Pain Modulatory Profiles in Massage for Individuals With Neck Pain

NCT03534739 | Completed

• 1 other identifier: IRB201800840
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Pain; Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Pressure Pain Threshold

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

  2 hours

Secondary Outcomes (5)

• Change from baseline in Thermal Pain Threshold and Tolerance

  2 hours

• Change from baseline in Pressure Pain Tolerance

  2 hours

• Change from baseline in Ramp and Hold

  2 hours

• Change from baseline in Temporal Summation

  2 hours

• Change from baseline in Conditioned Pain Modulation

  2 hours

Study Arms (3)

Pain Inducing Massage

EXPERIMENTAL

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

Other: Pain Inducing Massage

Light Touch Massage

ACTIVE COMPARATOR

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

Other: Light Touch Massage

Coldpressor

PLACEBO COMPARATOR

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

Other: Coldpressor

Interventions

Pain Inducing Massage 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 Inducing Massage

Light Touch Massage 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.

Light Touch Massage

Coldpressor 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.

Coldpressor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain; Neck Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Bialosky, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or a coldpressor task.

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: June 20, 2018
• Primary Completion: June 9, 2022
• Study Completion: June 9, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)