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NCT04108403 Clinical Trial

Mechanisms of Massage

Healthy Clinical Trial

Official title:
Mechanisms of Massage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04108403
Other study ID # IRB201902417
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2019
Est. completion date December 15, 2021

Study information
Verified date September 2022
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Pain Inducing Massage
A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.
• Pain Free Massage
A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.
• Positive Expectation Instructional Set
Participants will be instructed that the massage is effective for some people with neck pain.
• Negative Expectation Instructional Set
Participants will be instructed that the massage is ineffective for some people with neck pain.

Locations
Country Name City State
United States UF Health Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pressure Pain Threshold 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
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