Low Back PainBENDNCT02308189
The Back Exercises to Neutralize Disability Study
A study testing Exercise with blood flow restriction and Exercise in people with Low Back Pain, run by Ohio University at 1 site in United States.
Trial summary
A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and endurance, whole body and regional lean mass and bone density, as well as the rate of recurrence of LBP (secondary outcomes). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise with blood flow restriction and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 24 May 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women aged 18 to 50 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
- Answer yes to the following question: Have you had two or more episodes of low back pain in the past 12-months with at least one of the episodes causing a restriction of work or leisure time activity?
- Exhibit low trunk extensor endurance defined as the time to task failure during the modified-Sorenson test of less than 176 seconds.
- Body mass index (BMI) between 19 and 37 kg/m2 inclusive.
- With no condition that could limit participation in supervised resistance training exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) (i.e., if a study participant answers yes to questions 1-4 they will be excluded, if they answer yes to 5-7 they will require clearance for participation by the study physician).
- Sedentary lifestyle defined by a classification of "low" or "moderate" levels of physical activity based on the scoring criteria for the International Physical Activity Questionnaire (IPAQ).
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- Willing to maintain current diet and adhere to exercise programs described for the study and to not start any new dieting/weight management programs.
- Willing and able to return for all clinic visits and complete all study-related procedures.
- Able to read, understand, and complete study-related questionnaires
- Able to read and understand, and willing to sign the informed consent form (ICF).
Who cannot join
- Participation in progressive resistance exercise within the previous 24 weeks prior to screening.
- Participation in any clinical trial within 24 weeks prior to screening.
- Hospitalization (medical confinement for ≥24 hours), or immobilization, or major surgical procedure requiring general anesthesia within 24 weeks prior to screening, or any planned surgical procedures during the study period.
- Limb amputation (except for toes) and/or any fracture within 24 weeks.
- Osteoarthritis, rheumatologic diseases or orthopedic disorders which will not allow completion of the motions required for the resistance exercise.
- Conditions (such as myasthenia gravis, myositis, muscular dystrophy or myopathy, including drug-induced myopathy) leading to muscle loss, muscle weakness, muscle cramps or myalgia.
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- Chronic or relapsing/remitting gastrointestinal disorders such as inflammatory bowel diseases, irritable bowel syndrome or gastrointestinal infections within 28 days of screening.
- Acute viral or bacterial upper or lower respiratory infection at screening
- Moderate or severe chronic obstructive pulmonary disease.
- Back pain greater than 4 (on a 10 point numeric pain rating scale) at screening
- Leg length discrepancy > 3 cm.
- Current or recent (i.e., within 12 weeks) of narcotics or muscle relaxants.
- Currently pregnant (confirmed via a urine test) or planning to become pregnant within the next year at screening.
- Report unexplained weight loss over the past 30 days (> 10 pounds).
- Report having pending litigation related to low back pain or currently receiving disability for low back pain.
- Report having received treatment for low back pain from a health care practitioner in the past 6 weeks.
- History of spine surgery or hip arthroplasty.
- Cancer requiring treatment currently or in the past 3 years (except primary non-melanoma skin cancer or in situ cervical cancer)
- Moderate or severe asthma with current or recurring symptoms within the last 1-year.
- Known history of human immunodeficiency virus (HIV) antibody and/or positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis C antibody (HCV) at screening.
- Neurological conditions resulting in impaired muscle function or mobility (e.g., stroke with residual paresis, paralysis, multiple sclerosis, or Parkinson Disease).
- Psychiatric conditions that warrant acute or chronic therapeutic intervention (e.g., major depressive disorder, bipolar disorder, panic disorder, schizophrenia) that in the investigators opinion may interfere with the conduct of study procedures
- History of cardiac conditions such as heart failure (NYHA class II-IV), angina (including unstable angina), myocardial infarction, cardiomyopathy, any cardiac arrhythmia (except stable sinus dysrhythmia or atrial fibrillation) or valvular heart disease (except asymptomatic mitral valve prolapse).
- History of peripheral vascular disease.
- Subjects with the following abnormal ECG findings at screening will be excluded:
- Electrocardiogram findings indicative of left ventricular hypertrophy (LVH) (based on Cornell voltage criteria): For men: S in V3 plus R in a VL >2.8 mV (28 mm) For women: S in V3 plus R in a VL >2.0 mV (20 mm) Electrocardiogram finding of QT prolongation defined as QTcF > 470 ms
- Diabetics using insulin are excluded.
- Abnormal or uncontrolled blood pressure at the screening visit defined as diastolic BP >100 and/or systolic BP >160 mm Hg; if taking anti-hypertensive medication, have to be on stable doses of medication for more than 3 months.
- Current or recent history (within 1 year of screen) of heavy alcohol consumption (males ≥ 21 drinks/week, 4 drinks/day; females ≥ 14 drinks/week, 3 drinks/day) or drug abuse.
