Response to Massage in Neck Pain

NCT06224829 | Recruiting

• 1 other identifier: IRB202301891
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Outcome Measures

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)

  Baseline and immediately following the intervention

Secondary Outcomes (2)

• Numeric Pain Rating Scale Resting Pain

  Baseline, immediately following intervention

• Numeric Pain Rating Scale Movement Evoked Pain

  Baseline, immediately following intervention

Study Arms (3)

Pain Inducing Massage

EXPERIMENTAL

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

Pain Free Massage

ACTIVE COMPARATOR

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

Cold Water Bath

ACTIVE COMPARATOR

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

Pain Inducing Massage PROCEDURE

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

Pain Inducing Massage

Pain Free Massage PROCEDURE

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

Pain Free Massage

Cold Water Bath PROCEDURE

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.

Cold Water Bath

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joel Bialosky, PT, PhD

CONTACT

352-733-1162; bialosky@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: April 8, 2024
• Primary Completion (Estimated): July 22, 2026
• Study Completion (Estimated): July 22, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

US (1)