Shoulder PainBFShld01NCT01827306
Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance
A study testing Biofreeze in people with Shoulder Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial summary
Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Biofreeze
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years old
- mechanical shoulder pain
- candidates for conservative care
Who cannot join
- pregnancy
- radicular symptoms
- not a candidate for conservative care
- history of recent shoulder surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study
Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.
- Conditions
- Shoulder Pain
- Being tested
- Biofreeze
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreezeDrug
| Study group | Role | What they receive |
|---|---|---|
| Biofreeze | Active comparator | Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. Receives: Drug: Biofreeze |
| Control | No intervention | Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks
The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score
Measured: 2 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.
Measured: 2 weeks
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks
The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score
Measured: 4 weeks
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Greenstein, DC, Principal investigator, Sport and Spine Rehab Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827306
- Sponsor's protocol ID
- SSR01
- Acronym
- BFShld01
- Status last verified
- Jan 2016
- First submitted
- 2 Apr 2013
- Last updated
- 9 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study
- ClinicalTrials.gov ID
- NCT01827306
- Acronym / sponsor ID
- BFShld01 / SSR01
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises are considered an important component of care for shoulder pain patients, although pain can be a limiting factor in the advancement of rehabilitation. The purpose of this study is to evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical shoulder pain who are candidates for standard shoulder therapy will be randomized into two groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just prior to initiating the in-office exercise program. Values of pain (NPRS) and disability (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by repeated measures ANOVAs within and between group, time, and interaction main effects. Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the associated disability. The ability to decrease shoulder pain and disability with a topical analgesic will allow health care professionals to advance patients through a therapeutic exercise program without the restriction of pain. In turn, patients will correct the underlying condition of their shoulder pain at a faster rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofreeze | Active comparator | Drug: BiofreezeApply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program. |
| Control | No intervention | –Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-64 years old
- mechanical shoulder pain
- candidates for conservative care
Key exclusion criteria (4 listed)
- pregnancy
- radicular symptoms
- not a candidate for conservative care
- history of recent shoulder 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 |
|---|---|---|
| Biofreeze | Drug | Biofreeze |
Primary outcome
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks
Time frame: 2 weeks
The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score
Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks
Time frame: 2 weeks
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.
Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks
Time frame: 4 weeks
The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score
Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks
Time frame: 4 weeks
The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jay Greenstein, DC principal investigator
Sport and Spine Rehab Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofreeze in people with Shoulder 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks (time frame: 2 weeks). 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 9 Feb 2016.