Low Back PainNCT03169140
Effect of at Home Pain Management Products on Acute Low Back Pain, Disability, and Range of Motion
A study testing TheraBand Kinesiology Tape, Biofreeze and Advice in people with Low Back Pain and Acute Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Acute Pain
- What is being tested?
- TheraBand Kinesiology Tape, Biofreeze and Advice
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low back pain for less than 2 weeks and 18 years of age or older
Who cannot join
- pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain, Acute Pain
- Being tested
- TheraBand Kinesiology Tape, Biofreeze, Advice
- Keywords
- pain management, topical analgesic, acute low back pain, kinesiology tape
- Medical subject headings
- Low Back Pain, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBand Kinesiology TapeDevice
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.
BiofreezeDevice
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.
AdviceBehavioural
An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Receive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management. Receives: 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. Receives: Device: TheraBand Kinesiology Tape |
| Group 3 | Active comparator | Receive a topical product, Biofreeze, to use for one week for at home pain management Receives: Device: Biofreeze |
| Group 4 | Active comparator | Receive advice sheet outlining at home pain management strategies to use for one week. Receives: Behavioral: Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale (NPRS) over one week
Measured: 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
Measured: Baseline (T1), 1 week (T4)
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week
Measured: 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
Measured: Baseline (T1), 1 week (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start14 Feb 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: Decided not to proceed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169140
- Sponsor's protocol ID
- Low Back Home Care
- Status last verified
- Jul 2024
- First submitted
- 16 May 2017
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofreeze®, TheraBand® Kinesiology Tape, or the Combination of Products on Acute Low Back Pain, Disability, and Range of Motion
- ClinicalTrials.gov ID
- NCT03169140
- Acronym / sponsor ID
- Low Back Home Care
- Conditions
- Low Back Pain, Acute Pain
- Keywords
- pain management, topical analgesic, acute low back pain, kinesiology tape
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decided not to proceed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: TheraBand Kinesiology Tape, Device: BiofreezeReceive a combination of products (TheraBand Kinesiology Tape and Biofreeze) to use for one week for at home pain management. |
| Group 2 | Active comparator | Device: TheraBand Kinesiology TapeReceive TheraBand Kinesiology Tape product to use for one week for at home pain management. |
| Group 3 | Active comparator | Device: BiofreezeReceive a topical product, Biofreeze, to use for one week for at home pain management |
| Group 4 | Active comparator | Behavioral: AdviceReceive advice sheet outlining at home pain management strategies to use for one week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- low back pain for less than 2 weeks and 18 years of age or older
Key exclusion criteria (1 listed)
- pregnancy, cancer, or a corticosteroid injection within the past 2 weeks and a history of low back surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraBand Kinesiology TapeA 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. | Device | Group 1, Group 2 |
| BiofreezeThe 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. | Device | Group 1, Group 3 |
| AdviceAn at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week. | Behavioural | Group 4 |
Primary outcome
Change in Numeric Pain Rating Scale (NPRS) over one week
Time frame: 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
Time frame: Baseline (T1), 1 week (T4)
Change in Fear Avoidance Beliefs Questionnaire (FABQ) over one week
Time frame: Baseline (T1), 1 week (T4)
Change in lumbar range of motion over one week
Time frame: Baseline (T1), 1 week (T4)
Using the DorsaVi sensor technology lumbar flexion, extension, and side bending will be measures
Results and safety
The study was stopped early (reason given: Decided not to proceed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraBand Kinesiology Tape, Biofreeze and Advice in people with Low Back Pain and Acute Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decided not to proceed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (NPRS) over one week (time frame: Baseline (T1), Day 2 (T2), Day 4 (T3), 1 week (T4)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.