Response to Massage in Neck Pain

Neck Pain Clinical Trial

Official title:

Characterizing Responses to Massage in Individuals With Neck Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224829
• Other study ID #: IRB202301891
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: March 22, 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: Joel Bialosky, PT, PhD
• Phone: 352-733-1162
• Email: bialosky[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: March 22, 2025
• Est. primary completion date: March 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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
• 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
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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