Chronic Low Back PainNCT02398760
Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention
A study of Chronic Low Back Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between 18 and 60 years.
- non specific chronic low back (pain for more than 3 months) with pain intensity of at least 3 points measured by pain numerical rating scale (0-10) and disability of at least 6 points in the 24-item Roland Morris Disability Questionnaire (0-24).
- classified as low or medium risk though StarT Back Screening Tool
Who cannot join
- cardiovascular and neurological pathologies
- serious pathology in the spine and pelvic.
- previous spinal surgery of at least 1 year before the trial period.
- check-list with the red flags was performed to exclusion
- classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro de Atendimento em Reabilitação e Fisioterapia - FCT/UNESP
Presidente Prudente, São Paulo, 957
About this study
Official title: Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients
Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. However, even though the studies in this area have increased, questions of this nature remaining without an adequate answer, or with limited evidence. Therefore, the investigators propose to examine the ability of clinical tests, developed to assess alterations related to clinical lumbar instability, to identify subgroups of patients with non specific chronic low back pain that may have better outcomes after a motor control exercises intervention.
Read the detailed description
Changes relative to clinical instability are well established in individuals with non specific chronic low back pain. However, in this population, these changes vary widely, characterizing them as an heterogenous group. Motor Control Exercises (MCE) aims to improve the impaired coordination of deep and superficial muscles of the trunk, to reestablish the stability of the lumbar spine reducing the common alterations in this population, and are associated with reduction of pain and disability of patients with non specific chronic low back pain. To specific assessment of the changes found in this population, clinical tests are often used: in the assessment to identify motor control alterations; during intervention as parameter for treatment progress (e.g. to increase exercises difficulty); and after intervention, to ensure that there was normalization of the motor control. There are several clinical tests to assess changes relative to clinical instability, such as: Clinical Classification Scale (CCS) to assess abdominal muscles and the coordination between superficial and deep trunk muscles; Clinical Test of Thoracolumbar Dissociation (CTTD) to assess anterior/posterior tilt while maintain a constant position of thoracolumbar junction; and the Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET) used to detect structural lumbar instability.
Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.
- Conditions
- Chronic Low Back Pain
- Being tested
- Motor Control Exercises
- Keywords
- Low Back Pain, Clinical Instability, Motor Control Exercises, Clinical Tests
- 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.
Motor Control ExercisesOther
Subjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks.
| Study group | Role | What they receive |
|---|---|---|
| Motor Control Exercises | Experimental | (Costa LOP et al. 2009; Hodges PW et al. 2009) Receives: Other: Motor Control Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (Numerical Rating Scale (0-10)
Measured: After Intervention (2 months), 6 months
Disability (measured by 24-item Roland Morris Disability Questionnaire)
Disability will be measured by 24-item Roland Morris Disability Questionnaire
Measured: After Intervention (2 months), 6 months
Secondary outcomes (6)
Function (Patient Specific Functional Scale (0-10)
Measured: After Intervention (2 months)
Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)
11-point Global Perceived Effect Scale (-5-+5)
Measured: After Intervention (2 months)
Depression (Beck Inventory (0-63)
Beck Inventory (0-63)
Measured: After Intervention (2 months)
Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)
Tampa Scale for Kinesiophobia (17-68)
Measured: After Intervention (2 months)
Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)
Fear Avoidance Beliefs Questionnaire (0-66)
Measured: After Intervention (2 months)
Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Measured: After Intervention (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionFeb 2016
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Crystian Bitencourt Soares de Oliveira, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Ruben FN Filho, PhD, Principal investigator, UNIVERSIDADE ESTADUAL PAULISTA JULIO DE MESQUITA FILHO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398760
- Sponsor's protocol ID
- UEPJMF-5402
- Status last verified
- Jun 2016
- First submitted
- 19 Mar 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hodges PW, Ferreira PH, Ferreira ML. Lumbar spine: Treatment of instability and disorders of movement control. Magee DJ, Zachazewski JE, Quillen WS, editors. Pathology and Intervention in Musculoskeletal Rehabilitation. St. Louis: Saunders Elsevier. 2009;401
Elgueta-Cancino E, Schabrun S, Danneels L, Hodges P. A clinical test of lumbopelvic control: development and reliability of a clinical test of dissociation of lumbopelvic and thoracolumbar motion. Man Ther. 2014 Oct;19(5):418-24. doi: 10.1016/j.math.2014.03.009. Epub 2014 Mar 30.
