Low Back PainKT_LBP_EMGNCT02122445
Cramer Sports Motion Tape and Low Back Pain EMG
A study testing Cramer Sports Motion Tape in people with Low Back Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Cramer Sports Motion Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be recruited within the first 2 to 3 therapy visits
- have a diagnosis of chronic mechanical low back pain
- 18-65
Who cannot join
- no current neurologic signs or symptoms
- no previous spinal surgery
- no corticosteroid treatment within the last two weeks
- may not be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Cramer Sports Motion Tape
- Keywords
- Gluteus Maximum, Gluteus Medius, TFL, EMG, Flexion-Response Phenomenon, Thera-Band, kinesiology tape
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cramer Sports Motion TapeDevice
lower body exercises with and without Cramer Sports Motion tape applied to the hip
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain | Experimental | Lower body exercises before and after the application of Cramer Sports Motion tape Receives: Device: Cramer Sports Motion Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: % Maximal Voluntary Isometric Contracion (%MVIC)
Secondary outcomes (1)
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.
Measured: Perceived Exertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barton Bishop, DPT, Principal investigator, Sport & Spine Rehab Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122445
- Sponsor's protocol ID
- SSR03
- Acronym
- KT_LBP_EMG
- Status last verified
- Jan 2016
- First submitted
- 21 Apr 2014
- Last updated
- 9 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cramer Sports Motion Tape on Low Back Pain Patients' Pain and Muscle Activation
- ClinicalTrials.gov ID
- NCT02122445
- Acronym / sponsor ID
- KT_LBP_EMG / SSR03
- Conditions
- Low Back Pain
- Keywords
- Gluteus Maximum, Gluteus Medius, TFL, EMG, Flexion-Response Phenomenon, Thera-Band, kinesiology tape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | Experimental | Device: Cramer Sports Motion TapeLower body exercises before and after the application of Cramer Sports Motion tape |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must be recruited within the first 2 to 3 therapy visits
- have a diagnosis of chronic mechanical low back pain
- 18-65
Key exclusion criteria (4 listed)
- no current neurologic signs or symptoms
- no previous spinal surgery
- no corticosteroid treatment within the last two weeks
- may not be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cramer Sports Motion Tapelower body exercises with and without Cramer Sports Motion tape applied to the hip | Device | Low Back Pain |
Primary outcome
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Time frame: % Maximal Voluntary Isometric Contracion (%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.
1 secondary outcome
Perceived Exertion
Time frame: Perceived Exertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barton Bishop, DPT principal investigator
Sport & Spine Rehab Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cramer Sports Motion Tape in people with Low Back Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Maximal Voluntary Isometric Contraction (%MVIC) (time frame: % Maximal Voluntary Isometric Contracion (%MVIC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.