- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317702
The Duration of Effects of Massage in Healthy Participants
July 12, 2022 updated by: Abigail Wilson, University of Central Florida
Massage is a common rehabilitation treatment for musculoskeletal pain.
Prior studies indicate massage applied with a deep pressure that induces a moderate amount of pain produces a lessening of pain sensitivity compared to light touch, pain free massage.
The investigators now aim to investigate how long pain sensitivity changes last after 4 minutes of moderately painful massage and determine factors that help predict who displays a lessening of pain sensitivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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
-
Orlando, Florida, United States, 32765
- University of Central Florida
-
-
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. uncontrolled diabetes)
- Regular use of prescription pain medication
- Current or history of chronic pain condition
- Currently taking a blood-thinning medication
- Any blood clotting disorder, such as hemophilia
- Contraindications to the application of a blood pressure cuff to the arm, such as: lymphedema or arterial/venous lines
- Contraindications to elevating the arm above the head or exercising the arm with a light weight, such as a recent surgery or fracture
- Investigator is unable to locate myofascial trigger point in the upper trapezius during testing session
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Moderately Painful Massage
Participants will be seated in a chair with his or her shirt on.
Participants will receive 60 seconds of manual pressure applied to the myofascial trigger point identified in the participant's upper back.
The researcher's thumb or index finger will apply a deep manual pressure such that the participant rates the pain = 50/100 on a 101-point numeric pain rating scale with 0 indicating no pain and 100 indicating the most severe pain imaginable.
The participant will be asked to rate his or her pain during the massage so the pressure may be adjusted to maintain the 50/100 related pain.
Massage will be applied for 60 seconds, 4 times for a total contact time of 240 seconds.
During each 30 second break in which manual pressure is released, Pressure Pain Threshold (PPT) to the foot will be examined.
PPT will be assessed 2 times immediately after each of the 4 massage applications.
|
Participants will be seated in a chair with his or her shirt on.
Participants will receive 60 seconds of manual pressure applied to the myofascial trigger point identified in the participant's upper back.
The researcher's thumb or index finger will apply a deep manual pressure such that the participant rates the pain = 50/100 on a 101-point numeric pain rating scale with 0 indicating no pain and 100 indicating the most severe pain imaginable.
The participant will be asked to rate his or her pain during the massage so the pressure may be adjusted to maintain the 50/100 related pain.
Massage will be applied for 60 seconds, 4 times for a total contact time of 240 seconds.
During each 30 second break in which manual pressure is released, Pressure Pain Threshold (PPT) to the foot will be examined.
PPT will be assessed 2 times immediately after each of the 4 massage applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pressure Pain Threshold
Time Frame: PPT is applied between minutes 1, 2, 3, and 4 of massage. PPT is also applied at minutes 1,3,5,10,15 after massage. A higher PPT indicates a lessening of pain sensitivity.
|
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point.
Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.
|
PPT is applied between minutes 1, 2, 3, and 4 of massage. PPT is also applied at minutes 1,3,5,10,15 after massage. A higher PPT indicates a lessening of pain sensitivity.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temporal Summation
Time Frame: Applied before massage
|
Mechanical temporal summation will be examined using a neuropen with neurotip.
The neuropen with a neurotip has a semi-sharp point that exerts 40g of pressure.
A series of ten pinpricks applied to the palmar surface of the hand opposite the trigger point identified at the beginning of the study visit (if the trigger point is on the left shoulder, the right palm will be used for this test.).
Participants will rate the pain intensity of each pinprick using a numerical pain rating scale from 0-100 where 0=no pain and 100=worst pain imaginable.
A higher pain rating indicates more pain.
|
Applied before massage
|
Conditioned Pain Modulation
Time Frame: Applied before massage
|
First, PPT will be measured on the foot opposite the trigger point.
Second, the arm on the same of the participant's trigger point will be elevated for one minute.
A blood pressure cuff will be inflated to 270 mmHg and the participant will return his or her arm to the horizontal position.
The participant will repeatedly extend the wrist 20 times with a light weight.
Third, PPT will be repeated on the top of the foot.
|
Applied before massage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Abigail Wilson, UCF
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)
June 21, 2022
Primary Completion (ACTUAL)
July 12, 2022
Study Completion (ACTUAL)
July 12, 2022
Study Registration Dates
First Submitted
March 21, 2022
First Submitted That Met QC Criteria
March 30, 2022
First Posted (ACTUAL)
April 8, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 14, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1
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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