PubMed 24853256Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PubMed 16181938Kasai Y, Morishita K, Kawakita E, Kondo T, Uchida A. A new evaluation method for lumbar spinal instability: passive lumbar extension test. Phys Ther. 2006 Dec;86(12):1661-7. doi: 10.2522/ptj.20050281. Epub 2006 Oct 10.
PubMed 17033040Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
PubMed 23492976Oliveira CB, Pinto RZ, Schabrun SM, Franco MR, Morelhao PK, Silva FG, Damato TM, Negrao Filho RF. Association Between Clinical Tests Related to Motor Control Dysfunction and Changes in Pain and Disability After Lumbar Stabilization Exercises in Individuals With Chronic Low Back Pain. Arch Phys Med Rehabil. 2019 Jul;100(7):1226-1233. doi: 10.1016/j.apmr.2019.01.019. Epub 2019 Feb 26.
PubMed 30822389
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Clinical Tests and Clinical Outcomes After Motor Control Exercises Intervention for Non-specific Chronic Low Back Patients
- ClinicalTrials.gov ID
- NCT02398760
- Acronym / sponsor ID
- UEPJMF-5402
- Conditions
- Chronic Low Back Pain
- Keywords
- Low Back Pain, Clinical Instability, Motor Control Exercises, Clinical Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Mar 2015 (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.
Nowadays, the research priority in low back pain area have been find subgroup of patients with the same characteristics that might achieve better outcomes in a specific intervention. However, even though the studies in this area have increased, questions of this nature remaining without an adequate answer, or with limited evidence. Therefore, the investigators propose to examine the ability of clinical tests, developed to assess alterations related to clinical lumbar instability, to identify subgroups of patients with non specific chronic low back pain that may have better outcomes after a motor control exercises intervention.
Detailed description
Changes relative to clinical instability are well established in individuals with non specific chronic low back pain. However, in this population, these changes vary widely, characterizing them as an heterogenous group. Motor Control Exercises (MCE) aims to improve the impaired coordination of deep and superficial muscles of the trunk, to reestablish the stability of the lumbar spine reducing the common alterations in this population, and are associated with reduction of pain and disability of patients with non specific chronic low back pain. To specific assessment of the changes found in this population, clinical tests are often used: in the assessment to identify motor control alterations; during intervention as parameter for treatment progress (e.g. to increase exercises difficulty); and after intervention, to ensure that there was normalization of the motor control. There are several clinical tests to assess changes relative to clinical instability, such as: Clinical Classification Scale (CCS) to assess abdominal muscles and the coordination between superficial and deep trunk muscles; Clinical Test of Thoracolumbar Dissociation (CTTD) to assess anterior/posterior tilt while maintain a constant position of thoracolumbar junction; and the Prone Instability Test (PIT) and Passive Lumbar Extension Test (PLET) used to detect structural lumbar instability.
Therefore, primary objectives of this study are: to investigate the ability of clinical tests in predict clinical outcomes, pain and disability, in motor control exercises program, and to investigate the association of two or more tests to predict clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motor Control Exercises | Experimental | Other: Motor Control Exercises(Costa LOP et al. 2009; Hodges PW et al. 2009) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between 18 and 60 years.
- non specific chronic low back (pain for more than 3 months) with pain intensity of at least 3 points measured by pain numerical rating scale (0-10) and disability of at least 6 points in the 24-item Roland Morris Disability Questionnaire (0-24).
