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Pain Modulatory Profiles in Massage for Healthy Participants

Primary Purpose

Healthy, Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Inducing Massage
Pain Free Massage
Coldpressor
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy focused on measuring conditioned pain modulation (CPM), diffuse noxious inhibitory control (DNIC), massage, hypoalgesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Pain Inducing Massage

Pain Free Massage

Coldpressor

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Pressure Pain Threshold
Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful

Secondary Outcome Measures

Change from baseline in Thermal Pain Threshold and Tolerance
Temperature at which ascending thermal stimulus first changes from warm to painful and maximum temperature tolerated
Change from baseline in Pressure Pain Tolerance
Pressure in kilograms at which ascending pressure is no longer tolerated
Change from baseline in Ramp and Hold
Participants will rate their pain using a 101 point mechanical visual analog scale to thermal stimuli of 45, 47, 49, and 50 degree Celsius each of 5 seconds duration will be applied to the forearm and to the muscle on the side of the neck
Change from baseline in Temporal Summation
Participants will rate their pain using a 0 to 10 numeric rating scale to a train of 10 50 degree Celsius heat pulses will be applied to the skin in the plantar surface of the hand.
Change from baseline in Conditioned Pain Modulation
Pressure in kilograms at which ascending pressure stimulus applied to the foot first changes from pressure to painful both prior to and immediately following immersion of the opposite hand in a cold water bath

Full Information

First Posted
March 21, 2018
Last Updated
December 12, 2018
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03490474
Brief Title
Pain Modulatory Profiles in Massage for Healthy Participants
Official Title
Pain Modulatory Profiles in Massage for Healthy Participants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Conditioned pain modulation (CPM) is the physical manifestation of the diffuse noxious inhibitory control (DNIC), an endogenous pain inhibitory pathway in which pain inhibits pain. Conditioned pain modulation is less efficient in individuals with chronic pain conditions and it is a predictor for the development of chronic pain. Massage is a common manual therapy intervention for individuals with musculoskeletal pain. Greater changes in pain sensitivity occur following pain inducing massage suggesting a mechanism dependent upon the efficiency of the conditioned pain modulation response. The study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. Healthy participants will be randomly assigned to receive a pain inducing massage, a pain free massage, or participate in a coldpressor task. Pre-and post intervention pain sensitivity including conditioned pain modulation will be assessed. The study team will determine if analgesia induced by massage is similar to the conditioned pain modulation paradigm and compare changes in pain sensitivity between groups. Previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation. However, this study will be the first to systematically investigate if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm. Furthermore, this study will be the first to determine the association between baseline conditioned pain modulation and massage related hypoalgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Musculoskeletal Pain
Keywords
conditioned pain modulation (CPM), diffuse noxious inhibitory control (DNIC), massage, hypoalgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Inducing Massage
Arm Type
Experimental
Arm Description
Participants will receive manual pressure applied to one myofascial trigger point.
Arm Title
Pain Free Massage
Arm Type
Active Comparator
Arm Description
Participants will receive light touch applied to one myofascial trigger point.
Arm Title
Coldpressor
Arm Type
Placebo Comparator
Arm Description
Participants will place hand into water cooled to 6 degrees Celsius (males) or 8 degrees Celsius (females).
Intervention Type
Other
Intervention Name(s)
Pain Inducing Massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pain Free Massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Coldpressor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in Pressure Pain Threshold
Description
Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change from baseline in Thermal Pain Threshold and Tolerance
Description
Temperature at which ascending thermal stimulus first changes from warm to painful and maximum temperature tolerated
Time Frame
2 hours
Title
Change from baseline in Pressure Pain Tolerance
Description
Pressure in kilograms at which ascending pressure is no longer tolerated
Time Frame
2 hours
Title
Change from baseline in Ramp and Hold
Description
Participants will rate their pain using a 101 point mechanical visual analog scale to thermal stimuli of 45, 47, 49, and 50 degree Celsius each of 5 seconds duration will be applied to the forearm and to the muscle on the side of the neck
Time Frame
2 hours
Title
Change from baseline in Temporal Summation
Description
Participants will rate their pain using a 0 to 10 numeric rating scale to a train of 10 50 degree Celsius heat pulses will be applied to the skin in the plantar surface of the hand.
Time Frame
2 hours
Title
Change from baseline in Conditioned Pain Modulation
Description
Pressure in kilograms at which ascending pressure stimulus applied to the foot first changes from pressure to painful both prior to and immediately following immersion of the opposite hand in a cold water bath
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pain free blood pressure under 140/90 mmHg ability of therapist to locate necessary trigger points on participant Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Bialosky, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Modulatory Profiles in Massage for Healthy Participants

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