Pain Modulatory Profiles in Massage for Individuals With Neck Pain

NCT ID: NCT03534739

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-20
• Study Completion Date: 2022-06-09

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.

Conditions

Musculoskeletal Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Light Touch Massage

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

Group Type: ACTIVE_COMPARATOR

Light Touch 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

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

Light Touch 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Bialosky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

UF Health

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201800840

Identifier Type: -

Identifier Source: org_study_id