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

NCT03169140 | Terminated FDA Device

• 1 other identifier: Low Back Home Care
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Acute Pain

Keywords

pain management; topical analgesic; acute low back pain; kinesiology tape

Outcome Measures

Primary Outcomes (4)

• 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

  Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures

  Baseline (T1), 1 week (T4)

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management.

Device: TheraBand Kinesiology Tape; Device: Biofreeze

Group 2

ACTIVE COMPARATOR

Receive TheraBand Kinesiology Tape product to use for one week for at home pain management.

Device: TheraBand Kinesiology Tape

Group 3

ACTIVE COMPARATOR

Receive a topical product, Biofreeze, to use for one week for at home pain management

Device: Biofreeze

Group 4

ACTIVE COMPARATOR

Receive advice sheet outlining at home pain management strategies to use for one week.

Behavioral: Advice

Interventions

TheraBand Kinesiology Tape DEVICE

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.

Group 1; Group 2

Biofreeze DEVICE

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.

Group 1; Group 3

Advice BEHAVIORAL

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

Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for less than 2 weeks and 18 years of age or older

You may not qualify if:

• pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (1)

Sport and Spine Rehab

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Low Back Pain; Acute Pain; Agnosia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 30, 2017
• Study Start: February 14, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)