<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/NCT02214199</url>
  </required_header>
  <id_info>
    <org_study_id>21/2013</org_study_id>
    <nct_id>NCT02214199</nct_id>
  </id_info>
  <brief_title>Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Almeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Andaluz Health Service</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de Almeria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this protocol is to compare degree of improvement can be achieved in&#xD;
      patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic&#xD;
      spine versus home exercises.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative&#xD;
      techniques for the ervicothoracic spine versus home exercises on pain, disability, and range&#xD;
      of movement in patients with unilateral shoulder inmingement syndrome.&#xD;
&#xD;
      Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups.&#xD;
&#xD;
      Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative&#xD;
      protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a&#xD;
      home exercise (2/week).&#xD;
&#xD;
      Main Outcome Measures: Intensity of pain, disability, and range of motion data will be&#xD;
      collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of&#xD;
      variance will be used to examine the effects of the treatment on each outcome measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disability Questionnaire Arm, Shoulder and Hand (DASHe)</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>This questionnaire asks about the symptoms as well as your ability to perform certain activities. This questionnaire has 30 items, and the results are clasified in: no difficulty, mild difficulty, moderate dificulty, severe dificulty and unable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Disability Questionnaire</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hawkins-Kennedy Test</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>The Hawkins and Kennedy test was interpreted as indicative of impingement between the greater tuberosity of the humerus against the coraco- humeral ligament, trapping all those structures which intervene. It has been reported as less reliable than the Neer impingement test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neer Test.</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>Neer's Test assesses for possible rotator cuff impingement. Stabilize the scapula and with the thumb pointing down and passively flex the arm. Pain is a positive test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>At baseline and 5 weeks</time_frame>
    <description>A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Shoulder Pain</condition>
  <condition>Manual Theapy</condition>
  <condition>Exercises Therapy</condition>
  <arm_group>
    <arm_group_label>Exercise Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manipulative Therapy Techniques</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lift Technique for mid-thoracic spine. Mobilization by low cervical spine on the upper lateral thoracic translation. Technical Dog flexion for high thoracic spine (T1-T4). Technical Dog flexion for mid-thoracic spine (T5-T8). Technical Dog flexed to low thoracic spine (T9-T12). Direct drive technology prone to mid-thoracic spine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manipulative Therapy Techniques</intervention_name>
    <arm_group_label>Manipulative Therapy Techniques</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home Exercises</intervention_name>
    <arm_group_label>Exercise Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Report of pain or dysfunction with overhead activities&#xD;
&#xD;
          2. Demonstration of pain during active shoulder movements&#xD;
&#xD;
          3. Demonstration of a positive Neer/Hawkins-Kennedy test&#xD;
&#xD;
          4. Recent onset within the last 12 months&#xD;
&#xD;
          5. Report of non-traumatic onset&#xD;
&#xD;
          6. Demonstration of a painful arc of the arm from 60° to 120° of flexion&#xD;
&#xD;
          7. Report of a baseline pain level of ≥2/10 on an 11 point numeric scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of any red flags&#xD;
&#xD;
          -  A history of frozen shoulder&#xD;
&#xD;
          -  Disorders of the acromioclavicular joint&#xD;
&#xD;
          -  Degenerative arthritis of the glenohumeral joint&#xD;
&#xD;
          -  Known calcifying tendonitis (if identified by radiograph)&#xD;
&#xD;
          -  Shoulder instability&#xD;
&#xD;
          -  Posttraumatic disorders&#xD;
&#xD;
          -  Shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine&#xD;
             disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad de Almeria</name>
      <address>
        <city>Almería</city>
        <zip>04120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.</citation>
    <PMID>25089860</PMID>
  </reference>
  <reference>
    <citation>Cook C, Learman K, Houghton S, Showalter C, O'Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014 Feb;19(1):18-24. doi: 10.1016/j.math.2013.05.007. Epub 2013 Jun 20.</citation>
    <PMID>23791561</PMID>
  </reference>
  <reference>
    <citation>Alburquerque-Sendin F, Camargo PR, Vieira A, Salvini TF. Bilateral myofascial trigger points and pressure pain thresholds in the shoulder muscles in patients with unilateral shoulder impingement syndrome: a blinded, controlled study. Clin J Pain. 2013 Jun;29(6):478-86. doi: 10.1097/AJP.0b013e3182652d65.</citation>
    <PMID>23328323</PMID>
  </reference>
  <reference>
    <citation>Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.</citation>
    <PMID>22581193</PMID>
  </reference>
  <reference>
    <citation>Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.</citation>
    <PMID>22441232</PMID>
  </reference>
  <reference>
    <citation>Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.</citation>
    <PMID>21943613</PMID>
  </reference>
  <reference>
    <citation>Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.</citation>
    <PMID>21464489</PMID>
  </reference>
  <reference>
    <citation>Koike Y, Sano H, Kinjyo T, Imamura I, Masahiro O, Goto M, Ooyama M, Kita A, Itoi E. Shoulder surface temperature and bone scintigraphy findings in patients with rotator cuff tears. Ups J Med Sci. 2011 May;116(2):142-7. doi: 10.3109/03009734.2010.545150. Epub 2011 Feb 16.</citation>
    <PMID>21323485</PMID>
  </reference>
  <reference>
    <citation>Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.</citation>
    <PMID>20186400</PMID>
  </reference>
  <reference>
    <citation>Osteras H, Torstensen TA. The dose-response effect of medical exercise therapy on impairment in patients with unilateral longstanding subacromial pain. Open Orthop J. 2010 Jan 5;4:1-6. doi: 10.2174/1874325001004010001.</citation>
    <PMID>20148093</PMID>
  </reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>April 20, 2016</last_update_submitted>
  <last_update_submitted_qc>April 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Almeria</investigator_affiliation>
    <investigator_full_name>Adelaida María Castro-Sánchez</investigator_full_name>
    <investigator_title>PhD (Lecturer)</investigator_title>
  </responsible_party>
  <keyword>Shoulder Pain</keyword>
  <keyword>Shoulder Impingement Syndrome</keyword>
  <keyword>Exercise therapy</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Shoulder Impingement Syndrome</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/NCT02214199
org study id: 21/2013
nct id: NCT02214199
lead sponsor: 
collaborator: 
has dmc: No
The objective of this protocol is to compare degree of improvement can be achieved in
      patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic
      spine versus home exercises.
Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative
      techniques for the ervicothoracic spine versus home exercises on pain, disability, and range
      of movement in patients with unilateral shoulder inmingement syndrome.

      Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups.

      Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative
      protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a
      home exercise (2/week).

      Main Outcome Measures: Intensity of pain, disability, and range of motion data will be
      collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of
      variance will be used to examine the effects of the treatment on each outcome measure.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Disability Questionnaire Arm, Shoulder and Hand (DASHe)
time frame: At baseline and 5 weeks
description: This questionnaire asks about the symptoms as well as your ability to perform certain activities. This questionnaire has 30 items, and the results are clasified in: no difficulty, mild difficulty, moderate dificulty, severe dificulty and unable
measure: Shoulder Disability Questionnaire
time frame: At baseline and 5 weeks
description: Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.
measure: Hawkins-Kennedy Test
time frame: At baseline and 5 weeks
description: The Hawkins and Kennedy test was interpreted as indicative of impingement between the greater tuberosity of the humerus against the coraco- humeral ligament, trapping all those structures which intervene. It has been reported as less reliable than the Neer impingement test.
measure: Neer Test.
time frame: At baseline and 5 weeks
description: Neer's Test assesses for possible rotator cuff impingement. Stabilize the scapula and with the thumb pointing down and passively flex the arm. Pain is a positive test.
measure: Range of Motion
time frame: At baseline and 5 weeks
description: The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.
measure: Visual Analogue Scale
time frame: At baseline and 5 weeks
description: A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.
arm group label: Exercise Therapy
arm group type: Active Comparator
description: Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
arm group label: Manipulative Therapy Techniques
arm group type: Experimental
description: Lift Technique for mid-thoracic spine. Mobilization by low cervical spine on the upper lateral thoracic translation. Technical Dog flexion for high thoracic spine (T1-T4). Technical Dog flexion for mid-thoracic spine (T5-T8). Technical Dog flexed to low thoracic spine (T9-T12). Direct drive technology prone to mid-thoracic spine.
intervention type: Other
intervention name: Manipulative Therapy Techniques
arm group label: Manipulative Therapy Techniques
intervention type: Other
intervention name: Home Exercises
arm group label: Exercise Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: Spain
citation: Rhon DI, Boyles RB, Cleland JA. One-year outcome of subacromial corticosteroid injection compared with manual physical therapy for the management of the unilateral shoulder impingement syndrome: a pragmatic randomized trial. Ann Intern Med. 2014 Aug 5;161(3):161-9. doi: 10.7326/M13-2199.
PMID: 25089860
citation: Cook C, Learman K, Houghton S, Showalter C, O'Halloran B. The addition of cervical unilateral posterior-anterior mobilisation in the treatment of patients with shoulder impingement syndrome: a randomised clinical trial. Man Ther. 2014 Feb;19(1):18-24. doi: 10.1016/j.math.2013.05.007. Epub 2013 Jun 20.
PMID: 23791561
citation: Alburquerque-Sendin F, Camargo PR, Vieira A, Salvini TF. Bilateral myofascial trigger points and pressure pain thresholds in the shoulder muscles in patients with unilateral shoulder impingement syndrome: a blinded, controlled study. Clin J Pain. 2013 Jun;29(6):478-86. doi: 10.1097/AJP.0b013e3182652d65.
PMID: 23328323
citation: Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
PMID: 22581193
citation: Camargo PR, Avila MA, Alburquerque-Sendin F, Asso NA, Hashimoto LH, Salvini TF. Eccentric training for shoulder abductors improves pain, function and isokinetic performance in subjects with shoulder impingement syndrome: a case series. Rev Bras Fisioter. 2012 Jan-Feb;16(1):74-83. doi: 10.1590/s1413-35552012000100013.
PMID: 22441232
citation: Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.
PMID: 21943613
citation: Gwilym SE, Oag HC, Tracey I, Carr AJ. Evidence that central sensitisation is present in patients with shoulder impingement syndrome and influences the outcome after surgery. J Bone Joint Surg Br. 2011 Apr;93(4):498-502. doi: 10.1302/0301-620X.93B4.25054.
PMID: 21464489
citation: Koike Y, Sano H, Kinjyo T, Imamura I, Masahiro O, Goto M, Ooyama M, Kita A, Itoi E. Shoulder surface temperature and bone scintigraphy findings in patients with rotator cuff tears. Ups J Med Sci. 2011 May;116(2):142-7. doi: 10.3109/03009734.2010.545150. Epub 2011 Feb 16.
PMID: 21323485
citation: Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.
PMID: 20186400
citation: Osteras H, Torstensen TA. The dose-response effect of medical exercise therapy on impairment in patients with unilateral longstanding subacromial pain. Open Orthop J. 2010 Jan 5;4:1-6. doi: 10.2174/1874325001004010001.
PMID: 20148093
responsible party type: Principal Investigator
investigator affiliation: Universidad de Almeria
investigator full name: Adelaida María Castro-Sánchez
investigator title: PhD (Lecturer)
mesh term: Shoulder Pain
mesh term: Shoulder Impingement Syndrome