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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
Marquette University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

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

    First Posted
    January 3, 2017
    Last Updated
    January 4, 2017
    Sponsor
    Marquette University
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    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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