<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/NCT03794830</url>
  </required_header>
  <id_info>
    <org_study_id>041218</org_study_id>
    <nct_id>NCT03794830</nct_id>
  </id_info>
  <brief_title>The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain</brief_title>
  <official_title>The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Extremadura</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Extremadura</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary focus of this study is to know the influence of sacroiliac joint manipulation on&#xD;
      low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One of the main problems faced by physiotherapists in primary care is low back pain with or&#xD;
      without radiation to lower limbs. Nowadays, there are a lot of types of low back pain&#xD;
      interventions, yet despite the vast amount of research findings, the evidence remains&#xD;
      contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in&#xD;
      acute low back pain but not in chronic pain; conservative interventions (ultrasound,&#xD;
      interferential currents, mechanical traction and massage) have been studied and found&#xD;
      ineffective.&#xD;
&#xD;
      A total of 151 low back pain patients with or without radiation to lower limbs between 18-70&#xD;
      years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain)&#xD;
      voluntarily entered the study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale (VAS)</measure>
    <time_frame>1 week</time_frame>
    <description>Pain assessment from 0 to 10. 0: no pain 10: maximum pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oswestry disability index (ODI)</measure>
    <time_frame>1 week</time_frame>
    <description>disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland Morris questionnaire</measure>
    <time_frame>1 week</time_frame>
    <description>disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>digital algometer (Wagner, FPIX model)</measure>
    <time_frame>1 week</time_frame>
    <description>Pain threshold assessment by pressing the sensitive points of the muscle</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Sacroiliac Disorder</condition>
  <arm_group>
    <arm_group_label>manipulation group (MG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electrotherapy group (EG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions of electrotherapy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>manipulation group (MG)</intervention_name>
    <description>Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks</description>
    <arm_group_label>manipulation group (MG)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electrotheraphy group (EG)</intervention_name>
    <description>Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)</description>
    <arm_group_label>electrotherapy group (EG)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  dysfunction or sacroiliac joint hypomobility (SI)&#xD;
&#xD;
          -  having stopped taking anti-inflammatory medicines or analgesics three days before the&#xD;
             study began&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  destructive injuries of the spine and pelvis&#xD;
&#xD;
          -  fractures&#xD;
&#xD;
          -  lumbar surgery&#xD;
&#xD;
          -  sacroiliac instability&#xD;
&#xD;
          -  spondylolisthesis&#xD;
&#xD;
          -  pregnancy in progress&#xD;
&#xD;
          -  cauda equina syndrome&#xD;
&#xD;
          -  abdominal aneurysm&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  inflammatory arthritis&#xD;
&#xD;
          -  tumors&#xD;
&#xD;
          -  osteoporosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Antonio JA Rodriguez-Pastor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mª Dolores MD Apolo-Arenas, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Berta BC Caro-Puértolas, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alejandro AC Caña-Pino, PT,MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad de Extremadura</name>
      <address>
        <city>Badajoz</city>
        <zip>06071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Extremadura</investigator_affiliation>
    <investigator_full_name>Alejandro Caña Pino</investigator_full_name>
    <investigator_title>Principal Investigator. Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain</investigator_title>
  </responsible_party>
  <keyword>sacroiliac joint</keyword>
  <keyword>low back pain</keyword>
  <keyword>Osteopathic manipulation</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>
  <!-- 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/NCT03794830
org study id: 041218
nct id: NCT03794830
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary focus of this study is to know the influence of sacroiliac joint manipulation on
      low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint
One of the main problems faced by physiotherapists in primary care is low back pain with or
      without radiation to lower limbs. Nowadays, there are a lot of types of low back pain
      interventions, yet despite the vast amount of research findings, the evidence remains
      contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in
      acute low back pain but not in chronic pain; conservative interventions (ultrasound,
      interferential currents, mechanical traction and massage) have been studied and found
      ineffective.

      A total of 151 low back pain patients with or without radiation to lower limbs between 18-70
      years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain)
      voluntarily entered the study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: visual analogue scale (VAS)
time frame: 1 week
description: Pain assessment from 0 to 10. 0: no pain 10: maximum pain
measure: Oswestry disability index (ODI)
time frame: 1 week
description: disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):
measure: Roland Morris questionnaire
time frame: 1 week
description: disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
measure: digital algometer (Wagner, FPIX model)
time frame: 1 week
description: Pain threshold assessment by pressing the sensitive points of the muscle
arm group label: manipulation group (MG)
arm group type: Experimental
description: Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
arm group label: electrotherapy group (EG)
arm group type: Active Comparator
description: Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions of electrotherapy).
intervention type: Other
intervention name: manipulation group (MG)
description: Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
arm group label: manipulation group (MG)
intervention type: Other
intervention name: electrotheraphy group (EG)
description: Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)
arm group label: electrotherapy group (EG)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Antonio JA Rodriguez-Pastor, PhD
role: Principal Investigator
affiliation: Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
last name: Mª Dolores MD Apolo-Arenas, PhD
role: Study Director
affiliation: Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
last name: Berta BC Caro-Puértolas, PhD
role: Study Director
affiliation: Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
last name: Alejandro AC Caña-Pino, PT,MSc
role: Principal Investigator
affiliation: Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Extremadura
investigator full name: Alejandro Caña Pino
investigator title: Principal Investigator. Medical Surgical-Therapy Department, Universidad de Extremadura Facultad de Medicina, Badajoz, Spain
mesh term: Back Pain
mesh term: Low Back Pain