<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/NCT03017534</url>
  </required_header>
  <id_info>
    <org_study_id>ShenandoahU (2)</org_study_id>
    <nct_id>NCT03017534</nct_id>
  </id_info>
  <brief_title>Non-Specific Effects of Manual Therapy</brief_title>
  <official_title>Non-Specific Effects of Manual Therapy: A Mixed-Methods Investigation of Contextual and Social Interactions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shenandoah University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shenandoah University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mechanism responsible for improvement following manual physical therapy techniques is&#xD;
      unknown. Previous studies have indicated both biomechanical and neurophysiologic effects&#xD;
      which may be responsible for clinical changes observed. Yet, other studies report clinical&#xD;
      changes following sham interventions. Through a mixed-methods design, this study aims to gain&#xD;
      more understanding of the social and contextual factors that may be related to the&#xD;
      improvement often observed following manual therapy techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A convenience sample will be utilized to obtain subjects. Subjects will be given a brief&#xD;
      questionnaire to identify possible contraindications for manual therapy treatment techniques&#xD;
      and exclude individuals if necessary. Subjects will be randomized into one of eight groups&#xD;
      (three variables, each with two conditions including: therapist gender match/mismatch, lab&#xD;
      coat worn/not worn, detailed explanation/colloquial conversation about the technique) and&#xD;
      participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation&#xD;
      Test. Subjects who are determined to be positive for one or more extremities will receive a&#xD;
      sham thoracic spine manipulation technique. After application of the technique, previously&#xD;
      positive limbs will be retested. Individuals who respond favorably to the sham technique upon&#xD;
      reassessment will participate in an exit interview with open-ended questions in attempt to&#xD;
      gain more insight into the factors which may have influenced their neurodynamic mobility&#xD;
      improvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Upper Limb Provocation Test (ULPT)</measure>
    <time_frame>Baseline and Immediately Post Intervention</time_frame>
    <description>Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will sidebend the subjects neck away from the extremity being tested and gradually move the extremity into the following positions: scapular depression, shoulder 90 deg abduction, shoulder 90 deg external rotation, forearm supination, wrist/finger extension, and elbow extension. The investigator will assess for symptoms at each phase throughout the test. At the onset of symptoms, sensitization maneuvers will be completed to determine if the origin of the symptoms is neurodynamic in nature and not myofascial.</description>
  </primary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Musculoskeletal Manipulations</condition>
  <condition>Placebo Effect</condition>
  <arm_group>
    <arm_group_label>Gender Match, Labcoat, Explanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Match, Labcoat, No Explanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Match, No Labcoat, Explanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Match, No Labcoat, No Explanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Mis-match, Labcoat, Explanation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Mis-match, Labcoat, No Explan.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Mis-match, No Labcoat, Explan.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gender Mis-match, No Labcoat, No Explan.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal Manual Therapy</intervention_name>
    <description>Supine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust</description>
    <arm_group_label>Gender Match, Labcoat, Explanation</arm_group_label>
    <arm_group_label>Gender Match, Labcoat, No Explanation</arm_group_label>
    <arm_group_label>Gender Match, No Labcoat, Explanation</arm_group_label>
    <arm_group_label>Gender Match, No Labcoat, No Explanation</arm_group_label>
    <arm_group_label>Gender Mis-match, Labcoat, Explanation</arm_group_label>
    <arm_group_label>Gender Mis-match, Labcoat, No Explan.</arm_group_label>
    <arm_group_label>Gender Mis-match, No Labcoat, Explan.</arm_group_label>
    <arm_group_label>Gender Mis-match, No Labcoat, No Explan.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Upper Limb Provocation Test results with limitation greater than 60 deg of elbow&#xD;
             extension at the time of measurement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cervical or lumbar pain requiring medical intervention within the last two&#xD;
             years, history of upper or lower extremity paresthesia/numbness, self reported bone&#xD;
             density disorders, previous spinal cord injury, diagnosed intervertebral disc&#xD;
             herniation, previous diagnosis of spinal stenosis or disc pathology, current&#xD;
             pregnancy, history of circulatory or neurological disorders, history of spine and&#xD;
             extremity fractures or dislocations in the last two years&#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>Sheri A Hale, PT, PhD, ATC</last_name>
    <role>Study Director</role>
    <affiliation>Shenandoah University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shenandoah University</name>
      <address>
        <city>Winchester</city>
        <state>Virginia</state>
        <zip>22601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.</citation>
    <PMID>22294849</PMID>
  </reference>
  <reference>
    <citation>Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.</citation>
    <PMID>19027342</PMID>
  </reference>
  <reference>
    <citation>O'Keeffe M, Cullinane P, Hurley J, Leahy I, Bunzli S, O'Sullivan PB, O'Sullivan K. What Influences Patient-Therapist Interactions in Musculoskeletal Physical Therapy? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2016 May;96(5):609-22. doi: 10.2522/ptj.20150240. Epub 2015 Oct 1.</citation>
    <PMID>26427530</PMID>
  </reference>
  <reference>
    <citation>Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.</citation>
    <PMID>27133031</PMID>
  </reference>
  <results_reference>
    <citation>Davis DS, Anderson IB, Carson MG, Elkins CL, Stuckey LB. Upper Limb Neural Tension and Seated Slump Tests: The False Positive Rate among Healthy Young Adults without Cervical or Lumbar Symptoms. J Man Manip Ther. 2008;16(3):136-41. doi: 10.1179/jmt.2008.16.3.136.</citation>
    <PMID>19119402</PMID>
  </results_reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shenandoah University</investigator_affiliation>
    <investigator_full_name>Aaron Hartstein</investigator_full_name>
    <investigator_title>Assistant Professor, Division of Physical Therapy</investigator_title>
  </responsible_party>
  <keyword>Patient-Therapist Interaction</keyword>
  <keyword>Non-Specific Effects</keyword>
  <keyword>Manual Therapy</keyword>
  <keyword>Neurodynamics</keyword>
  <keyword>Sham</keyword>
  <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/NCT03017534
org study id: ShenandoahU (2)
nct id: NCT03017534
lead sponsor: 
has dmc: No
The mechanism responsible for improvement following manual physical therapy techniques is
      unknown. Previous studies have indicated both biomechanical and neurophysiologic effects
      which may be responsible for clinical changes observed. Yet, other studies report clinical
      changes following sham interventions. Through a mixed-methods design, this study aims to gain
      more understanding of the social and contextual factors that may be related to the
      improvement often observed following manual therapy techniques.
