Cramer Sports Motion Tape and Low Back Pain EMG (KT_LBP_EMG)

Effectiveness of Cramer Sports Motion Tape on Low Back Pain Patients' Pain and Muscle Activation

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Cramer Sports Motion Tape

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Sport & Spine Rehab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Back Pain; Lower body exercises before and after the application of Cramer Sports Motion tape	Device: Cramer Sports Motion Tape; lower body exercises with and without Cramer Sports Motion tape applied to the hip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Maximal Voluntary Isometric Contraction (%MVIC)	3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.	% Maximal Voluntary Isometric Contracion (%MVIC)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Exertion	The amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.	Perceived Exertion

Collaborators and Investigators

• Sponsor: Sport and Spine Rehab Clinical Research Foundation
• Investigators: Principal Investigator: Barton Bishop, DPT, Sport & Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 21, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: EMG; Thera-Band; Gluteus Medius; TFL; kinesiology tape; Gluteus Maximum; Flexion-Response Phenomenon
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: SSR03