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

NCT ID: NCT01827306

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-07-31

Brief 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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biofreeze

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.

Group Type: ACTIVE_COMPARATOR

Biofreeze

Intervention Type: DRUG

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Biofreeze

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay Greenstein, DC

Role: PRINCIPAL_INVESTIGATOR

Sport and Spine Rehab Clinical Research Foundation

Locations

Sport & Spine Rehab

Rockville, Maryland, United States

Countries

United States

Other Identifiers

SSR01

Identifier Type: -

Identifier Source: org_study_id