- Current or previous use of any drugs known to influence muscle mass or performance within 24 weeks. These may include, but are not limited to, anabolic steroids, IGF-1, growth hormone (GH), replacement androgen therapy, anti-androgen therapy.
- Use of systemic glucocorticoids within 12 weeks prior to screening.
- Having body dimensions that exceed the MRI or exercise equipment limits.
- Unable to undergo MRI (e. g. body containing any metallic medical devices or equipment, including heart pacemakers, metal prostheses, implants or surgical clips, any prior injury from shrapnel or grinding metal, exposure to metallic dusts, metallic shavings or having tattoos containing metallic dyes).
- Unable to reliably undergo exercise or strength tests described for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio Musculoskeletal and Neurological Institute (OMNI) at Ohio University
Athens, Ohio, 45701
About this study
Official title: Novel Exercise Interventions to Improve Trunk Muscle Function: A Pilot Study
A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and endurance, whole body and regional lean mass and bone density, as well as the rate of recurrence of LBP (secondary outcomes).
Read the detailed description
This is a single-blinded, comparison-control group, single-center study of the effects of exercise with and without blood flow restriction applied to the appendicular limbs on safety, body composition (i.e., muscle mass), muscle strength, muscle endurance, whole body and regional lean mass and bone density, and back pain and disability in male and female subjects aged 18-50 years with recurrent low back pain and poor to moderate trunk extensor muscle endurance.
Up to 50 subjects (2 arms) will be randomized in a 1:1 ratio to receive 10-weeks of resistance exercise training with (group 1) or without blood flow restriction (group 2). Randomization will be stratified by sex.
This study will have a screening period of 21 days (day -21 to day -1, screening and baseline measures), a 10-week exercise treatment period (day 1 to day 70) and a 36-week follow up period after the last exercise session (day 70 to day 322). The total duration of the study from first exercise session will be approximately 46 weeks. Baseline measures for muscle size (via MRI), muscle strength, muscle endurance, whole body and regional lean mass and bone density (via DEXA), and measures of back pain and disability will be obtained between day -21 to -1.
Primary Endpoint: The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
Secondary: The secondary endpoints include:
- Muscle strength
- Muscle endurance (time to task failure)
- Whole body and regional lean mass by DEXA
- Whole body and regional bone density by DEXA
- Pain
- Disability
- Safety
- Treatment acceptability Procedures and Assessments Efficacy measures (MRI, muscle strength, muscle endurance, lean mass, bone density, pain, and disability) will be obtained at screening and at week 10 (day 70) and week 20 (day 154).
Safety of blood flow restricted exercise will be assessed based on adverse event findings and monitoring. Subjects will be asked to monitor and report all adverse events (AEs) experienced from the time the informed consent is signed until the end-of-study visit.
Treatment acceptability will be determined by administering the Treatment Evaluation Inventory survey at the end of the fourth and sixteenth exercise sessions.
- Conditions
- Low Back Pain
- Being tested
- Exercise with blood flow restriction, Exercise
- Keywords
- Exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with blood flow restrictionBehavioural
Also called Kaatsu Training with Blood Flow Restricted Exercise
Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
ExerciseBehavioural
Also called Resistance exercise
Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Low load resistance exercise training Receives: Behavioral: Exercise |
| Exercise with blood flow restriction | Experimental | Low load resistance exercise training with blood flow restriction Receives: Behavioral: Exercise with blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Extensor Muscle Cross Sectional Area % of Change
The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
Measured: Baseline and following 10-weeks of exercise training. Values are calculated from % change.
Secondary outcomes (2)
Muscle Strength % of Change
Maximal muscle strength
Measured: Baseline and following 10-weeks of exercise training. Values calculated are % of change
Muscle Endurance (Time to Task Failure) % of Change
Time for successfully performing a sustained, submaximal muscle contraction
Measured: Baseline and following 10-weeks of exercise training. Values are calculated on % of change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion24 Nov 2016
- Study completion24 May 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Brian C Clark, PhD, Principal investigator, Ohio Musculoskeletal and Neurological Institute (OMNI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308189
- Sponsor's protocol ID
- 14F025
- Other IDs
- 1R21AR063909
- Acronym
- BEND
- Status last verified
- May 2018
- First submitted
- 2 Dec 2014
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.
PubMed 26867541
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Exercise Interventions to Improve Trunk Muscle Function: A Pilot Study
- ClinicalTrials.gov ID
- NCT02308189
- Acronym / sponsor ID
- BEND / 14F025
- Conditions
- Low Back Pain
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2014
- Primary completion
- 24 Nov 2016 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot randomized control trial (RCT) to generate effect sizes on the effects of blood flow restricted exercise on trunk extensor cross-sectional area (primary outcome), strength and endurance, whole body and regional lean mass and bone density, as well as the rate of recurrence of LBP (secondary outcomes).
