Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion

Effect of Biofreeze®, TheraBand® Kinesiology Tape, or the Combination of Products on Acute Low Back Pain, Disability, and Range of Motion

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Acute Pain
• Intervention / Treatment: Device: TheraBand Kinesiology Tape; Device: Biofreeze; Behavioral: Advice

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Sport and Spine Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.	Device: TheraBand Kinesiology Tape; 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.; Device: Biofreeze; 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.
Active Comparator: Group 2; Receive TheraBand Kinesiology Tape product to use for one week for at home pain management.	Device: TheraBand Kinesiology Tape; 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.
Active Comparator: Group 3; Receive a topical product, Biofreeze, to use for one week for at home pain management	Device: Biofreeze; 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.
Active Comparator: Group 4; Receive advice sheet outlining at home pain management strategies to use for one week.	Behavioral: Advice; An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale (NPRS) over one week		Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)
Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week		Baseline (T1), 1 week (T4)
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week		Baseline (T1), 1 week (T4)
Change in lumbar range of motion over one week	Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures	Baseline (T1), 1 week (T4)

Collaborators and Investigators

• Sponsor: Sport and Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: pain management; acute low back pain; topical analgesic; kinesiology tape
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Acute Pain
• Other Study ID Numbers: Low Back Home Care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes