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

Not Applicable

Terminated

• Conditions: Low Back Pain; Acute Pain
• Interventions: Device: TheraBand Kinesiology Tape; Device: Biofreeze; Behavioral: Advice

• Registration Number: NCT03169140
• Lead Sponsor: Sport and Spine Rehab Clinical Research Foundation

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.

Study Timeline

• Study Start: 2017-02-14
• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Status Verified: 2024-07
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	TheraBand Kinesiology Tape	Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.
Group 3	Biofreeze	Receive a topical product, Biofreeze, to use for one week for at home pain management
Group 4	Advice	Receive advice sheet outlining at home pain management strategies to use for one week.
Group 1	Biofreeze	Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.
Group 2	TheraBand Kinesiology Tape	Receive TheraBand Kinesiology Tape product to use for one week for at home pain management.

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Sport and Spine Rehab; 🇺🇸 Rockville, Maryland, United States