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RecruitingNCT06224829Updated Sep 30, 2026

Response to Massage in Neck Pain

An interventional study of Pain Inducing Massage and Pain Free Massage in Neck Pain, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study is interested in whether baseline measures of pain sensitivity i.e. the amount of pressure required to feel pain predicts pain relief following a pain inducing massage AND whether pain relief following a pain inducing massage is different than a pain free massage or placing your hand in a cold water bath. Participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or to place their hand in a cold water bath.

02

Conditions studied

  • Neck Pain

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03

Who can participate

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

Inclusion criteria

  • Age 18 to 60 years old
  • 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)
  • 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
  • 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
  • Pregnancy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
53 participants (estimated)

Study arms

  • Experimental
    Pain Inducing Massage

    Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 5/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable.

    Procedure: Pain Inducing Massage

  • Active comparator
    Pain Free Massage

    Participants will receive 60 seconds of manual pressure applied to one point in their neck followed by 30 seconds of complete pressure release 4 times for a total contact time of 240 seconds. Pressure will be applied such that the participant rates the pain = 0/10 on an 11-point numeric pain rating scale with 0 indicating no pain and 10 indicating the most severe pain imaginable.

    Procedure: Pain Free Massage

  • Active comparator
    Cold Water Bath

    Participants will place their non-dominant hand into water cooled by a refrigeration unit (NESLAB RTE 7 Digital One, Thermo Scientific Co., Massachusetts, USA) that circulates water continuously to maintain a constant 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 for a total immersion time of 240 seconds.

    Procedure: Cold Water Bath

Interventions

  • ProcedurePain Inducing Massage

    60 seconds of direct pressure to the neck resulting in 5/10 pain . This will be repeated four times for a total of 240 seconds

  • ProcedurePain Free Massage

    60 seconds of direct pressure to the neck resulting in 0/10 pain . This will be repeated four times for a total of 240 seconds

  • ProcedureCold Water Bath

    Participants will place their hand in a cold water bath maintained at 6 to 8 degrees Celsius for 60 seconds. This will be repeated four times for a total of 240 seconds.

05

What researchers measure

Primary outcomes

  1. Pressure Pain Threshold

    Pressure applied to the web space of the foot with a digital pressure algometer applied at 1 kg/s. Participants will be instructed to indicate when the sensation first changes from pressure to pain (pain threshold)

    Time frame: Baseline and immediately following the intervention

Secondary outcomes

  1. Numeric Pain Rating Scale Resting Pain

    Participants will rate their "current" neck pain on a 0 to 100 scale with 0= no pain and 100= the most intense pain imaginable

    Time frame: Baseline, immediately following intervention

  2. Numeric Pain Rating Scale Movement Evoked Pain

    Participants will rate their neck pain on a 0 to 100 scale with 0= no pain and 100= the most intense pain imaginable during active cervical spine range of motion. The average rating across all motions (flexion, extension, left and right sidebend, left and right rotation) will be used in the analysis.

    Time frame: Baseline, immediately following intervention

06

Study locations

1 of 1 sites recruiting
  • University of Florida
    Gainesville, Florida 32610, United States
    • Joel E Bialosky, PhD · Contact · bialosky@phhp.ufl.edu · 352-273-8636
    • Joel E Bialosky, PhD · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06224829
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Jan 25, 2024
Start date
Apr 8, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

Joel Bialosky, PT, PhD
Contact
bialosky@phhp.ufl.edu
352-733-1162

Oversight

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

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