The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioFreeze
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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:
- Patients not receiving a cervical manipulation
- Patients with radicular signs and/or symptoms
- Patients who did not consent to be in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Treatment
Arm Description
Five minutes before cervical manipulation, controls received a placebo gel applied to their neck.
Five minutes before cervical manipulation the treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
Outcomes
Primary Outcome Measures
Change in Pain over 5 time points
Participants rated their neck pain on a 10-point scale
Secondary Outcome Measures
neck range of motion
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03012503
Brief Title
The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain
Official Title
The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marquette University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Five minutes before cervical manipulation, controls received a placebo gel applied to their neck.
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Five minutes before cervical manipulation the treatment group received a menthol containing gel (Biofreeze®) applied to their neck.
Intervention Type
Drug
Intervention Name(s)
BioFreeze
Intervention Description
The estimated surface area of the average adult's neck is 350cm and the standard dose of Biofreeze® to achieve a clinically significant effect has been sited to be 1ml/200cm2 of skin surface area. Using this data approximately 1.75 ml of the assigned gel was applied to each participant's neck (posterior, anterior, left lateral and right lateral) by the same member of the research team, 5 minutes prior to an independent practitioner performing cervical manipulation on the participant.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
control gel with a similar packaging, texture, and scent as Brand X but without the active ingredient of menthol
Primary Outcome Measure Information:
Title
Change in Pain over 5 time points
Description
Participants rated their neck pain on a 10-point scale
Time Frame
Prior to gel application (Pre) and at one minute (T1), 10 minutes (T2), 20 minutes (T3), and 30 minutes (T4) post cervical manipulation
Secondary Outcome Measure Information:
Title
neck range of motion
Description
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.
Time Frame
Prior to gel application (Pre) and at one minute (T1), and 30 minutes (T4) post cervical manipulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Patients not receiving a cervical manipulation
Patients with radicular signs and/or symptoms
Patients who did not consent to be in the study.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Through publication and/or requests to the PI
Learn more about this trial
The Effect of Biofreeze on Post Manipulation Soreness in Patients With Mechanical Neck Pain
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