Clinical trial NCT03490474: Pain Modulatory Profiles in Massage for Healthy Participants
Official title: Pain Modulatory Profiles in Massage for Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Musculoskeletal Pain
Keywords: conditioned pain modulation (CPM)
diffuse noxious inhibitory control (DNIC)
massage
hypoalgesia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in Pressure Pain Threshold
timeFrame: 2 hours
Secondary outcomes:
measure: Change from baseline in Thermal Pain Threshold and Tolerance
timeFrame: 2 hours
measure: Change from baseline in Pressure Pain Tolerance
timeFrame: 2 hours
measure: Change from baseline in Ramp and Hold
timeFrame: 2 hours
measure: Change from baseline in Temporal Summation
timeFrame: 2 hours
measure: Change from baseline in Conditioned Pain Modulation
timeFrame: 2 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Joel Bialosky, PhD
role: PRINCIPAL_INVESTIGATOR
References: