Low Back PainGlutEMG02NCT01841216
EMG Activation of Gluteal Musculature During Exercises With and Without Resistance
A study testing Lower Body Exercises with and without resistance in people with Low Back Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial summary
The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lower Body Exercises with and without resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, physically active subjects
- patients diagnosed with non-radicular low back pain
- 18-65
Who cannot join
- current low back or lower extremity injury (healthy group)
- pregnancy
- history of hip surgery
- radicular symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMG Activation of Gluteal Musculature and Perceived Exertion During Therapeutic Exercises With and Without Thera-Band® Resistance
The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy and low back pain patients while performing exercises with and without resistance. Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular low back pain will be recruited. Exclusionary criteria will include: current low back or lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms. Surface electromyography will be used to quantify the activity level of the gluteal muscles and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be established for each muscle group and the order of exercises performed will be randomized to minimize the effect of fatigue. Following the completion of each exercise, the patient will rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a root-mean-square algorithm. Clinical Relevance: The results of this study will allow clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit the TFL involvement, in the treatment of low back pain.
- Conditions
- Low Back Pain
- Being tested
- Lower Body Exercises with and without resistance
- Keywords
- Gluteus Maximus, Gluteus Medius, TFL, EMG, Perceived Exertion, Thera-Band
- 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.
Lower Body Exercises with and without resistanceDevice
lower body exercises with and without resistance designed to activate the gluteal/hip musculature
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain | Experimental | Lower Body Exercises with and without resistance Receives: Device: Lower Body Exercises with and without resistance |
| Healthy | Experimental | Lower Body Exercises with and without resistance Receives: Device: Lower Body Exercises with and without resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.
Measured: One 40 minute session
Secondary outcomes (1)
Perceived Exertion
Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.
Measured: 16 exercises during one 40 minute session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01841216
- Sponsor's protocol ID
- SSR02
- Acronym
- GlutEMG02
- Status last verified
- Jan 2015
- First submitted
- 23 Apr 2013
- Last updated
- 3 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG Activation of Gluteal Musculature and Perceived Exertion During Therapeutic Exercises With and Without Thera-Band® Resistance
- ClinicalTrials.gov ID
- NCT01841216
- Acronym / sponsor ID
- GlutEMG02 / SSR02
- Conditions
- Low Back Pain
- Keywords
- Gluteus Maximus, Gluteus Medius, TFL, EMG, Perceived Exertion, Thera-Band
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Posted 3 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy and low back pain patients while performing exercises with and without resistance. Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular low back pain will be recruited. Exclusionary criteria will include: current low back or lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms. Surface electromyography will be used to quantify the activity level of the gluteal muscles and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be established for each muscle group and the order of exercises performed will be randomized to minimize the effect of fatigue. Following the completion of each exercise, the patient will rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a root-mean-square algorithm. Clinical Relevance: The results of this study will allow clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit the TFL involvement, in the treatment of low back pain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain | Experimental | Device: Lower Body Exercises with and without resistanceLower Body Exercises with and without resistance |
| Healthy | Experimental | Device: Lower Body Exercises with and without resistanceLower Body Exercises with and without resistance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy, physically active subjects
- patients diagnosed with non-radicular low back pain
- 18-65
Key exclusion criteria (4 listed)
- current low back or lower extremity injury (healthy group)
- pregnancy
- history of hip surgery
- radicular symptoms
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 |
|---|---|---|
| Lower Body Exercises with and without resistancelower body exercises with and without resistance designed to activate the gluteal/hip musculature | Device | Healthy, Low Back Pain |
Primary outcome
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Time frame: One 40 minute session
Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.
1 secondary outcome
Perceived Exertion
Time frame: 16 exercises during one 40 minute session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Lower Body Exercises with and without resistance 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 3 Feb 2015. 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 3 Feb 2015). 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: One 40 minute session). 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 3 Feb 2015.