Clinical trial NCT03169140: 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
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Acute Pain
Keywords: pain management
topical analgesic
acute low back pain
kinesiology tape
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS) over one week
timeFrame: Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)
measure: Change in Roland-Morris Low Back Pain and Disability Questionnaire (RMDQ) over one week
timeFrame: Baseline (T1), 1 week (T4)
measure: Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week
timeFrame: Baseline (T1), 1 week (T4)
measure: Change in lumbar range of motion over one week
timeFrame: Baseline (T1), 1 week (T4)
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport and Spine Rehab
state: Maryland
Study officials:
References: