NCT04108403

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

September 26, 2019

Last Update Submit

September 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Pain Inducing Massage and Positive Expectation Instructions

EXPERIMENTAL

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.

Other: Pain Inducing MassageOther: Positive Expectation Instructional Set

Pain Inducing Massage and Negative Expectation Instructions

ACTIVE COMPARATOR

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.

Other: Pain Inducing MassageOther: Negative Expectation Instructional Set

Pain Free Massage and Positive Expectation Instructions

ACTIVE COMPARATOR

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.

Other: Pain Free MassageOther: Positive Expectation Instructional Set

Pain Free Massage and Negative Expectation Instructions

ACTIVE COMPARATOR

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.

Other: Pain Free MassageOther: Negative Expectation Instructional Set

Interventions

A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.

Pain Inducing Massage and Negative Expectation InstructionsPain Inducing Massage and Positive Expectation Instructions

A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.

Pain Free Massage and Negative Expectation InstructionsPain Free Massage and Positive Expectation Instructions

Participants will be instructed that the massage is effective for some people with neck pain.

Pain Free Massage and Positive Expectation InstructionsPain Inducing Massage and Positive Expectation Instructions

Participants will be instructed that the massage is ineffective for some people with neck pain.

Pain Free Massage and Negative Expectation InstructionsPain Inducing Massage and Negative Expectation Instructions

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. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Wilson AT, Bishop MD, Beneciuk JM, Tilley HE, Riley JL 3rd, Cruz-Almeida Y, Bialosky JE. Expectations affect pain sensitivity changes during massage. J Man Manip Ther. 2023 Apr;31(2):84-92. doi: 10.1080/10669817.2022.2118449. Epub 2022 Sep 7.

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joel Bialosky, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be masked to the type of instructional set received during the intervention. However, participants will be notified of this upon completion of the study.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 30, 2019

Study Start

October 31, 2019

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations