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Pain Modulatory Profiles in Massage for Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490474
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment Phase
Healthy Musculoskeletal Pain Other: Pain Inducing Massage Other: Pain Free Massage Other: Coldpressor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pain Modulatory Profiles in Massage for Healthy Participants
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Arm Intervention/treatment
Experimental: Pain Inducing Massage
Participants will receive manual pressure applied to one myofascial trigger point.
Other: Pain Inducing Massage
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.

Active Comparator: Pain Free Massage
Participants will receive light touch applied to one myofascial trigger point.
Other: Pain Free Massage
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.

Placebo Comparator: Coldpressor
Participants will place hand into water cooled to 6 degrees Celsius (males) or 8 degrees Celsius (females).
Other: Coldpressor
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 Measures :
  1. Change from baseline in Pressure Pain Threshold [ Time Frame: 2 hours ]
    Pressure in kilograms at which ascending pressure stimulus first changes from pressure to painful


Secondary Outcome Measures :
  1. Change from baseline in Thermal Pain Threshold and Tolerance [ Time Frame: 2 hours ]
    Temperature at which ascending thermal stimulus first changes from warm to painful and maximum temperature tolerated

  2. Change from baseline in Pressure Pain Tolerance [ Time Frame: 2 hours ]
    Pressure in kilograms at which ascending pressure is no longer tolerated

  3. Change from baseline in Ramp and Hold [ Time Frame: 2 hours ]
    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

  4. Change from baseline in Temporal Summation [ Time Frame: 2 hours ]
    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.

  5. Change from baseline in Conditioned Pain Modulation [ Time Frame: 2 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490474


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Joel Bialosky, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03490474    
Other Study ID Numbers: IRB201800213
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
conditioned pain modulation (CPM)
diffuse noxious inhibitory control (DNIC)
massage
hypoalgesia
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations