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CompletedNCT03534739Updated Jul 7, 2022

Pain Modulatory Profiles in Massage for Individuals With Neck Pain

An interventional study of Pain Inducing Massage and Light Touch Massage in Musculoskeletal Pain and Neck Pain, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by University of Florida · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Musculoskeletal Pain
  • Neck Pain

Keywords

  • conditioned pain modulation (CPM)
  • diffuse noxious inhibitory control (DNIC)
  • massage
  • hypoalgesia
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 26 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Pain Inducing Massage

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

    Other: Pain Inducing Massage

  • Active comparator
    Light Touch Massage

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

    Other: Light Touch Massage

  • Placebo comparator
    Coldpressor

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

    Other: Coldpressor

Interventions

  • OtherPain 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.

  • OtherLight 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.

  • OtherColdpressor

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Pressure Pain Threshold

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

    Time frame: 2 hours

Secondary outcomes

  1. Change from baseline in Thermal Pain Threshold and Tolerance

    Temperature at which ascending thermal stimulus first changes from warm to painful and maximum temperature tolerated

    Time frame: 2 hours

  2. Change from baseline in Pressure Pain Tolerance

    Pressure in kilograms at which ascending pressure is no longer tolerated

    Time frame: 2 hours

  3. Change from baseline in Ramp and Hold

    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

    Time frame: 2 hours

  4. Change from baseline in Temporal Summation

    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.

    Time frame: 2 hours

  5. Change from baseline in Conditioned Pain Modulation

    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

    Time frame: 2 hours

07

Study locations

1 site
  • UF Health
    Gainesville, Florida 32610, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03534739
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
May 23, 2018
Start date
Jun 20, 2018
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022
Last update
Jul 7, 2022

Study contacts

Joel Bialosky, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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