fractures as a result of accidents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Move in Mind Program

    6 Week Waitlist Control

    Arm Description

    The Move in Mind Program is a 6-week Rolfing®-based intervention program shortened from ten to six sessions and adapted to a group setting by Rolfing® instructor Monica Canducci.

    Participants will be crossed over to the Move in Mind program following the 6-week waitlist control. Participants of the waitlist control group will be asked to complete follow-up questionnaires both at the same time as the intervention group (after week six) as well as after their own program.

    Outcomes

    Primary Outcome Measures

    Difference in quality and intensity of pain at the end of treatment/waitlist period.
    The short-form McGill Pain Questionaire (SF-MPQ) is a 15-item self-report measure that assesses the quality and intensity of a patient's pain. Descriptors either represent the sensory dimension (items 1-11; e.g., "Stabbing") or the affective dimension of pain experience (items 12-15; e.g., "Punishing-Cruel"). Patients respond to the SF-MPQ using an intensity scale ranging from 0 (none) to 3 (severe).

    Secondary Outcome Measures

    Difference in changes in physical and mental health at the end of treatment/waitlist period.
    12-item Short Form Health Survey (SF-12 version)
    Difference in perceived stress at the end of treatment/waitlist period.
    The Perceived Stress Scale is a 10-item scale measuring the degree to which situations in the past month are perceived as overwhelming or unpredictable.
    Difference in positive and negative affect at the end of treatment/waitlist period.
    The Positive and Negative Affect Schedule (PANAS)
    Difference in depressive disorder diagnoses and depressive symptom severity at the end of treatment/waitlist period.
    Patient Health Questionnaire (PHQ-9)
    Difference in satisfaction with Move in Mind program at the end of treatment/waitlist period.
    8 items based on Frayn et al. (2020). Items such as "The program was easy to follow" or "I can see myself using what I learned in the program in the long term" are rated on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).

    Full Information

    First Posted
    May 6, 2020
    Last Updated
    May 8, 2020
    Sponsor
    McGill University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04381975
    Brief Title
    Move in Mind: Program for Reducing Musculoskeletal Pain
    Official Title
    Move in Mind: Program for Reducing Musculoskeletal Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    August 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McGill University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present pilot study will explore the range of mental and physical health benefits associated with a Rolfing®-based intervention program ("Move in Mind"). To assess the effects of this program on pain management and various psychological outcomes, the investigator's study will be offered to individuals with mild chronic musculoskeletal pain (e.g., lower back pain, neck pain, shoulder pain, knee pain, arthritic pain). Shortened from ten to six sessions and adapted to a group setting by Rolfing® instructor Monica Canducci, the intervention will be delivered weekly by Ms. Canducci, who is certified in Rolfing®. The program will target the potential associations of the Move in Mind program with better pain management (primary outcome) as well as increased body awareness and presence, increased well-being, and better stress management (secondary outcomes). Interested participants will be asked to complete a battery of questionnaires and psychometric scales to assess the variables of interest before (baseline) and after their participation in the Move in Mind program (six-week follow-up). A waitlist control group will also be assessed at baseline and follow-up and will then receive the Move in Mind sessions subsequently and also assessed after their participation.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Move in Mind Program
    Arm Type
    Experimental
    Arm Description
    The Move in Mind Program is a 6-week Rolfing®-based intervention program shortened from ten to six sessions and adapted to a group setting by Rolfing® instructor Monica Canducci.
    Arm Title
    6 Week Waitlist Control
    Arm Type
    Other
    Arm Description
    Participants will be crossed over to the Move in Mind program following the 6-week waitlist control. Participants of the waitlist control group will be asked to complete follow-up questionnaires both at the same time as the intervention group (after week six) as well as after their own program.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Move in Mind Program
    Intervention Description
    Each of the six Move in Mind sessions will take place once a week for approximately 1.5 hours, with 12-17 individuals participating per class. The material and exercises taught will include physical floor exercises, breathing exercises, as well as awareness training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    6 Week Waitlist Control
    Intervention Description
    The waitlist control group will receive the Move in Mind program after 6 weeks.
    Primary Outcome Measure Information:
    Title
    Difference in quality and intensity of pain at the end of treatment/waitlist period.
    Description
    The short-form McGill Pain Questionaire (SF-MPQ) is a 15-item self-report measure that assesses the quality and intensity of a patient's pain. Descriptors either represent the sensory dimension (items 1-11; e.g., "Stabbing") or the affective dimension of pain experience (items 12-15; e.g., "Punishing-Cruel"). Patients respond to the SF-MPQ using an intensity scale ranging from 0 (none) to 3 (severe).
    Time Frame
    7 days after last intervention session in week six
    Secondary Outcome Measure Information:
    Title
    Difference in changes in physical and mental health at the end of treatment/waitlist period.
    Description
    12-item Short Form Health Survey (SF-12 version)
    Time Frame
    7 days after last intervention session in week six
    Title
    Difference in perceived stress at the end of treatment/waitlist period.
    Description
    The Perceived Stress Scale is a 10-item scale measuring the degree to which situations in the past month are perceived as overwhelming or unpredictable.
    Time Frame
    7 days after last intervention session in week six
    Title
    Difference in positive and negative affect at the end of treatment/waitlist period.
    Description
    The Positive and Negative Affect Schedule (PANAS)
    Time Frame
    7 days after last intervention session in week six
    Title
    Difference in depressive disorder diagnoses and depressive symptom severity at the end of treatment/waitlist period.
    Description
    Patient Health Questionnaire (PHQ-9)
    Time Frame
    7 days after last intervention session in week six
    Title
    Difference in satisfaction with Move in Mind program at the end of treatment/waitlist period.
    Description
    8 items based on Frayn et al. (2020). Items such as "The program was easy to follow" or "I can see myself using what I learned in the program in the long term" are rated on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).
    Time Frame
    7 days after last intervention session in week six

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 or older experiencing a type of mild musculoskeletal pain (e.g., pain related to the muscles, ligaments, bones, joints, or nerve compression) Exclusion Criteria: pregnant receiving treatment for severe chronic pain have had recent concussions or fractures as a result of accidents

    12. IPD Sharing Statement

    Learn more about this trial

    Move in Mind: Program for Reducing Musculoskeletal Pain

    We'll reach out to this number within 24 hrs