Move in Mind: Program for Reducing Musculoskeletal Pain

Chronic Pain Clinical Trial

Official title:

Move in Mind: Program for Reducing Musculoskeletal Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04381975
• Other study ID #: 0
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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.
• 6 Week Waitlist Control
The waitlist control group will receive the Move in Mind program after 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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