NCT05317702

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

21 days

First QC Date

March 21, 2022

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pressure Pain Threshold

    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 Outcomes (2)

  • Temporal Summation

    Applied before massage

  • Conditioned Pain Modulation

    Applied before massage

Study Arms (1)

Moderately Painful Massage

EXPERIMENTAL

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.

Other: Moderately Painful Massage

Interventions

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.

Moderately Painful Massage

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pain-free

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32765, United States

Location

Study Officials

  • Abigail Wilson

    UCF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 8, 2022

Study Start

June 21, 2022

Primary Completion

July 12, 2022

Study Completion

July 12, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations