Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance (BFShld01)

Sport and Spine Rehab Clinical Research Foundation

Status: Completed

Conditions: Shoulder Pain

Treatments: Drug: Biofreeze

Study type: Interventional

Funder types: Other

Identifiers

NCT01827306

SSR01

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-64 years old
• mechanical shoulder pain
• candidates for conservative care

Exclusion criteria

• pregnancy
• radicular symptoms
• not a candidate for conservative care
• history of recent shoulder surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Biofreeze

Active Comparator group

Description:

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.

Treatment:

Drug: Biofreeze

Control

No Intervention group

Description:

Subjects in this arm will complete a standard shoulder therapy program as normal, with no intervention.