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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169140
• Other study ID #: Low Back Home Care
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: February 14, 2019

Study information

• Verified date: October 2019
• Source: Sport and Spine Rehab Clinical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 14, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Low Back Pain

Intervention

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.
• 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.

Behavioral:
• Advice
An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.

Locations

Country	Name	City	State
United States	Sport and Spine Rehab	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numeric Pain Rating Scale (NPRS) over one week		Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)
Primary	Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week		Baseline (T1), 1 week (T4)
Primary	Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week		Baseline (T1), 1 week (T4)
Primary	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)