Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
Primary Purpose
Low Back Pain, Acute Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TheraBand Kinesiology Tape
Biofreeze
Advice
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring pain management, topical analgesic, acute low back pain, kinesiology tape
Eligibility Criteria
Inclusion Criteria:
- low back pain for less than 2 weeks and 18 years of age or older
Exclusion Criteria:
- pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery
Sites / Locations
- Sport and Spine Rehab
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.
Receive TheraBand Kinesiology Tape product to use for one week for at home pain management.
Receive a topical product, Biofreeze, to use for one week for at home pain management
Receive advice sheet outlining at home pain management strategies to use for one week.
Outcomes
Primary Outcome Measures
Change in Numeric Pain Rating Scale (NPRS) over one week
Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week
Change in lumbar range of motion over one week
Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03169140
First Posted
May 16, 2017
Last Updated
October 30, 2019
Sponsor
Sport and Spine Rehab Clinical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03169140
Brief Title
Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
Official Title
Effect of Biofreeze®, TheraBand® Kinesiology Tape, or the Combination of Products on Acute Low Back Pain, Disability, and Range of Motion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
February 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of a combination of separate therapies of Biofreeze® and TheraBand Kinesiology Tape to advice on acute pain, disability and fear avoidance among low back patients over a 1-week period of time.
Detailed Description
A convenience sample of 120 acute low back pain patients will be recruited from Sport and Spine Rehab at their initial appointment. Exclusionary criteria will include pregnancy, cancer, or a corticosteroid injection within the past 2 weeks. Additionally, anyone who has a history of low back surgery will be excluded. Patients will be recruited following their initial examination if they meet the inclusion criteria of reporting low back pain for less than 2 weeks and be >18 years of age. Patients will complete the informed consent, demographics information questionnaire, Numeric Pain Rating Scale (NPRS), Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), Fear Avoidance Beliefs Questionnaire (FABQ). Following paper documents their lumbar range of motion and posture will be analyzed using the DorsaVi ViMove device [http://us.dorsavi.com/vimove/] (T1). After completing T1, patients will then be randomized into 1 of 4 at-home pain management groups (n=30 per group), to be followed for one week. Group 1 (Biofreeze® + Tape), Group 2 (Tape Only), Group 3 (Biofreeze Only), and Group 4 (Advice Alone). Treatment at the first office visit will be standardized to include manipulation only; no in-office therapy will be provided to either group at the first visit. Upon returning for their 2nd (T2), and 3rd (T3) office visits, all patients will rate their pain (NPRS). At one week (T4) patients will complete the paper and pencil instruments from the first visit, which assess the subjects' pain on the Numeric Pain Rating Scale (NPRS), low back disability on the Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ), and fear on the Fear Avoidance Beliefs Questionnaire (FABQ). Lumbar range of motion and posture will also be reassessed. In addition,, at home pain management compliance and pain medication will be documented on a daily basis for the entire week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Acute Pain
Keywords
pain management, topical analgesic, acute low back pain, kinesiology tape
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Receive TheraBand Kinesiology Tape product to use for one week for at home pain management.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
Receive a topical product, Biofreeze, to use for one week for at home pain management
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Receive advice sheet outlining at home pain management strategies to use for one week.
Intervention Type
Device
Intervention Name(s)
TheraBand Kinesiology Tape
Intervention Description
A 20 cm strip of tape will be applied to each side of the low back directly over the erector spinae muscles at the site of pain. This tape will remain there, and be reapplied when necessary, for one week.
Intervention Type
Device
Intervention Name(s)
Biofreeze
Intervention Description
The topical analgesic will be sprayed directly on top of the erector spinae and site of pain low back directly, from inferior to superior to inferior 4 times a day for one week.
Intervention Type
Behavioral
Intervention Name(s)
Advice
Intervention Description
An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.
Primary Outcome Measure Information:
Title
Change in Numeric Pain Rating Scale (NPRS) over one week
Time Frame
Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)
Title
Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week
Time Frame
Baseline (T1), 1 week (T4)
Title
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week
Time Frame
Baseline (T1), 1 week (T4)
Title
Change in lumbar range of motion over one week
Description
Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures
Time Frame
Baseline (T1), 1 week (T4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
low back pain for less than 2 weeks and 18 years of age or older
Exclusion Criteria:
pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery
Facility Information:
Facility Name
Sport and Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
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