Chronic Low Back PainPhase 4NCT02062918
Abdominal Belt Use to Treat Low Back Pain
A Phase 4 study testing Abdominal belt in people with Chronic Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain. Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Abdominal belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Feb 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients from both genders,
- between 18 and 65 years of age,
- who sought medical care for a complaint of lumbar pain,
- diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
- who agreed to participate in the study and signed terms of informed consent.
Who cannot join
- diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
- fibromyalgia,
- previous spinal surgery,
- litigation (patients on leave from work or in work leave processes due to low back pain);
- having changed physical activity in previous three months;
- body mass index (BMI) higher than 30;
- acupuncture treatment or physiotherapy in the previous three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment
Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.
Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.
Hypothesis - abdominal belt will improve pain in chronic low back pain patients
- Conditions
- Chronic Low Back Pain
- Being tested
- Abdominal belt
- Keywords
- Abdominal belt, Chronic low back pain, Pain, Functional capacity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal beltDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in the control group did not use an abdominal belt. |
| Experimental group | Experimental | Patients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose. Receives: Device: Abdominal belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain using VAS
Measured: Baseline, after 1,3, and 6 months
Secondary outcomes (3)
Change in functional capacity (Roland-Morris questionnaire)
Measured: Baseline, after 1,3 and 6 months
Change in hours of abdominal belt use
Measured: Baseline, after 1,3 and 6 months
Change in patient satisfaction with treatment using VAS
Measured: Baseline, after 1,3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Jamil Natour, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062918
- Sponsor's protocol ID
- CEP?UNIFESP-1726/10
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Abdominal Belt for the Chronic Low Back Pain Treatment
- ClinicalTrials.gov ID
- NCT02062918
- Acronym / sponsor ID
- CEP?UNIFESP-1726/10
- Conditions
- Chronic Low Back Pain
- Keywords
- Abdominal belt, Chronic low back pain, Pain, Functional capacity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Feb 2014 (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.
Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.
Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.
Hypothesis - abdominal belt will improve pain in chronic low back pain patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in the control group did not use an abdominal belt. |
| Experimental group | Experimental | Device: Abdominal beltPatients were instructed in how to use the abdominal belt for activities of physical effort that exacerbated lumbar pain as well as during moments of pain, and not to use it during rest. They should record the number of hours of belt use per day on spreadsheets distributed for this purpose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients from both genders,
- between 18 and 65 years of age,
- who sought medical care for a complaint of lumbar pain,
- diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
- who agreed to participate in the study and signed terms of informed consent.
Key exclusion criteria (7 listed)
- diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
- fibromyalgia,
- previous spinal surgery,
- litigation (patients on leave from work or in work leave processes due to low back pain);
- having changed physical activity in previous three months;
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 |
|---|---|---|
| Abdominal belt | Device | Experimental group |
Primary outcome
Change in pain using VAS
Time frame: Baseline, after 1,3, and 6 months
3 secondary outcomes
Change in functional capacity (Roland-Morris questionnaire)
Time frame: Baseline, after 1,3 and 6 months
Change in hours of abdominal belt use
Time frame: Baseline, after 1,3 and 6 months
Change in patient satisfaction with treatment using VAS
Time frame: Baseline, after 1,3 and 6 months
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 14 Feb 2014.
Related trials for Chronic 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.
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 Phase 4 study testing Abdominal belt in people with Chronic Low Back Pain, run by Federal University of São Paulo 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 5 inclusion and 7 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 14 Feb 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain using VAS (time frame: Baseline, after 1,3, and 6 months). 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 14 Feb 2014.