Move in Mind: Program for Reducing Musculoskeletal Pain

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.

Study Overview

• Status: Withdrawn
• Conditions: Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Move in Mind Program; Behavioral: 6 Week Waitlist Control

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Move in Mind Program; 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.	Behavioral: Move in Mind Program; 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.
Other: 6 Week Waitlist Control; 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.	Behavioral: 6 Week Waitlist Control; The waitlist control group will receive the Move in Mind program after 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days after last intervention session in week six

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in changes in physical and mental health at the end of treatment/waitlist period.	12-item Short Form Health Survey (SF-12 version)	7 days after last intervention session in week six
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.	7 days after last intervention session in week six
Difference in positive and negative affect at the end of treatment/waitlist period.	The Positive and Negative Affect Schedule (PANAS)	7 days after last intervention session in week six
Difference in depressive disorder diagnoses and depressive symptom severity at the end of treatment/waitlist period.	Patient Health Questionnaire (PHQ-9)	7 days after last intervention session in week six
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).	7 days after last intervention session in week six

Collaborators and Investigators

• Sponsor: McGill University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: Institute of Psychiatry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No