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

NCT01827306 | Completed Results

• 1 other identifier: SSR01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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

  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.

  4 weeks

Study Arms (2)

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.

Drug: Biofreeze

Control

NO INTERVENTION

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

Interventions

Biofreeze DRUG

Biofreeze

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• mechanical shoulder pain
• candidates for conservative care

You may not qualify if:

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

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (1)

Sport & Spine Rehab

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jena Slaski
• Organization: Sport & Spine Rehab Clinical Research Foundation

jslaski@ssrehab.com

7179915595

Study Officials

• Jay Greenstein, DC

  Sport and Spine Rehab Clinical Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 9, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-01

Locations

US (1)