Low Back PainNCT01342432
Impact of a Balance Reeducation Protocol on Pain, Function and Postural Control of Low Back Pain Patients
A study testing General exercise only and Balance reeducation plus general exercise in people with Low Back Pain, run by Centro Universitari Fieo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- General exercise only and Balance reeducation plus general exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Oct 2009
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have low back pain longer than three months and age between 40 and 69 years old
Who cannot join
- balance or neuromuscular disorders, spine surgery, diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients
The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.
Read the detailed description
Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.
- Conditions
- Low Back Pain
- Being tested
- General exercise only, Balance reeducation plus general exercise
- Keywords
- low back pain, balance reeducation, pain, function
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General exercise onlyOther
Also called control group
exercises for stretch and strength of paraspinal and abdominal muscles
Balance reeducation plus general exerciseOther
Also called balance group, intervention group
patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
| Study group | Role | What they receive |
|---|---|---|
| Balance reeducation plus exercise | Experimental | exercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles Receives: Other: Balance reeducation plus general exercise |
| General exercise only | Other | general exercise for stretch and strength of paraspinal and abdominal muscles Receives: Other: General exercise only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain
Pain was measured by an Analogic Visual Scale
Measured: 5 weeks
Secondary outcomes (2)
Function
Function was measured by the Roland-Morris Questionnaire
Measured: 5 weeks
Postural Control
Postural control was measured by Functional Reach Test and by posturography
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startJan 2009
- Primary completionJun 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitari Fieo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Investigators
- Thais Bojadsen, PhD, Principal investigator, Centro Universitario Fieo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342432
- Sponsor's protocol ID
- 2008/069241
- Other IDs
- 2008
- Status last verified
- Dec 2009
- First submitted
- 4 Apr 2011
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balance Reeducation Plus General Exercises Versus General Exercises Only: Impact on Pain, Function and Postural Control of Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT01342432
- Acronym / sponsor ID
- 2008/069241
- Conditions
- Low Back Pain
- Keywords
- low back pain, balance reeducation, pain, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centro Universitari FieoUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Apr 2011 (estimated)
- 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.
The purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.
Detailed description
Both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. The evolution of the two groups concerning pain level, function and postural control will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance reeducation plus exercise | Experimental | Other: Balance reeducation plus general exerciseexercises that challenge postural control are performed in addition to general exercises for stretch and strength of abdominal and paraspinal muscles |
| General exercise only | Other | Other: General exercise onlygeneral exercise for stretch and strength of paraspinal and abdominal muscles |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must have low back pain longer than three months and age between 40 and 69 years old
Key exclusion criteria (1 listed)
- balance or neuromuscular disorders, spine surgery, diabetes.
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 |
|---|---|---|
| General exercise onlyAlso: control groupexercises for stretch and strength of paraspinal and abdominal muscles | Other | General exercise only |
| Balance reeducation plus general exerciseAlso: balance group, intervention grouppatients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles | Other | Balance reeducation plus exercise |
Primary outcome
Perceived pain
Time frame: 5 weeks
Pain was measured by an Analogic Visual Scale
2 secondary outcomes
Function
Time frame: 5 weeks
Postural Control
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
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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.
Thais Bojadsen, PhD principal investigator
Centro Universitario Fieo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General exercise only and Balance reeducation plus general exercise in people with Low Back Pain, run by Centro Universitari Fieo 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: finished, as of the sponsor's last update on 27 Apr 2011. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived pain (time frame: 5 weeks). 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 27 Apr 2011.