Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion
Immediate and Short-term Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion
1 other identifier
interventional
59
1 country
1
Brief Summary
The purpose of this study to compare the effect of Biofreeze® versus a Placebo on neck pain, disability, fear avoidance, and range of motion prior to and following cervical manipulation over the course of one week among patients with acute neck pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedNovember 1, 2019
October 1, 2019
1.8 years
May 12, 2017
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Numeric Pain Rating Scale (NPRS) at 1 week
Baseline (T1), 10 minutes after application (T2), immediately following manipulation [15 minutes after application] (T3), 1 week (T4)
Change in Neck Disability Index (NDI) at 1 week
Baseline (T1), 1 week (T4)
Change Cervical Range of Motion at 1 week
Using FDA cleared DorsaVi sensor system to measure cervical flexion, extension, side bending, and rotation
Baseline (T1), 1 week (T4)
Study Arms (2)
Experimental
EXPERIMENTALThe experimental group will receive the active product (Biofreeze) over the course of 1 week.
Placebo
SHAM COMPARATORThe placebo will use a product created to mimic the topical analgesic Biofreeze over the course of one week. All active ingredients have been removed.
Interventions
Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied 10 minutes prior to manipulation and at home for 4 times a day for 1 week
The placebo is the Biofreeze product with all active ingredients removed. The product will be applied 10 minutes prior to manipulation and at home for 4 times a day for 1 week
Eligibility Criteria
You may qualify if:
- neck pain for less than 2 weeks and \>18 years of age
You may not qualify if:
- pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of neck surgery will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sport and Spine Rehab
Landover, Maryland, 20785, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The placebo and Biofreeze are in identical containers and only the manufacturer know the contents
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 17, 2017
Study Start
March 1, 2017
Primary Completion
December 1, 2018
Study Completion
February 1, 2019
Last Updated
November 1, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share