A convenience sample will be utilized to obtain subjects. Subjects will be given a brief
      questionnaire to identify possible contraindications for manual therapy treatment techniques
      and exclude individuals if necessary. Subjects will be randomized into one of eight groups
      (three variables, each with two conditions including: therapist gender match/mismatch, lab
      coat worn/not worn, detailed explanation/colloquial conversation about the technique) and
      participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation
      Test. Subjects who are determined to be positive for one or more extremities will receive a
      sham thoracic spine manipulation technique. After application of the technique, previously
      positive limbs will be retested. Individuals who respond favorably to the sham technique upon
      reassessment will participate in an exit interview with open-ended questions in attempt to
      gain more insight into the factors which may have influenced their neurodynamic mobility
      improvement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Upper Limb Provocation Test (ULPT)
time frame: Baseline and Immediately Post Intervention
description: Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will sidebend the subjects neck away from the extremity being tested and gradually move the extremity into the following positions: scapular depression, shoulder 90 deg abduction, shoulder 90 deg external rotation, forearm supination, wrist/finger extension, and elbow extension. The investigator will assess for symptoms at each phase throughout the test. At the onset of symptoms, sensitization maneuvers will be completed to determine if the origin of the symptoms is neurodynamic in nature and not myofascial.
arm group label: Gender Match, Labcoat, Explanation
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique.
arm group label: Gender Match, Labcoat, No Explanation
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique.
arm group label: Gender Match, No Labcoat, Explanation
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique.
arm group label: Gender Match, No Labcoat, No Explanation
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique.
arm group label: Gender Mis-match, Labcoat, Explanation
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique.
arm group label: Gender Mis-match, Labcoat, No Explan.
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique.
arm group label: Gender Mis-match, No Labcoat, Explan.
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique.
arm group label: Gender Mis-match, No Labcoat, No Explan.
arm group type: Experimental
description: Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique.
intervention type: Procedure
intervention name: Spinal Manual Therapy
description: Supine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust
arm group label: Gender Match, Labcoat, Explanation
arm group label: Gender Match, Labcoat, No Explanation
arm group label: Gender Match, No Labcoat, Explanation
arm group label: Gender Match, No Labcoat, No Explanation
arm group label: Gender Mis-match, Labcoat, Explanation
arm group label: Gender Mis-match, Labcoat, No Explan.
arm group label: Gender Mis-match, No Labcoat, Explan.
arm group label: Gender Mis-match, No Labcoat, No Explan.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sheri A Hale, PT, PhD, ATC
role: Study Director
affiliation: Shenandoah University
facility: 
country: United States
citation: Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.
PMID: 22294849
citation: Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PMID: 19027342
citation: O'Keeffe M, Cullinane P, Hurley J, Leahy I, Bunzli S, O'Sullivan PB, O'Sullivan K. What Influences Patient-Therapist Interactions in Musculoskeletal Physical Therapy? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2016 May;96(5):609-22. doi: 10.2522/ptj.20150240. Epub 2015 Oct 1.
PMID: 26427530
citation: Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.
PMID: 27133031
citation: Davis DS, Anderson IB, Carson MG, Elkins CL, Stuckey LB. Upper Limb Neural Tension and Seated Slump Tests: The False Positive Rate among Healthy Young Adults without Cervical or Lumbar Symptoms. J Man Manip Ther. 2008;16(3):136-41. doi: 10.1179/jmt.2008.16.3.136.
PMID: 19119402
responsible party type: Principal Investigator
investigator affiliation: Shenandoah University
investigator full name: Aaron Hartstein
investigator title: Assistant Professor, Division of Physical Therapy
sharing ipd: No