Low Back PainNCT02985892
Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain
A study testing SSASG and SSPSG in people with Low Back Pain, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- SSASG and SSPSG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2016to Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals diagnosed with nonspecific chronic low back pain without radicular symptoms for a period exceeding 12 months,
- pain intensity greater than 3/10 points in Numerical Pain Scale
Who cannot join
- patients who have some contraindication to perform exercises according to the American College of Sports Medicine guidelines, such as severe spinal disease (nonunion or malunion, tumors and inflammatory diseases);
- spine surgeries;
- degenerative or inflammatory disorders of the shoulder;
- patients who are in labor dispute; or are doing other types of physical therapy or drug treatment.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Carina Carvalho Correia Coutinho
João Pessoa, Paraíba, 58030-390
Carina Carvalho
João Pessoa, Paraíba, 58051900
About this study
Official title: Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial
The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. However, there is no study that associates these two treatments for nonspecific low back pain. This study will be a controlled clinical trial, randomized, prospective, single-blind with a quantitative approach that compares the efficacy of the association between segmental stabilization + trunk stretching with segmental stabilization + placebo stretching in patients with chronic nonspecific low back pain.
Read the detailed description
BACKGROUND: Chronic nonspecific low back pain (LCI) has a high incidence in the world population and can lead to disability. Several therapeutic approaches have been studied to treat this pathology, but most investigate only the efficacy of one form of treatment per group. Studies show the effect of Segmental Stabilization in patients with LCI, but there is a gap on the effects of the association of trunk stretches with segmental stabilization exercises on pain and disability with LCI. Therefore, the objective of this study is to investigate the effects of the association of trunk stretching and segmental stabilization exercises on chronic non-specific low back pain in the short and medium term.
Method / Design: It will be a controlled, randomized, prospective, blinded clinical trial with quantitative approach, performed at the Clinical School of Physiotherapy of the UFPB. Participants in the study were 34 subjects of both sexes, aged 18 to 80 years, with pain equal to or greater than 3 by the Numerical Pain Scale (0/10) randomized into two groups: Placebo Stretching Group + Segmental Stabilization (n = 17) who will only do exercises of placebo stretching and segmental stabilization; And Segmental Stretching-Stabilization Group (n = 17), submitted to segmental stabilization exercises associated with trunk stretches; Both groups with 12 sessions. The results on pain intensity, functional capacity, overall effect perception, and clinical-psycho-functional assessment, as per the IMMPACT recommendations for clinical trials of effectiveness and efficacy of treatment for chronic pain, will be made by a blind After the intervention, three and six months after randomization.
Discussion: Because of its design, it will be possible to blind the evaluator, the randomizer, and the patient. At the end of the research we hope to contribute to the clinical decision-making process in the choice of therapies that improve pain and disability in patients with non-specific chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- SSASG, SSPSG
- Keywords
- Physical therapy, Muscle Stretching Exercises, Low Back pain
- 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.
SSASGOther
Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval.
Patients of segmental stabilization active stretching group (SSASG) will perform stretch exercises in four sets of 30 seconds for each muscle. The active stretching exercises will last 15 minutes. The muscles that will be stretched are pectorals, latissimus dorsi, latissimus dorsi, teres major, rectus abdominis, external and internal oblique.
SSPSGOther
Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval.
Patients of segmental stabilization placebo stretching group (SSPSG) will perform exercises that simulate stretching, but the muscles will not suffer effective stretch. The placebo stretching exercises will last 15 minutes. The muscles that will be stretched are wrist flexors and extensors muscles and fingers flexors and extensors muscles.
| Study group | Role | What they receive |
|---|---|---|
| SSASG | Experimental | Stabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005. Receives: Other: SSASG |
| SSPSG | Experimental | Stabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005. Receives: Other: SSPSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain through Pain visual analogue scale
Measured: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Secondary outcomes (1)
Global Perceived Effect Scale
Measured: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionDec 2018
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.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Paraíba
- Responsible party
- Sponsor
- Investigators
- Raquel Casarotto, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985892
- Sponsor's protocol ID
- EATSSSE
- Status last verified
- Feb 2019
- First submitted
- 5 Dec 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02985892
- Acronym / sponsor ID
- EATSSSE
- Conditions
- Low Back Pain
- Keywords
- Physical therapy, Muscle Stretching Exercises, Low Back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Federal University of Paraíba
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Dec 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.
