Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Back Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/1/2018 |
| Start Date: | February 14, 2017 |
| End Date: | September 14, 2018 |
| Contact: | Jena Etnoyer-Slaski, ATC, M.S.Ed |
| Email: | jslaski@ssrehab.com |
| Phone: | 301-251-2777 |
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.
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.
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.
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.
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
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