Detailed description
This is a single-blinded, comparison-control group, single-center study of the effects of exercise with and without blood flow restriction applied to the appendicular limbs on safety, body composition (i.e., muscle mass), muscle strength, muscle endurance, whole body and regional lean mass and bone density, and back pain and disability in male and female subjects aged 18-50 years with recurrent low back pain and poor to moderate trunk extensor muscle endurance.
Up to 50 subjects (2 arms) will be randomized in a 1:1 ratio to receive 10-weeks of resistance exercise training with (group 1) or without blood flow restriction (group 2). Randomization will be stratified by sex.
This study will have a screening period of 21 days (day -21 to day -1, screening and baseline measures), a 10-week exercise treatment period (day 1 to day 70) and a 36-week follow up period after the last exercise session (day 70 to day 322). The total duration of the study from first exercise session will be approximately 46 weeks. Baseline measures for muscle size (via MRI), muscle strength, muscle endurance, whole body and regional lean mass and bone density (via DEXA), and measures of back pain and disability will be obtained between day -21 to -1.
Primary Endpoint: The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
Secondary: The secondary endpoints include:
- Muscle strength
- Muscle endurance (time to task failure)
- Whole body and regional lean mass by DEXA
- Whole body and regional bone density by DEXA
- Pain
- Disability
- Safety
- Treatment acceptability Procedures and Assessments Efficacy measures (MRI, muscle strength, muscle endurance, lean mass, bone density, pain, and disability) will be obtained at screening and at week 10 (day 70) and week 20 (day 154).
Safety of blood flow restricted exercise will be assessed based on adverse event findings and monitoring. Subjects will be asked to monitor and report all adverse events (AEs) experienced from the time the informed consent is signed until the end-of-study visit.
Treatment acceptability will be determined by administering the Treatment Evaluation Inventory survey at the end of the fourth and sixteenth exercise sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: ExerciseLow load resistance exercise training |
| Exercise with blood flow restriction | Experimental | Behavioral: Exercise with blood flow restrictionLow load resistance exercise training with blood flow restriction |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Men and women aged 18 to 50 years, with no significant health issues or conditions that, in the investigator's opinion, would limit the subject's ability to complete the study per protocol or that would impact the capability to get an accurate measurement of study endpoints.
- Answer yes to the following question: Have you had two or more episodes of low back pain in the past 12-months with at least one of the episodes causing a restriction of work or leisure time activity?
- Exhibit low trunk extensor endurance defined as the time to task failure during the modified-Sorenson test of less than 176 seconds.
- Body mass index (BMI) between 19 and 37 kg/m2 inclusive.
- With no condition that could limit participation in supervised resistance training exercise based on the Physical Activity Readiness Questionnaire (PAR-Q) (i.e., if a study participant answers yes to questions 1-4 they will be excluded, if they answer yes to 5-7 they will require clearance for participation by the study physician).
Key exclusion criteria (34 listed)
- Participation in progressive resistance exercise within the previous 24 weeks prior to screening.
- Participation in any clinical trial within 24 weeks prior to screening.
- Hospitalization (medical confinement for ≥24 hours), or immobilization, or major surgical procedure requiring general anesthesia within 24 weeks prior to screening, or any planned surgical procedures during the study period.
- Limb amputation (except for toes) and/or any fracture within 24 weeks.
- Osteoarthritis, rheumatologic diseases or orthopedic disorders which will not allow completion of the motions required for the resistance exercise.
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 |
|---|---|---|
| Exercise with blood flow restrictionAlso: Kaatsu Training with Blood Flow Restricted ExerciseLow load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises. | Behavioural | Exercise with blood flow restriction |
| ExerciseAlso: Resistance exerciseLow load resistance exercise performed with no external pressure cuff applied to the appendicular limbs. | Behavioural | Exercise |
Primary outcome
Trunk Extensor Muscle Cross Sectional Area % of Change
Time frame: Baseline and following 10-weeks of exercise training. Values are calculated from % change.
The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.
2 secondary outcomes
Muscle Strength % of Change
Time frame: Baseline and following 10-weeks of exercise training. Values calculated are % of change
Muscle Endurance (Time to Task Failure) % of Change
Time frame: Baseline and following 10-weeks of exercise training. Values are calculated on % of change.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26867541Amano S, Ludin AF, Clift R, Nakazawa M, Law TD, Rush LJ, Manini TM, Thomas JS, Russ DW, Clark BC. Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 12;17:81. doi: 10.1186/s13063-016-1214-7.
- Individual participant dataSharing planned: No
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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.
Brian C Clark, PhD principal investigator
Ohio Musculoskeletal and Neurological Institute (OMNI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with blood flow restriction and Exercise in people with Low Back Pain, run by Ohio University 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 10 inclusion and 34 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 19 Jun 2018. 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 19 Jun 2018). 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?
Trunk Extensor Muscle Cross Sectional Area % of Change (time frame: Baseline and following 10-weeks of exercise training. Values are calculated from % change.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308189, which also lists 1 linked publication.
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 19 Jun 2018.