Chronic Low Back PainNCT01124201
Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain
A study testing Stabilization , strengthening and stretching in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. Read more about this study
- Who is it for?
- Ages 23 to 53 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Stabilization , strengthening and stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Jun 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 23 to 53 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- low back pain for more than 3 months
- patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.
Who cannot join
- past history of back surgery
- rheumatologic disorders
- spine infections
- spine exercise training in the 3 months before study onset.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.
Read the detailed description
Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.
Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.
Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.
- Conditions
- Chronic Low Back Pain
- Being tested
- Stabilization , strengthening and stretching
- Keywords
- low back pain, clinical trial, stabilization, muscle stretching exercises, exercise therapy
- 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.
Stabilization , strengthening and stretchingOther
Also called Pressure Biofeedback Unit
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization group | Experimental | In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles. Receives: Other: Stabilization , strengthening and stretching |
| Strengthening group | Experimental | In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles. Receives: Other: Stabilization , strengthening and stretching |
| Stretching group | Experimental | Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles Receives: Other: Stabilization , strengthening and stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (visual analogical scale and McGill pain questionnaire)
Measured: Six weeks
Functional disability (Oswestry disability questionnaire)
Measured: Six weeks
TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionJun 2009
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 Chronic 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Fabio R França, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124201
- Sponsor's protocol ID
- 1249/06
- Status last verified
- Mar 2007
- First submitted
- 13 May 2010
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
PubMed 17304690MacDonald DA, Moseley GL, Hodges PW. The lumbar multifidus: does the evidence support clinical beliefs? Man Ther. 2006 Nov;11(4):254-63. doi: 10.1016/j.math.2006.02.004. Epub 2006 May 23.
PubMed 16716640Ferreira PH, Ferreira ML, Maher CG, Refshauge K, Herbert RD, Hodges PW. Changes in recruitment of transversus abdominis correlate with disability in people with chronic low back pain. Br J Sports Med. 2010 Dec;44(16):1166-72. doi: 10.1136/bjsm.2009.061515. Epub 2009 May 26.
PubMed 19474006Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017.
PubMed 14715404Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
PubMed 15867409Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.
PubMed 21120303
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
- ClinicalTrials.gov ID
- NCT01124201
- Acronym / sponsor ID
- 1249/06
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, clinical trial, stabilization, muscle stretching exercises, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 May 2010 (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 was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.
Detailed description
Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.
Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.
Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stabilization group | Experimental | Other: Stabilization , strengthening and stretchingIn the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles. |
| Strengthening group | Experimental | Other: Stabilization , strengthening and stretchingIn the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles. |
| Stretching group | Experimental | Other: Stabilization , strengthening and stretchingStretching group: erector spinae, posterior connective tissues and ischiotibials muscles |
Who may qualify
- Ages
- 23 to 53 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- low back pain for more than 3 months
- patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.
Key exclusion criteria (4 listed)
- past history of back surgery
- rheumatologic disorders
- spine infections
- spine exercise training in the 3 months before study onset.
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 |
|---|---|---|
| Stabilization , strengthening and stretchingAlso: Pressure Biofeedback UnitInterventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment. | Other | Stabilization group, Strengthening group, Stretching group |
Primary outcome
Pain (visual analogical scale and McGill pain questionnaire)
Time frame: Six weeks
Functional disability (Oswestry disability questionnaire)
Time frame: Six weeks
TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
Time frame: Six 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 14 May 2010.
- Background: PubMed 17304690Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
- Background: PubMed 16716640MacDonald DA, Moseley GL, Hodges PW. The lumbar multifidus: does the evidence support clinical beliefs? Man Ther. 2006 Nov;11(4):254-63. doi: 10.1016/j.math.2006.02.004. Epub 2006 May 23.
- Background: PubMed 19474006Ferreira PH, Ferreira ML, Maher CG, Refshauge K, Herbert RD, Hodges PW. Changes in recruitment of transversus abdominis correlate with disability in people with chronic low back pain. Br J Sports Med. 2010 Dec;44(16):1166-72. doi: 10.1136/bjsm.2009.061515. Epub 2009 May 26.
- Background: PubMed 14715404Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017.
- Background: PubMed 15867409Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
- Derived from this study: PubMed 21120303Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.
- Link to my thesis in portuguese.Link provided by the sponsor.
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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.
Fabio R França, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization , strengthening and stretching in people with Chronic Low Back Pain, run by University of Sao Paulo General Hospital 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 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 14 May 2010. 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?
Pain (visual analogical scale and McGill pain questionnaire) (time frame: Six weeks). 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 NCT01124201, 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 14 May 2010.