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CompletedNCT03490474Updated Dec 13, 2018

Pain Modulatory Profiles in Massage for Healthy Participants

An interventional study of Pain Inducing Massage and Pain Free Massage in Healthy and Musculoskeletal Pain, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by University of Florida · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy
  • Musculoskeletal Pain

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Keywords

  • conditioned pain modulation (CPM)
  • diffuse noxious inhibitory control (DNIC)
  • massage
  • hypoalgesia
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Pain Inducing Massage

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

    Other: Pain Inducing Massage

  • Active comparator
    Pain Free Massage

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

    Other: Pain Free Massage

  • Placebo comparator
    Coldpressor

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

    Other: Coldpressor

Interventions

  • OtherPain 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.

  • OtherPain 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.

  • OtherColdpressor

    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.

05

What researchers measure

Primary outcomes

  1. Change from baseline in Pressure Pain Threshold

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

    Time frame: 2 hours

Secondary outcomes

  1. 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

    Time frame: 2 hours

  2. Change from baseline in Pressure Pain Tolerance

    Pressure in kilograms at which ascending pressure is no longer tolerated

    Time frame: 2 hours

  3. 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

    Time frame: 2 hours

  4. 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.

    Time frame: 2 hours

  5. 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

    Time frame: 2 hours

06

Study locations

1 site
  • UF Health
    Gainesville, Florida 32610, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03490474
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Apr 16, 2018
Primary completion
Dec 12, 2018
Completion
Dec 12, 2018
Last update
Dec 13, 2018

Study contacts

Joel Bialosky, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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