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
About this trial
This is an interventional treatment trial for Musculoskeletal Pain
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
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
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
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