<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/NCT02976974</url>
  </required_header>
  <id_info>
    <org_study_id>UMA MTEAC</org_study_id>
    <nct_id>NCT02976974</nct_id>
  </id_info>
  <brief_title>Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.</brief_title>
  <acronym>MTEAC</acronym>
  <official_title>Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaga</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive&#xD;
      capsulitis of the shoulder will be studied. Furthermore, different biomechanic and&#xD;
      psychosocial factors will be measured with a nine month follow-up&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the&#xD;
      shoulder joint. There exist different clinical trial related to this pathology, however a&#xD;
      lack of information of both efficacy and methodology used in manual therapy treatment remains&#xD;
      unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the&#xD;
      improvement after different conservative treatments is also unknown. Besides, little is known&#xD;
      about which factors are more correlated with pain and function.Thus, biomechanic and&#xD;
      psychosocial factors together with ultrasound measurements and blood glucose concentration&#xD;
      (see &quot;outcome and secondary measures&quot; section ) will be analyzed before and after the&#xD;
      treatment, with a nine months follow up. Results will be spread showing short term effects&#xD;
      and long term effects in different publications.&#xD;
&#xD;
      Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and&#xD;
      therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and&#xD;
      function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose&#xD;
      concentration, before and after the treatments proposed with a nine months follow up.&#xD;
&#xD;
      Method&#xD;
&#xD;
      This study is designed as a clinical trial, with two randomised parallel groups comparing two&#xD;
      different conservative intervention (MT vs MT+E) (See &quot;Arms and Interventions&quot; section). It&#xD;
      will be carried out in different Hospital and primary care centers where patients suffering&#xD;
      from adhesive capsulitis of the shoulder will be asked to participate in the project. If&#xD;
      participants are eligible then they will be include in the study. All participants will have&#xD;
      to sign informed consent after be shown about the whole project as by written (informative&#xD;
      sheet) as by speech from the physiotherapist in charge.&#xD;
&#xD;
      Once include in the study definitely, all factors detailed (see &quot;outcome measures&quot; section)&#xD;
      will be measured. Also, every factor will be correlated with shoulder pain and function. This&#xD;
      way, the investigators could predict which factor are more correlated with. Furthermore, if&#xD;
      significant correlations are found, such factors could be used as predictors or monitoring&#xD;
      tool when patients with shoulder adhesive capsulitis are treated&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 30, 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pressure algometry at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Assessment of central sensitization:&#xD;
It will be carried out on the affected and unaffected shoulder (mid belly of medium deltoid muscle: 2 cm under acromion). Also, the quadriceps rectus femoris (ipsilateral to frozen shoulder, middle spine iliac antero-superior (SIAS) and top patella) will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline ultrasonography at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Different structures will be measured by ultrasonography such as tendons (supraspinatus, infraspinatus, subscapularis and long head biceps tendon) and ligaments (coracohumeral and upper glenohumeral ligaments). Furthermore, acromiohumeral distance and coracohumeral distance will be analyzed. In addition, presence of neovascularization will be studied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline electromyography at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>It will be investigated the surface electromyographic (EMG) relative muscle activity of the upper (UT) and lower trapezius (LT) as well as serratus anterior (SA) muscles during both ascending and descending phases of arm elevation in participants with adhesive capsulitis of the shoulder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline dynamometry at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Assessment of shoulder force (unit of measure: kilograms) in seated position (handheld dynamometer) :&#xD;
Elevation in the scapular plane at 90°&#xD;
Outer rotation with flexion elbow at 90°&#xD;
Inner rotation with flexion elbow at 90°&#xD;
Lift off position: Patient places arm behind the back, 90° flexion elbow.&#xD;
Three measurements will be carried out in each position. The mean will be the final value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline blood glucose concentration at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>To assess metabolic factors venous blood samples will be collected.Information about a person's average levels of blood glucose, over the past 3 months (A1C) will be obtained with the &quot;A1C&quot; test or glycohemoglobin test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline range of movement (ROM) at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of mobility in different planes:&#xD;
Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline heart rate variability (HRV) at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of Autonomic nervous system activity:&#xD;
Resting HRV provides quantitative information regarding cardiac autonomic tone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline CSI questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of central sensitization (CS):&#xD;
The Central Sensitization Inventory (CSI) was developed to assess the overlapping health-related symptom dimensions of CS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline &quot;pain vigilance and awareness&quot; questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>The Pain Vigilance and Awareness Questionnaire(PVAQ) is a 16-item measure of pain-related awareness and vigilance. It shows predicted relations with measures of attention-related pain coping strategies, supporting the validity of the total score as a measure of attention to pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline pain Catastrophizing Scale questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Assessment of the mechanisms by which catastrophizing impacts on pain experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline short form-36 (SF-36) at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of Quality of life:&#xD;
