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NCT01827306 · ClinicalTrials.gov registry record · NA

Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance

A NA study, sponsored by Sport and Spine Rehab Clinical Research Foundation.

Completed
Registry status
NA
Development phase
34
Enrollment target

NCT01827306 is a NA study that has completed, run by Sport and Spine Rehab Clinical Research Foundation. The registered enrollment target is 34 participants.

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The verdict

NCT01827306, a NA study, has completed, sponsored by Sport and Spine Rehab Clinical Research Foundation.

COMPLETED
Registry status
NA
Development phase
34 participants
Enrollment target

Study 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 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.

Interventions

  • DRUG Biofreeze

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2013-03
Est. Completion 2014-07
Phase NA

What the Registry Record Tells You About NCT01827306

The ClinicalTrials.gov registry entry for NCT01827306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sport and Spine Rehab Clinical Research Foundation, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Biofreeze is the first listed.

NCT01827306 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01827306 about?

NCT01827306 is a clinical study titled "Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance". 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 t...

What is the current status of trial NCT01827306?

This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2013-03. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01827306?

The interventions under investigation include: Biofreeze (DRUG).

Who is sponsoring clinical trial NCT01827306?

This trial is sponsored by Sport and Spine Rehab Clinical Research Foundation, which has 16 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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