Move in Mind: Program for Reducing Musculoskeletal Pain

NCT04381975 | Withdrawn

• 1 other identifier: 0
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Musculoskeletal Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in changes in physical and mental health at the end of treatment/waitlist period.

  7 days after last intervention session in week six

• Difference in perceived stress at the end of treatment/waitlist period.

  7 days after last intervention session in week six

• Difference in positive and negative affect at the end of treatment/waitlist period.

  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.

  7 days after last intervention session in week six

• Difference in satisfaction with Move in Mind program at the end of treatment/waitlist period.

  7 days after last intervention session in week six

Study Arms (2)

Move in Mind Program

EXPERIMENTAL

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

6 Week Waitlist Control

OTHER

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

Interventions

Move in Mind Program BEHAVIORAL

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.

Move in Mind Program

6 Week Waitlist Control BEHAVIORAL

The waitlist control group will receive the Move in Mind program after 6 weeks.

6 Week Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James McGill Professor of Psychology

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03