Low Back Pain, Acute Pain
Conditions
Keywords
pain management, topical analgesic, acute low back pain, kinesiology tape
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.
Interventions
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.
DEVICEBiofreeze
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.
BEHAVIORALAdvice
An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.
Sponsors
Sport and Spine Rehab Clinical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (T1), 1 week (T4) | Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures |
Countries
United States
Outcome results
None listed