Low Back PainNCT03424278
Efficacy of Exercises in Individuals With Non-specific Chronic Low Back Pain
A study testing Resistance training exercises in people with Low Back Pain, run by University of Brasilia at 1 site in Brazil.
Trial summary
This is a randomized controlled trial project to analyze the effectiveness of lumbar motor control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk strength in individual with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Resistance training exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Feb 2017to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonspecific chronic low back pain (defined as pain and discomfort) localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain of at least 3 months' duration.
Who cannot join
- Spinal pathology (eg, tumor, infection, fracture, inflammatory disease), pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, and presence of any contraindication to exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Motor Control Exercises and Resistance Training on Pain, Function, Kinesiophobia and Trunk Strength in Individuals With Non-specific Chronic Low Back Pain
This is a randomized controlled trial project to analyze the effectiveness of lumbar motor control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk strength in individual with chronic low back pain. The project has two parallel arms and will be supervised by physiotherapists (motor control exercises) and physical education professionals (resistance training). The participants will be Militaries of the Military Fire Department of the Federal District who presents in the recruitment regular low back pain more than 3 months. The two groups will be supervised in12 weeks of exercises in the Physical Activity Center of Military Fire Department of the Federal District. Our hypotheses is that the resistance training effects wil be superior to motor control exercises only for trunk strength (isokinetic flexion and extension).
- Conditions
- Low Back Pain
- Being tested
- Motor control exercises, Resistance training exercises
- Keywords
- Low back pain, 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.
Motor control exercisesOther
Motor control exercises for the deep trunk muscles in patients with chronic low back pain is based on evidence of motor control dysfunction, including delayed onset of activity in the transversus abdomens and internal oblique abdominal muscles and segmental hypertrophy of the lumbar multifidus muscle.
Resistance training exercisesOther
A type of strength-building exercise program that requires the body muscle to exert a force against some form of resistance, such as weight, stretch bands, water, or immovable objects. Resistance exercise is a combination of static and dynamic contractions involving shortening and lengthening of skeletal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control | Active comparator | Not described Receives: Other: Motor control exercises |
| Resistance Training | Experimental | Not described Receives: Other: Resistance training exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Measured: One day
Roland-Morris Disability Questionnaire (RDQ)
Questionnaires to measure and monitor changes in functional outcome in patients with LBP. The RDQ evaluates 24 activity limitations due to LBP, while the ODI consists of 10 items assessing the level of pain interference with physical activities.
Measured: One day
Tampa Scale for Kinesiophobia (TSK)
Measures the excessive, irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.
Measured: One day
Secondary outcomes (1)
Trunk Muscle strength
This outcome will be assessed by a isokinetic dynamometer. Today dynamometry routinely assesses muscle performance in healthy and symptomatic populations.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start10 Feb 2017
- Primary completion10 Feb 2017
- Study completion10 Nov 2017 (estimated)
Why it stopped: The participants recruitment was to difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Model description
- Parallel randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Collaborators
- Military Fire Department of the Federal District
- Responsible party
- Principal investigator, Wagner Rodrigues Martins, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424278
- Sponsor's protocol ID
- PPGCR1
- Status last verified
- Jan 2021
- First submitted
- 31 Jan 2018
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saragiotto BT, Maher CG, Yamato TP, Costa LOP, Costa LCM, Ostelo RWJG, Macedo LG. Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review. Spine (Phila Pa 1976). 2016 Aug 15;41(16):1284-1295. doi: 10.1097/BRS.0000000000001645.
PubMed 27128390Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
PubMed 26742533Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
PubMed 23492976Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015 Mar;27(3):619-22. doi: 10.1589/jpts.27.619. Epub 2015 Mar 31.
PubMed 25931693Steele J, Bruce-Low S, Smith D. A review of the clinical value of isolated lumbar extension resistance training for chronic low back pain. PM R. 2015 Feb;7(2):169-87. doi: 10.1016/j.pmrj.2014.10.009. Epub 2014 Oct 29.
PubMed 25452128Kristensen J, Franklyn-Miller A. Resistance training in musculoskeletal rehabilitation: a systematic review. Br J Sports Med. 2012 Aug;46(10):719-26. doi: 10.1136/bjsm.2010.079376. Epub 2011 Jul 26.