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline McGill questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of pain:&#xD;
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Assessment of quality of life.:&#xD;
This questionnaire measure upper limb symptoms as well as patient ability to do certain activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months</measure>
    <time_frame>time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)</time_frame>
    <description>Measurement of Autonomic nervous system activity:&#xD;
The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Manual therapy (MT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic exercise (E)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E: Therapeutic Exercise.&#xD;
Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing &quot;push up&quot; on the wall.&#xD;
Thoracic column movements: Flexion-extension</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy</intervention_name>
    <description>Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.</description>
    <arm_group_label>Manual therapy (MT)</arm_group_label>
    <arm_group_label>Therapeutic exercise (E)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic exercise</intervention_name>
    <description>Shoulder extension: Elastic bands.&#xD;
Shoulder flexion: Elastic bands&#xD;
Shoulder external rotation: Elastic bands.&#xD;
Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing &quot;push up&quot; on the wall.&#xD;
Thoracic column movements: Flexion-extension</description>
    <arm_group_label>Therapeutic exercise (E)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People suffering from adhesive capsulitis as indicated by passive range of motion loss&#xD;
             &gt;25% in at least 2 movement planes, together with at least 50% loss of passive&#xD;
             external rotation in comparison with the uninvolved shoulder.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shoulder pain that was deemed to be originating from any passive and/or neck movement&#xD;
             or if there was a neurological impairment, osteoporosis, haemophilia and/or&#xD;
             malignancies&#xD;
&#xD;
          -  Corticoid injections during the six months prior to the study&#xD;
&#xD;
          -  Analgesic-antiinflammatory medication intake during the intervention phase of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ALEJANDRO LUQUE-SUAREZ, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNIVERSITY OF MALAGA, SPAIN</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ANTONIO RONDON-RAMOS, PT</last_name>
    <phone>0034 610566313</phone>
    <email>antonio.rondon.sspa@juntadeandalucia.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Las Albarizas primary care centre</name>
      <address>
        <city>Fuengirola</city>
        <state>Malaga</state>
        <zip>29603</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Luis Díaz Cerrillo, PT</last_name>
      <phone>+34627911441</phone>
      <email>juanlu1x2@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Susana Clavero Cano, PT</last_name>
      <phone>+34600142510</phone>
      <email>susclavero@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Las Lagunas Care Centre</name>
      <address>
        <city>Fuengirola</city>
        <state>Malaga</state>
        <zip>29651</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Rondón Ramos, PT</last_name>
      <phone>+34600142611</phone>
      <email>antonio.rondon.sspa@juntadeandalucia.es</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>San Pedro primary care centre</name>
      <address>
        <city>Marbella</city>
        <state>Malaga</state>
        <zip>29670</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gina Rocío Ariza Hurtado, PT</last_name>
      <email>ginarizado@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Malaga</investigator_affiliation>
    <investigator_full_name>Alejandro Luque-Suarez</investigator_full_name>
    <investigator_title>Efficacy of manual therapy and exercise in patients with shoulder adhesive capsulitis. Which biomechanics/psychological factors are more correlated with?</investigator_title>
  </responsible_party>
  <keyword>chronic pain</keyword>
  <keyword>central sensitization</keyword>
  <keyword>function</keyword>
  <keyword>force</keyword>
  <keyword>ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The results obtained in this project will be disseminated to the research community through different vias such as publications and oral/poster presentations</ipd_description>
  </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/NCT02976974
org study id: UMA MTEAC
nct id: NCT02976974
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive
      capsulitis of the shoulder will be studied. Furthermore, different biomechanic and
      psychosocial factors will be measured with a nine month follow-up
Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the
      shoulder joint. There exist different clinical trial related to this pathology, however a
      lack of information of both efficacy and methodology used in manual therapy treatment remains
      unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the
      improvement after different conservative treatments is also unknown. Besides, little is known
      about which factors are more correlated with pain and function.Thus, biomechanic and
      psychosocial factors together with ultrasound measurements and blood glucose concentration
      (see "outcome and secondary measures" section ) will be analyzed before and after the
      treatment, with a nine months follow up. Results will be spread showing short term effects
      and long term effects in different publications.

      Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and
      therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and
      function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose
      concentration, before and after the treatments proposed with a nine months follow up.

      Method

      This study is designed as a clinical trial, with two randomised parallel groups comparing two
      different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It
      will be carried out in different Hospital and primary care centers where patients suffering
      from adhesive capsulitis of the shoulder will be asked to participate in the project. If
      participants are eligible then they will be include in the study. All participants will have
      to sign informed consent after be shown about the whole project as by written (informative
      sheet) as by speech from the physiotherapist in charge.

