- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04108403
Mechanisms of Massage
September 15, 2022 updated by: University of Florida
The investigators have previously found moderately painful massage produces comparable changes in pain sensitivity as a conditioned pain modulation paradigm in healthy participants suggesting shared underlying mechanisms.
The researchers aim to extend these findings by understanding the influence of expectation on these findings.
Study Overview
Status
Completed
Detailed Description
Massage is a muscle biased intervention individuals seek for pain alleviation; however, the mechanisms of massage are not well established.
In this study, the investigators aim to determine the effect of expectations on massage related hypoalgesia.
Individuals meeting eligibility criteria and agreeing to participate will attend one session that lasts approximately one hour.
A myofascial trigger point (taut band of muscle tissue) will be assessed on the neck of the participant.
Next, a baseline assessment of pressure pain threshold will be performed followed by random assignment to one of four study arms.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- UF Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pain Free
Exclusion Criteria:
- non-English speaking
- systemic medical condition known to affect sensation (i.e. diabetes)
- regular use of prescription pain medication to manage pain
- current or history of chronic pain condition
- currently using blood thinning medication
- any blood clotting disorder such as hemophilia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain Inducing Massage and Positive Expectation Instructions
A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck.
Participants in this arm will receive a positive expectation instructional set followed by a moderately painful massage (pain = 50/100).
Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.
|
A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.
Participants will be instructed that the massage is effective for some people with neck pain.
|
Active Comparator: Pain Inducing Massage and Negative Expectation Instructions
A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck.
Participants in this arm will receive a negative expectation instructional set followed by a moderately painful massage (pain = 50/100).
Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.
|
A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.
Participants will be instructed that the massage is ineffective for some people with neck pain.
|
Active Comparator: Pain Free Massage and Positive Expectation Instructions
A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck.
Participants in this arm will receive a positive expectation instructional set followed by a pain free massage (pain = 0/100).
Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.
|
Participants will be instructed that the massage is effective for some people with neck pain.
A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.
|
Active Comparator: Pain Free Massage and Negative Expectation Instructions
A myofascial trigger point will be assessed in the trapezius muscle and massage applied to this area of the neck.
Participants in this arm will receive a negative expectation instructional set followed by a pain free massage (pain = 0/100).
Massage will be applied for one minute, four times with assessment of pressure pain threshold at the foot between each interval.
|
Participants will be instructed that the massage is ineffective for some people with neck pain.
A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold
Time Frame: 1 hour
|
A computerized pressure algometer with a 1cm diameter rubber tip will be applied to the web space of the non-dominant foot.
Participants are instructed to say "stop" so the stimulus can be terminated when the sensation first transitions from pressure to pain (threshold).
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joel Bialosky, PT, PhD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2019
Primary Completion (Actual)
December 15, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
September 26, 2019
First Submitted That Met QC Criteria
September 26, 2019
First Posted (Actual)
September 30, 2019
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IRB201902417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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