- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534739
Pain Modulatory Profiles in Massage for Individuals With Neck Pain
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 in participants with a history of neck pain.
Study Overview
Status
Conditions
Intervention / Treatment
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. Previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation.
The study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or a coldpressor task. Pre-and post intervention pain will be assessed. The study team will determine if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm and if baseline conditioned pain modulation predicts responders to pain inducing massage and short term clinical outcomes in patients with a history of neck pain.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32610
- UF Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- currently experiencing neck pain with or without arm pain
- neck pain symptom intensity rated as 4/10 or higher during the last 24 hours
- neck pain for greater than or equal to 3 months
Exclusion Criteria:
- non-English speaking
- systemic medical conditions known to affect sensation (e.g. diabetes, hypertension)
- history of neck surgery or fracture within the past 6 months
- current history of chronic pain condition other than neck pain
- diagnosis of cervical radiculopathy or cervical myelopathy
- history of whiplash; g) currently using blood thinning medication
- any blood clotting disorder such as hemophilia
- any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain Inducing Massage
Participants will receive manual pressure applied to one myofascial trigger point.
|
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: Light Touch Massage
Participants will receive light touch applied to one myofascial trigger point.
|
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).
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 hours
|
Change from baseline in Pressure Pain Tolerance
Time Frame: 2 hours
|
Pressure in kilograms at which ascending pressure is no longer tolerated
|
2 hours
|
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
|
2 hours
|
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.
|
2 hours
|
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
|
2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joel Bialosky, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201800840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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