Response to Massage in Neck Pain

Characterizing Responses to Massage in Individuals With Neck Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Pain Inducing Massage; Procedure: Pain Free Massage; Procedure: Cold Water Bath

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Bialosky, PT, PhD; Phone Number: 352-733-1162; Email: bialosky@phhp.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Joel E Bialosky, PhD; Phone Number: 352-273-8636; Email: bialosky@phhp.ufl.edu
      • Principal Investigator: Joel E Bialosky, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and immediately following the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, immediately following intervention
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.	Baseline, immediately following intervention

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: IRB202301891

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No