Musculoskeletal PainNCT04381975
Move in Mind: Program for Reducing Musculoskeletal Pain
A study testing Move in Mind Program in people with Musculoskeletal Pain and Chronic Pain, run by McGill University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Chronic Pain
- What is being tested?
- Move in Mind Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- experiencing a type of mild musculoskeletal pain (e.g., pain related to the muscles, ligaments, bones, joints, or nerve compression)
Who cannot join
- pregnant
- receiving treatment for severe chronic pain
- have had recent concussions or fractures as a result of accidents
About this study
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
- Being tested
- Move in Mind Program, 6 Week Waitlist Control
- Medical subject headings
- Musculoskeletal Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Move in Mind ProgramBehavioural
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 ControlBehavioural
The waitlist control group will receive the Move in Mind program after 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: 6 Week Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
12-item Short Form Health Survey (SF-12 version)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 7 days after last intervention session in week six
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Key collaborator, who would have delivered the intervention, moved abroad
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbel Knauper, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381975
- Sponsor's protocol ID
- 0
- Status last verified
- Mar 2024
- First submitted
- 6 May 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move in Mind: Program for Reducing Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT04381975
- Acronym / sponsor ID
- 0
- Conditions
- Musculoskeletal Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Key collaborator, who would have delivered the intervention, moved abroad
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Move in Mind Program | Experimental | Behavioral: Move in Mind ProgramThe 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. |
| 6 Week Waitlist Control | Other | Behavioral: 6 Week Waitlist ControlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 or older
- experiencing a type of mild musculoskeletal pain (e.g., pain related to the muscles, ligaments, bones, joints, or nerve compression)
Key exclusion criteria (3 listed)
- pregnant
- receiving treatment for severe chronic pain
- have had recent concussions or fractures as a result of accidents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Move in Mind ProgramEach 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. | Behavioural | Move in Mind Program |
| 6 Week Waitlist ControlThe waitlist control group will receive the Move in Mind program after 6 weeks. | Behavioural | 6 Week Waitlist Control |
Primary outcome
Difference in quality and intensity of pain at the end of treatment/waitlist period.
Time frame: 7 days after last intervention session in week six
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).
5 secondary outcomes
Difference in changes in physical and mental health at the end of treatment/waitlist period.
Time frame: 7 days after last intervention session in week six
Difference in perceived stress at the end of treatment/waitlist period.
Time frame: 7 days after last intervention session in week six
Difference in positive and negative affect at the end of treatment/waitlist period.
Time frame: 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.
Time frame: 7 days after last intervention session in week six
Difference in satisfaction with Move in Mind program at the end of treatment/waitlist period.
Time frame: 7 days after last intervention session in week six
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Move in Mind Program in people with Musculoskeletal Pain and Chronic Pain, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in quality and intensity of pain at the end of treatment/waitlist period. (time frame: 7 days after last intervention session in week six). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.