Clinical trial NCT03534739: Pain Modulatory Profiles in Massage for Individuals With Neck Pain
Official title: Pain Modulatory Profiles in Massage for Individuals With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Neck Pain
Keywords: conditioned pain modulation (CPM)
diffuse noxious inhibitory control (DNIC)
massage
hypoalgesia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or a coldpressor task.
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 in participants with a history of neck pain.

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.

Eligibility criteria: 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.

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: