<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02985892</url>
  </required_header>
  <id_info>
    <org_study_id>EATSSSE</org_study_id>
    <nct_id>NCT02985892</nct_id>
  </id_info>
  <brief_title>Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain</brief_title>
  <official_title>Effects of Association of Trunk Stretching and Segmental Stabilization Exercises in Chronic Unspecific Low Back Pain: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Paraíba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of chronic nonspecific low back pain is the highest in the world population and&#xD;
      can lead to disability. One of the standards treatments for this condition is the segmental&#xD;
      stabilization exercises, as well as trunk stretching. However, there is no study that&#xD;
      associates these two treatments for nonspecific low back pain. This study will be a&#xD;
      controlled clinical trial, randomized, prospective, single-blind with a quantitative approach&#xD;
      that compares the efficacy of the association between segmental stabilization + trunk&#xD;
      stretching with segmental stabilization + placebo stretching in patients with chronic&#xD;
      nonspecific low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Chronic nonspecific low back pain (LCI) has a high incidence in the world&#xD;
      population and can lead to disability. Several therapeutic approaches have been studied to&#xD;
      treat this pathology, but most investigate only the efficacy of one form of treatment per&#xD;
      group. Studies show the effect of Segmental Stabilization in patients with LCI, but there is&#xD;
      a gap on the effects of the association of trunk stretches with segmental stabilization&#xD;
      exercises on pain and disability with LCI. Therefore, the objective of this study is to&#xD;
      investigate the effects of the association of trunk stretching and segmental stabilization&#xD;
      exercises on chronic non-specific low back pain in the short and medium term.&#xD;
&#xD;
      Method / Design: It will be a controlled, randomized, prospective, blinded clinical trial&#xD;
      with quantitative approach, performed at the Clinical School of Physiotherapy of the UFPB.&#xD;
      Participants in the study were 34 subjects of both sexes, aged 18 to 80 years, with pain&#xD;
      equal to or greater than 3 by the Numerical Pain Scale (0/10) randomized into two groups:&#xD;
      Placebo Stretching Group + Segmental Stabilization (n = 17) who will only do exercises of&#xD;
      placebo stretching and segmental stabilization; And Segmental Stretching-Stabilization Group&#xD;
      (n = 17), submitted to segmental stabilization exercises associated with trunk stretches;&#xD;
      Both groups with 12 sessions. The results on pain intensity, functional capacity, overall&#xD;
      effect perception, and clinical-psycho-functional assessment, as per the IMMPACT&#xD;
      recommendations for clinical trials of effectiveness and efficacy of treatment for chronic&#xD;
      pain, will be made by a blind After the intervention, three and six months after&#xD;
      randomization.&#xD;
&#xD;
      Discussion: Because of its design, it will be possible to blind the evaluator, the&#xD;
      randomizer, and the patient. At the end of the research we hope to contribute to the clinical&#xD;
      decision-making process in the choice of therapies that improve pain and disability in&#xD;
      patients with non-specific chronic low back pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain through Pain visual analogue scale</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Perceived Effect Scale</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual analogue scale for anxiety</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Symptoms and Adverse events or side effects</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Instrument for Measuring Patient Satisfaction (MedRisk)</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Roland Morris Disability Questionnaire</measure>
    <time_frame>Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>SSASG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SSPSG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SSASG</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>SSASG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SSPSG</intervention_name>
    <description>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.&#xD;
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.</description>
    <arm_group_label>SSPSG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals diagnosed with nonspecific chronic low back pain without radicular&#xD;
             symptoms for a period exceeding 12 months,&#xD;
&#xD;
          -  pain intensity greater than 3/10 points in Numerical Pain Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have some contraindication to perform exercises according to the American&#xD;
             College of Sports Medicine guidelines, such as severe spinal disease (nonunion or&#xD;
             malunion, tumors and inflammatory diseases);&#xD;
&#xD;
          -  spine surgeries;&#xD;
&#xD;
          -  degenerative or inflammatory disorders of the shoulder;&#xD;
&#xD;
          -  patients who are in labor dispute; or are doing other types of physical therapy or&#xD;
             drug treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raquel Casarotto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carina Carvalho Correia Coutinho</name>
      <address>
        <city>Joao Pessoa</city>
        <state>Paraiba</state>
        <zip>58030-390</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carina Carvalho</name>
      <address>
        <city>João Pessoa</city>
        <state>Paraíba</state>
        <zip>58051900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical therapy</keyword>
  <keyword>Muscle Stretching Exercises</keyword>
  <keyword>Low Back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02985892
org study id: EATSSSE
nct id: NCT02985892
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
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)
measure: Global Perceived Effect Scale
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Beck Depression Inventory
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Visual analogue scale for anxiety
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Symptoms and Adverse events or side effects
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Instrument for Measuring Patient Satisfaction (MedRisk)
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
measure: Roland Morris Disability Questionnaire
time frame: Before the treatment and after the treatment (immediately after the treatment, and 3 and 6 months after treatment)
arm group label: SSASG
arm group type: Experimental
description: 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.
arm group label: SSPSG
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: SSASG
description: 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.
arm group label: SSASG
intervention type: Other
intervention name: SSPSG
description: 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.
arm group label: SSPSG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Raquel Casarotto, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No