      Once include in the study definitely, all factors detailed (see "outcome measures" section)
      will be measured. Also, every factor will be correlated with shoulder pain and function. This
      way, the investigators could predict which factor are more correlated with. Furthermore, if
      significant correlations are found, such factors could be used as predictors or monitoring
      tool when patients with shoulder adhesive capsulitis are treated
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
measure: Change from baseline pressure algometry at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Assessment of central sensitization:
It will be carried out on the affected and unaffected shoulder (mid belly of medium deltoid muscle: 2 cm under acromion). Also, the quadriceps rectus femoris (ipsilateral to frozen shoulder, middle spine iliac antero-superior (SIAS) and top patella) will be assessed.
measure: Change from baseline ultrasonography at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Different structures will be measured by ultrasonography such as tendons (supraspinatus, infraspinatus, subscapularis and long head biceps tendon) and ligaments (coracohumeral and upper glenohumeral ligaments). Furthermore, acromiohumeral distance and coracohumeral distance will be analyzed. In addition, presence of neovascularization will be studied.
measure: Change from baseline electromyography at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: It will be investigated the surface electromyographic (EMG) relative muscle activity of the upper (UT) and lower trapezius (LT) as well as serratus anterior (SA) muscles during both ascending and descending phases of arm elevation in participants with adhesive capsulitis of the shoulder
measure: Change from baseline dynamometry at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Assessment of shoulder force (unit of measure: kilograms) in seated position (handheld dynamometer) :
Elevation in the scapular plane at 90°
Outer rotation with flexion elbow at 90°
Inner rotation with flexion elbow at 90°
Lift off position: Patient places arm behind the back, 90° flexion elbow.
Three measurements will be carried out in each position. The mean will be the final value.
measure: Change from baseline blood glucose concentration at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: To assess metabolic factors venous blood samples will be collected.Information about a person's average levels of blood glucose, over the past 3 months (A1C) will be obtained with the "A1C" test or glycohemoglobin test.
measure: Change from baseline range of movement (ROM) at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of mobility in different planes:
Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.
measure: Change from baseline heart rate variability (HRV) at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of Autonomic nervous system activity:
Resting HRV provides quantitative information regarding cardiac autonomic tone.
measure: Change from baseline CSI questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of central sensitization (CS):
The Central Sensitization Inventory (CSI) was developed to assess the overlapping health-related symptom dimensions of CS
measure: Change from baseline "pain vigilance and awareness" questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: The Pain Vigilance and Awareness Questionnaire(PVAQ) is a 16-item measure of pain-related awareness and vigilance. It shows predicted relations with measures of attention-related pain coping strategies, supporting the validity of the total score as a measure of attention to pain
measure: Change from baseline pain Catastrophizing Scale questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Assessment of the mechanisms by which catastrophizing impacts on pain experience.
measure: Change from baseline short form-36 (SF-36) at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of Quality of life:
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
measure: Change from baseline McGill questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of pain:
The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.
measure: Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Assessment of quality of life.:
This questionnaire measure upper limb symptoms as well as patient ability to do certain activities.
measure: Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months
time frame: time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
description: Measurement of Autonomic nervous system activity:
The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score
arm group label: Manual therapy (MT)
arm group type: Experimental
description: MT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.
arm group label: Therapeutic exercise (E)
arm group type: Experimental
description: E: Therapeutic Exercise.
Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall.
Thoracic column movements: Flexion-extension
intervention type: Other
intervention name: Manual therapy
description: Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.
arm group label: Manual therapy (MT)
arm group label: Therapeutic exercise (E)
intervention type: Other
intervention name: Therapeutic exercise
description: Shoulder extension: Elastic bands.
Shoulder flexion: Elastic bands
Shoulder external rotation: Elastic bands.
Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall.
Thoracic column movements: Flexion-extension
arm group label: Therapeutic exercise (E)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ALEJANDRO LUQUE-SUAREZ, PT, PhD
role: Principal Investigator
affiliation: UNIVERSITY OF MALAGA, SPAIN
last name: ANTONIO RONDON-RAMOS, PT
phone: 0034 610566313
email: antonio.rondon.sspa@juntadeandalucia.es
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Malaga
investigator full name: Alejandro Luque-Suarez
investigator title: Efficacy of manual therapy and exercise in patients with shoulder adhesive capsulitis. Which biomechanics/psychological factors are more correlated with?
mesh term: Shoulder Pain
mesh term: Bursitis
sharing ipd: Yes
ipd description: The results obtained in this project will be disseminated to the research community through different vias such as publications and oral/poster presentations