Lumbar PainNCT02815358
Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
A study testing Segmental Stabilization Exercises and Home Exercises in people with Lumbar Pain, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lumbar Pain
- What is being tested?
- Segmental Stabilization Exercises and Home Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Nov 2016
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged between 18 and 65 years old
- chronic lumbar pain (at least 3 months)
- average pain intensity of ≥3 on a 10-point scale
Who cannot join
- presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
- history of back surgery
- pregnancy
- less than 3 months of therapeutic treatment (physiotherapy) for low back pain
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder flexion/extension.
- Conditions
- Lumbar Pain
- Being tested
- Segmental Stabilization Exercises, Home Exercises
- 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.
Segmental Stabilization ExercisesOther
The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.
Home ExercisesOther
Home exercises include passive stretching and active mobilization of the spine.
| Study group | Role | What they receive |
|---|---|---|
| Segmental Stabilization Group | Experimental | Patients receiving segmental stabilization exercises. Receives: Other: Segmental Stabilization Exercises |
| Control Group | Active comparator | Patients receiving home exercises. Receives: Other: Home Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipatory Postural Adjustment by means of Electromyography
Assessed by means of superficial electromyography
Measured: change from pre to post-treatment (8 weeks)
Secondary outcomes (4)
Disability level via the Oswestry Low Back Pain Questionnaire
Measured: change from pre to post-treatment (8 weeks)
Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
Measured: change from pre to post-treatment (8 weeks)
Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
Measured: change from pre to post-treatment (8 weeks)
Pain level via visual analogue scale
Measured: change from pre to post-treatment (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815358
- Sponsor's protocol ID
- 923.642
- Status last verified
- Jun 2019
- First submitted
- 22 Jun 2016
- Last updated
- 13 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Segmental Stabilization on the Anticipatory Postural Adjustment of Subjects With Lumbar Pain
- ClinicalTrials.gov ID
- NCT02815358
- Acronym / sponsor ID
- 923.642
- Conditions
- Lumbar Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Jun 2016 (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.
This study aims to verify the effects of a segmental stabilization exercise program on the anticipatory postural adjustment of subjects with chronic lumbar pain. The effects will be assessed by means of superficial electromyography focused on the registry of the onset of multifidius and deltoid (anterior and posterior) activity during a repetitive shoulder flexion/extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmental Stabilization Group | Experimental | Other: Segmental Stabilization ExercisesPatients receiving segmental stabilization exercises. |
| Control Group | Active comparator | Other: Home ExercisesPatients receiving home exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women aged between 18 and 65 years old
- chronic lumbar pain (at least 3 months)
- average pain intensity of ≥3 on a 10-point scale
Key exclusion criteria (4 listed)
- presence of red flags (i.e.,tumor, known fractures, diagnosed inflammatory joint disease, etc);
- history of back surgery
- pregnancy
- less than 3 months of therapeutic treatment (physiotherapy) for low back pain
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 |
|---|---|---|
| Segmental Stabilization ExercisesThe stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures. | Other | Segmental Stabilization Group |
| Home ExercisesHome exercises include passive stretching and active mobilization of the spine. | Other | Control Group |
Primary outcome
Anticipatory Postural Adjustment by means of Electromyography
Time frame: change from pre to post-treatment (8 weeks)
Assessed by means of superficial electromyography
4 secondary outcomes
Disability level via the Oswestry Low Back Pain Questionnaire
Time frame: change from pre to post-treatment (8 weeks)
Fear of pain and avoidance of physical activity via the Fear-avoidance beliefs Questionnaire
Time frame: change from pre to post-treatment (8 weeks)
Prognosis or risk of poor clinical outcome via the STarT Back Screening Tool
Time frame: change from pre to post-treatment (8 weeks)
Pain level via visual analogue scale
Time frame: change from pre to post-treatment (8 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 13 Jun 2019.
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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 Segmental Stabilization Exercises and Home Exercises in people with Lumbar Pain, run by Federal University of Health Science of Porto Alegre 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 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 13 Jun 2019. 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?
Anticipatory Postural Adjustment by means of Electromyography (time frame: change from pre to post-treatment (8 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 13 Jun 2019.