Pain Modulatory Profiles in Massage for Healthy Participants

NCT ID: NCT03490474

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2018-12-12

Brief Summary

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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

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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.

Conditions

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Healthy Musculoskeletal Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Pain Inducing Massage

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

Group Type EXPERIMENTAL

Pain Inducing Massage

Intervention Type OTHER

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 Free Massage

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

Group Type ACTIVE_COMPARATOR

Pain Free Massage

Intervention Type OTHER

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.

Coldpressor

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

Group Type PLACEBO_COMPARATOR

Coldpressor

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joel Bialosky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201800213

Identifier Type: -

Identifier Source: org_study_id