Clinical trial NCT02122445: Cramer Sports Motion Tape and Low Back Pain EMG
Official title: Effectiveness of Cramer Sports Motion Tape on Low Back Pain Patients' Pain and Muscle Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Gluteus Maximum
Gluteus Medius
TFL
EMG
Flexion-Response Phenomenon
Thera-Band
kinesiology tape
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of Maximal Voluntary Isometric Contraction (%MVIC)
timeFrame: % Maximal Voluntary Isometric Contracion (%MVIC)
Secondary outcomes:
measure: Perceived Exertion
timeFrame: Perceived Exertion
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport & Spine Rehab
state: Maryland
Study officials:
affiliation: Sport & Spine Rehab Clinical Research Foundation
name: Barton Bishop, DPT
role: PRINCIPAL_INVESTIGATOR
References: