The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Drug: BioFreeze; Drug: Placebos

• Registration Number: NCT03012503
• Lead Sponsor: Marquette University

Brief Summary

Background: Neck pain effects a significant number of individuals and is commonly treated with chiropractic cervical manipulation. The temporary increases in neck pain following cervical manipulation may contribute to a lack of compliance with prescribed therapy that following this therapy which in turn commonly contributes to protracted symptoms. Topical menthol has previously been shown to decrease pain shortly following application. The purpose of this study was to determine if patients with mechanical neck pain who received topical menthol gel applied to their neck prior to cervical manipulation would have less pain and increased neck range of motion following cervical manipulation than patients who did not receive menthol.

Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before cervical manipulation, controls received a placebo gel applied to their neck while the treatment group received a menthol containing gel (Biofreeze®) applied to their neck. Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation. Six measures of neck range of motion were assessed prior to topical applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain ratings and neck range of motion following manipulation while controlling for Pre measures.

Detailed Description

Background: Neck pain effects a significant number of individuals and is commonly treated with chiropractic cervical manipulation. The temporary increases in neck pain following cervical manipulation may contribute to a lack of compliance with prescribed therapy that following this therapy which in turn commonly contributes to protracted symptoms. Topical menthol has previously been shown to decrease pain shortly following application. The purpose of this study was to determine if patients with mechanical neck pain who received topical menthol gel applied to their neck prior to cervical manipulation would have less pain and increased neck range of motion following cervical manipulation than patients who did not receive menthol.

Methods: Patients, mean ages 35 years old, with non-radicular mechanical neck pain were randomly assigned to a control (n=31) or a treatment (n=29) group. Five minutes before cervical manipulation, controls received a placebo gel applied to their neck while the treatment group received a menthol containing gel (Biofreeze®) applied to their neck. Participants rated their neck pain on a 10-point scale prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation. Six measures of neck range of motion were assessed prior to topical applications of gel and at T1 and T4. ANCOVA repeated measures were performed to compare pain ratings and neck range of motion following manipulation while controlling for Pre measures.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-06
• Last Update Posted: 2017-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Individuals were included in the study if they were between the ages of 18-65 years old, presented to their with initial clinic visit with non-radicular mechanical neck pain greater than 3 on a 1-10 pain scale, and were prescribed by the clinical staff to receive a cervical manipulation

Exclusion Criteria

1. Patients not receiving a cervical manipulation
2. Patients with radicular signs and/or symptoms
3. Patients who did not consent to be in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	BioFreeze	Five minutes before cervical manipulation the treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
Control	Placebos	Five minutes before cervical manipulation, controls received a placebo gel applied to their neck.

Primary Outcome Measures

Name	Time	Method
Change in Pain over 5 time points	Prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation	Participants rated their neck pain on a 10-point scale

Secondary Outcome Measures

Name	Time	Method
neck range of motion	Prior to gel application (Pre) and at one minute (T1), and 30 minutes (T4) post cervical manipulation	Six measures of neck range of motion were assessed in the sagittal, frontal, and horizontal planes using the Acumar DataCapture hand-held dual inclinometer. This device has demonstrated a high degree of reliability (.87 - .92) without requiring calibration 21. These assessments included the neck motions of flexion, extension, right side bending, left side bending, left rotation and right rotation.