Cramer Sports Motion Tape and Low Back Pain EMG

NCT ID: NCT02122445

Last Updated: 2016-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

Brief Summary

Low back pain is a problem which affects up to 70-80% of people in their lifetime. In the United States, it is estimated that the total direct and indirect costs of low back pain combined ranges from $19.6 to $118.8 billion. Recent studies have shown the importance of the gluteal musculature in the treatment of low back pain. It was found that the gluteus maximus (Gmax) is significantly more active in a low back pain population compared to a healthy population, indicating the low back pain population relied on the Gmax to fire more to overcome the gluteal weakness. A new approach to treating musculoskeletal conditions is a taping technique designed to target muscles and lymphatic system. Limited research is available for the treatment of specific conditions, including low back pain, but it is theorized to inhibit or facilitate the muscle, improve blood flow, reduce pain, and improve joint alignment. Methods: The purpose of this study is to determine the immediate and delayed effectiveness of Cramer® Sports Motion Tape on Gmax and lumbar paraspinal activation in a chronic mechanical low back pain population. A convenience sample of 20 new patients with current, chronic low back pain, no current neurologic signs or symptoms, no previous spinal surgery, no corticosteroid treatment within the last two weeks, and who are not pregnant will be recruited for this study. Patients will sign an informed consent, complete all initial paperwork. Surface electromyography will be used to quantify the activity level of the Gmax and lumbar paraspinals (LP). The MVIC will be estimated for each muscle group and the patient will perform a series of 4 randomized exercises, 5 repetitions each; Clams with Resistance, Standing Hip Abduction with Resistance, Sidelying Hip Abduction, and a forward bend. After each exercise the patient will rate "How hard they are working" on the RISE scale. Following the initial test, Cramer® Sports Motion Tape will be applied to the gluteal and low back area. After the tape is applied, the EMG exercise protocol will be repeated. The tape will be left on until the patient returns for their next appointment, within 24 to 48 hours, where they will have a delayed post-test. Patients will rate their pain, surface electrodes will be applied to the previous testing sites, and MVIC will be retested for each muscle group. The patient will perform the same protocol that was performed in the initial testing session. The EMG signals will be smoothed, rectified and analyzed using a root-mean-square algorithm. The investigators will use visual onset and offset of the EMG signal amplitude to select the middle 3 trials. Average activation and peak activation will be determined and compared to the MVIC for each muscle group, and expressed as a %MVIC. This will allow %MVIC to be compared and rank order among groups and muscles.

Conditions

Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Back Pain

Lower body exercises before and after the application of Cramer Sports Motion tape

Group Type: EXPERIMENTAL

Cramer Sports Motion Tape

Intervention Type: DEVICE

lower body exercises with and without Cramer Sports Motion tape applied to the hip

Interventions

Cramer Sports Motion Tape

lower body exercises with and without Cramer Sports Motion tape applied to the hip

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• must be recruited within the first 2 to 3 therapy visits
• have a diagnosis of chronic mechanical low back pain
• 18-65

Exclusion Criteria

• no current neurologic signs or symptoms
• no previous spinal surgery
• no corticosteroid treatment within the last two weeks
• may not be pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

Barton Bishop, DPT

Role: PRINCIPAL_INVESTIGATOR

Sport & Spine Rehab Clinical Research Foundation

Locations

Sport & Spine Rehab

Rockville, Maryland, United States

Countries

United States

Other Identifiers

SSR03

Identifier Type: -

Identifier Source: org_study_id