NCT03490474

Brief Summary

One in ten adults experience widespread pain. Neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually. Massage is a common manual therapy intervention for individuals with musculoskeletal pain. However, the mechanisms of massage are not well established. Also, the conditioned pain modulation (CPM) paradigm is a dynamic quantitative sensory testing measure of a pain inhibitory process in which pain sensitivity is lessened in response to a remotely applied painful stimulus. This study will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2018

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, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

March 21, 2018

Last Update Submit

December 12, 2018

Conditions

HealthyMusculoskeletal Pain

Keywords

conditioned pain modulation (CPM)diffuse noxious inhibitory control (DNIC)massagehypoalgesia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Pressure Pain Threshold

    Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful

    2 hours

Secondary Outcomes (5)

  • Change from baseline in Thermal Pain Threshold and Tolerance

    2 hours

  • Change from baseline in Pressure Pain Tolerance

    2 hours

  • Change from baseline in Ramp and Hold

    2 hours

  • Change from baseline in Temporal Summation

    2 hours

  • Change from baseline in Conditioned Pain Modulation

    2 hours

Study Arms (3)

Pain Inducing Massage

EXPERIMENTAL

Participants will receive manual pressure applied to one myofascial trigger point.

Other: Pain Inducing Massage

Pain Free Massage

ACTIVE COMPARATOR

Participants will receive light touch applied to one myofascial trigger point.

Other: Pain Free Massage

Coldpressor

PLACEBO COMPARATOR

Participants will place hand into water cooled to 6 degrees Celsius (males) or 8 degrees Celsius (females).

Other: Coldpressor

Interventions

Pain Inducing MassageOTHER

Participants will receive 60 seconds of manual pressure applied to one myofascial trigger point so the participant rates the pain = 5/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.

Pain Inducing Massage
Pain Free MassageOTHER

Participants will receive 60 seconds of light touch applied to one myofascial trigger point so the participant rates the pain = 0/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.

Pain Free Massage
ColdpressorOTHER

Participants will place their non-dominant hand into water cooled by a refrigeration unit temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times.

Coldpressor

Eligibility Criteria

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

You may qualify if:

  • pain free
  • blood pressure under 140/90 mmHg
  • ability of therapist to locate necessary trigger points on participant

You may not qualify if:

  • blood pressure over 140/90 mmHg
  • inability of therapist to locate necessary trigger points on participant
  • 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
  • any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joel Bialosky, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

April 6, 2018

Study Start

April 16, 2018

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)