PubMed 21791457
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Motor Control Exercises and Resistance Training on Pain, Function, Kinesiophobia and Trunk Strength in Individuals With Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03424278
- Acronym / sponsor ID
- PPGCR1
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The participants recruitment was to difficult
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Collaborators
- Military Fire Department of the Federal District
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 10 Nov 2017 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial project to analyze the effectiveness of lumbar motor control exercises and lumbar resistance training on pain, functional, kinesiophobia and trunk strength in individual with chronic low back pain. The project has two parallel arms and will be supervised by physiotherapists (motor control exercises) and physical education professionals (resistance training). The participants will be Militaries of the Military Fire Department of the Federal District who presents in the recruitment regular low back pain more than 3 months. The two groups will be supervised in12 weeks of exercises in the Physical Activity Center of Military Fire Department of the Federal District. Our hypotheses is that the resistance training effects wil be superior to motor control exercises only for trunk strength (isokinetic flexion and extension).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Motor Control | Active comparator | Other: Motor control exercises |
| Resistance Training | Experimental | Other: Resistance training exercises |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nonspecific chronic low back pain (defined as pain and discomfort) localized below the costal margin and above the inferior gluteal folds, with or without referred leg pain of at least 3 months' duration.
Key exclusion criteria (1 listed)
- Spinal pathology (eg, tumor, infection, fracture, inflammatory disease), pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, and presence of any contraindication to 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 |
|---|---|---|
| Motor control exercisesMotor control exercises for the deep trunk muscles in patients with chronic low back pain is based on evidence of motor control dysfunction, including delayed onset of activity in the transversus abdomens and internal oblique abdominal muscles and segmental hypertrophy of the lumbar multifidus muscle. | Other | Motor Control |
| Resistance training exercisesA type of strength-building exercise program that requires the body muscle to exert a force against some form of resistance, such as weight, stretch bands, water, or immovable objects. Resistance exercise is a combination of static and dynamic contractions involving shortening and lengthening of skeletal muscles. | Other | Resistance Training |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: One day
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Roland-Morris Disability Questionnaire (RDQ)
Time frame: One day
Questionnaires to measure and monitor changes in functional outcome in patients with LBP. The RDQ evaluates 24 activity limitations due to LBP, while the ODI consists of 10 items assessing the level of pain interference with physical activities.
Tampa Scale for Kinesiophobia (TSK)
Time frame: One day
Measures the excessive, irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.
1 secondary outcome
Trunk Muscle strength
Time frame: One day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Background: PubMed 27128390Saragiotto BT, Maher CG, Yamato TP, Costa LOP, Costa LCM, Ostelo RWJG, Macedo LG. Motor Control Exercise for Nonspecific Low Back Pain: A Cochrane Review. Spine (Phila Pa 1976). 2016 Aug 15;41(16):1284-1295. doi: 10.1097/BRS.0000000000001645.
- Background: PubMed 26742533Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
- Background: PubMed 23492976Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
- Background: PubMed 25931693Chang WD, Lin HY, Lai PT. Core strength training for patients with chronic low back pain. J Phys Ther Sci. 2015 Mar;27(3):619-22. doi: 10.1589/jpts.27.619. Epub 2015 Mar 31.
- Background: PubMed 25452128Steele J, Bruce-Low S, Smith D. A review of the clinical value of isolated lumbar extension resistance training for chronic low back pain. PM R. 2015 Feb;7(2):169-87. doi: 10.1016/j.pmrj.2014.10.009. Epub 2014 Oct 29.
- Background: PubMed 21791457Kristensen J, Franklyn-Miller A. Resistance training in musculoskeletal rehabilitation: a systematic review. Br J Sports Med. 2012 Aug;46(10):719-26. doi: 10.1136/bjsm.2010.079376. Epub 2011 Jul 26.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training exercises in people with Low Back Pain, run by University of Brasilia at 1 site in Brazil.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Aug 2023. 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 Brazil. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numerical Rating Scale (NRS) (time frame: One day). The study lists 3 primary outcomes in all. 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 NCT03424278, which also lists 6 linked publications.
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 16 Aug 2023.