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

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.

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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