Effect of Biofreeze® Versus Placebo on Acute Neck Pain, Disability, and Range of Motion

NCT ID: NCT03157349

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-02-01

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.

Detailed Description

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. Methods: A convenience sample of 60 acute neck pain patients will be recruited at their initial appointment prior to any therapy being applied. Exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of neck surgery will be excluded. Patients will be recruited following their initial examination if they meet the inclusion criteria of pain for less than 2 weeks and be >18 years of age. Eligible patients who agree to participate in the study will complete the informed consent, demographics information questionnaire (including pain medication usage), and paper and pencil instruments that assess their pain, neck disability, and fear avoidance. Cervical range of motion and posture will also be evaluated (T1). After completing the initial paperwork and assessment, patients will then be randomized into either the Placebo [A] (n=30) or Biofreeze® [B] (n=30) group. Both the patient and investigator will be blind to whether topical A or B is the active product. The Biofreeze® group will have Biofreeze® applied directly over the erector spinae muscles of the cervical spine. The Placebo group will have a placebo form of Biofreeze® applied directly over the erector spinae muscles of the cervical spine. After the respective intervention, both groups will wait 10 minutes after the in product is applied to their skin. At the conclusion of the 10 minutes they will again rate their pain (T2). Following the pain rating, all patients will receive a cervical manipulation. Within 5 minutes following the cervical manipulation, all patients will rate their level of pain (T3). Following completion of this rating of pain within 5 minutes following manipulation all subjects will be given the same at-home pain management program. This pain management program will involve applying either Biofreeze® or Placebo to their neck four times per day for the next week based on previous randomization schedule prior to cervical manipulation. All subjects will be instructed to apply the gel they have been assigned directly on top of the erector spinae and site of pain of neck, from inferior to superior to inferior. At one week (T4) patients will complete the paper and pencil instruments and cervical range of motion from the first visit. In addition, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.

Conditions

Acute Pain; Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

The experimental group will receive the active product (Biofreeze) over the course of 1 week.

Group Type: EXPERIMENTAL

Biofreeze

Intervention Type: OTHER

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

Placebo

The placebo will use a product created to mimic the topical analgesic Biofreeze over the course of one week. All active ingredients have been removed.

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Biofreeze

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• neck pain for less than 2 weeks and >18 years of age

Exclusion Criteria

• pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of neck surgery will be excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sport and Spine Rehab

Landover, Maryland, United States

Countries

United States

Other Identifiers

Neck BFvP

Identifier Type: -

Identifier Source: org_study_id