The incidence of chronic nonspecific low back pain is the highest in the world population and can lead to disability. One of the standards treatments for this condition is the segmental stabilization exercises, as well as trunk stretching. However, there is no study that associates these two treatments for nonspecific low back pain. This study will be a controlled clinical trial, randomized, prospective, single-blind with a quantitative approach that compares the efficacy of the association between segmental stabilization + trunk stretching with segmental stabilization + placebo stretching in patients with chronic nonspecific low back pain.
Detailed description
BACKGROUND: Chronic nonspecific low back pain (LCI) has a high incidence in the world population and can lead to disability. Several therapeutic approaches have been studied to treat this pathology, but most investigate only the efficacy of one form of treatment per group. Studies show the effect of Segmental Stabilization in patients with LCI, but there is a gap on the effects of the association of trunk stretches with segmental stabilization exercises on pain and disability with LCI. Therefore, the objective of this study is to investigate the effects of the association of trunk stretching and segmental stabilization exercises on chronic non-specific low back pain in the short and medium term.
Method / Design: It will be a controlled, randomized, prospective, blinded clinical trial with quantitative approach, performed at the Clinical School of Physiotherapy of the UFPB. Participants in the study were 34 subjects of both sexes, aged 18 to 80 years, with pain equal to or greater than 3 by the Numerical Pain Scale (0/10) randomized into two groups: Placebo Stretching Group + Segmental Stabilization (n = 17) who will only do exercises of placebo stretching and segmental stabilization; And Segmental Stretching-Stabilization Group (n = 17), submitted to segmental stabilization exercises associated with trunk stretches; Both groups with 12 sessions. The results on pain intensity, functional capacity, overall effect perception, and clinical-psycho-functional assessment, as per the IMMPACT recommendations for clinical trials of effectiveness and efficacy of treatment for chronic pain, will be made by a blind After the intervention, three and six months after randomization.
Discussion: Because of its design, it will be possible to blind the evaluator, the randomizer, and the patient. At the end of the research we hope to contribute to the clinical decision-making process in the choice of therapies that improve pain and disability in patients with non-specific chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSASG | Experimental | Other: SSASGStabilization and stretching group, 12 session, 60 minutes each. This group will perform stretching for back muscles in different positions, associated with stabilization exercises using a protocol developed by Richardson, 2005. |
| SSPSG | Experimental | Other: SSPSGStabilization Group, 12 session, 60 minutes each. This group will perform placebo stretching for upper limb muscles (the muscle is not stretched in it maximum extent) with stabilization exercises, using a protocol developed by Richardson, 2005. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals diagnosed with nonspecific chronic low back pain without radicular symptoms for a period exceeding 12 months,
- pain intensity greater than 3/10 points in Numerical Pain Scale
Key exclusion criteria (4 listed)
- patients who have some contraindication to perform exercises according to the American College of Sports Medicine guidelines, such as severe spinal disease (nonunion or malunion, tumors and inflammatory diseases);
- spine surgeries;
- degenerative or inflammatory disorders of the shoulder;
- patients who are in labor dispute; or are doing other types of physical therapy or drug treatment.
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 |
|---|---|---|
| SSASGBoth groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization active stretching group (SSASG) will perform stretch exercises in four sets of 30 seconds for each muscle. The active stretching exercises will last 15 minutes. The muscles that will be stretched are pectorals, latissimus dorsi, latissimus dorsi, teres major, rectus abdominis, external and internal oblique. | Other | SSASG |
| SSPSGBoth groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval. Patients of segmental stabilization placebo stretching group (SSPSG) will perform exercises that simulate stretching, but the muscles will not suffer effective stretch. The placebo stretching exercises will last 15 minutes. The muscles that will be stretched are wrist flexors and extensors muscles and fingers flexors and extensors muscles. | Other | SSPSG |
Primary outcome
Change in pain through Pain visual analogue scale
Time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
1 secondary outcome
Global Perceived Effect Scale
Time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
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 25 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving 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.
Raquel Casarotto, PhD principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSASG and SSPSG in people with Low Back Pain, run by University of Sao Paulo General Hospital at 2 sites 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 2 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in pain through Pain visual analogue scale (time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)). 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 25 Feb 2019.