- classified as low or medium risk though StarT Back Screening Tool
Key exclusion criteria (5 listed)
- cardiovascular and neurological pathologies
- serious pathology in the spine and pelvic.
- previous spinal surgery of at least 1 year before the trial period.
- check-list with the red flags was performed to exclusion
- classified as high risk through StarT Back Screening Tool, due these patients have high psychological components and needed of specialized psychological attendance
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 |
|---|---|---|
| Motor Control ExercisesSubjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks. | Other | Motor Control Exercises |
Primary outcome
Pain (Numerical Rating Scale (0-10)
Time frame: After Intervention (2 months), 6 months
Disability (measured by 24-item Roland Morris Disability Questionnaire)
Time frame: After Intervention (2 months), 6 months
Disability will be measured by 24-item Roland Morris Disability Questionnaire
6 secondary outcomes
Function (Patient Specific Functional Scale (0-10)
Time frame: After Intervention (2 months)
Global Perceived Effect (11-point Global Perceived Effect Scale (-5-+5)
Time frame: After Intervention (2 months)
Depression (Beck Inventory (0-63)
Time frame: After Intervention (2 months)
Kinesiophobia (Tampa Scale for Kinesiophobia (17-68)
Time frame: After Intervention (2 months)
Kinesiophobia (Fear Avoidance Beliefs Questionnaire (0-66)
Time frame: After Intervention (2 months)
Kinesiophobia (Photograph Series of Daily Activities - Short Electronic Version (PHODA-SEV) (0-100)
Time frame: After Intervention (2 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 Jun 2016.
- BackgroundHodges PW, Ferreira PH, Ferreira ML. Lumbar spine: Treatment of instability and disorders of movement control. Magee DJ, Zachazewski JE, Quillen WS, editors. Pathology and Intervention in Musculoskeletal Rehabilitation. St. Louis: Saunders Elsevier. 2009;401
- Background: PubMed 24853256Elgueta-Cancino E, Schabrun S, Danneels L, Hodges P. A clinical test of lumbopelvic control: development and reliability of a clinical test of dissociation of lumbopelvic and thoracolumbar motion. Man Ther. 2014 Oct;19(5):418-24. doi: 10.1016/j.math.2014.03.009. Epub 2014 Mar 30.
- Background: PubMed 16181938Hicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
- Background: PubMed 17033040Kasai Y, Morishita K, Kawakita E, Kondo T, Uchida A. A new evaluation method for lumbar spinal instability: passive lumbar extension test. Phys Ther. 2006 Dec;86(12):1661-7. doi: 10.2522/ptj.20050281. Epub 2006 Oct 10.
- Background: PubMed 23492976Bystrom MG, Rasmussen-Barr E, Grooten WJ. Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine (Phila Pa 1976). 2013 Mar 15;38(6):E350-8. doi: 10.1097/BRS.0b013e31828435fb.
- Derived from this study: PubMed 30822389Oliveira CB, Pinto RZ, Schabrun SM, Franco MR, Morelhao PK, Silva FG, Damato TM, Negrao Filho RF. Association Between Clinical Tests Related to Motor Control Dysfunction and Changes in Pain and Disability After Lumbar Stabilization Exercises in Individuals With Chronic Low Back Pain. Arch Phys Med Rehabil. 2019 Jul;100(7):1226-1233. doi: 10.1016/j.apmr.2019.01.019. Epub 2019 Feb 26.
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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.
Ruben FN Filho, PhD principal investigator
UNIVERSIDADE ESTADUAL PAULISTA JULIO DE MESQUITA FILHO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Low Back Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 5 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 Jun 2016. 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 (Numerical Rating Scale (0-10) (time frame: After Intervention (2 months), 6 months). The study lists 2 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 NCT02398760, 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 Jun 2016.