CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Biofreezedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01827306
NCT01827306N/ACompleted

Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance: A Preliminary Pilot Study

Sport and Spine Rehab Clinical Research Foundation·interventional·Posted Apr 9, 2013·Updated Feb 9, 2016

In Brief

A clinical study evaluating Biofreeze for Shoulder Pain. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShoulder Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2013
Enrollment StartMar 1, 2013
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.2 years ago

Interventions

Biofreezedrug