<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/NCT03791892</url>
  </required_header>
  <id_info>
    <org_study_id>RiphahI Wajeeha</org_study_id>
    <nct_id>NCT03791892</nct_id>
  </id_info>
  <brief_title>Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive Capsulitis</brief_title>
  <official_title>The Effects of Shoulder Mobilization Following Supra Scapular Nerve Block in Adhesive</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riphah International University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riphah International University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Those shoulder patients who fulfill inclusion criteria are divided into two groups.&#xD;
      Supervised exercises will be performed by both groups. Kaltenborn mobilization will be&#xD;
      applied to patient in experimental group only. Assessment will be done on baseline, 7th and&#xD;
      post visit. A total 38 subjects were included in study who met inclusion criteria. Number of&#xD;
      patients in both groups was 19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adhesive capsulitis is one of the most common debilitating musculoskeletal complaints seen in&#xD;
      physiotherapy practice. Adhesive capsulitis is a benign, self-limiting condition of unknown&#xD;
      etiology characterized by painful and limited active and passive gleno-humeral range of&#xD;
      motion of ≥ 25% in at least two directions most notably shoulder abduction and external&#xD;
      rotation. Prevalence of adhesive capsulitis is 2% - 5% in general population.1 Primary&#xD;
      adhesive capsulitis and frozen shoulder are current terms used to describe an insidious onset&#xD;
      of painful stiffness of the gleno-humeral joint. Secondary adhesive capsulitis, on the other&#xD;
      hand, is associated with a known predisposing condition of the shoulder (eg, humerus&#xD;
      fracture, shoulder dislocation, avascular necrosis, osteoarthritis, or stroke.&#xD;
&#xD;
      The range of motion (ROM) impairments associated with primary adhesive capsulitis can impact&#xD;
      a patient's ability to participate in self-care and occupational activities. Even though this&#xD;
      condition is considered self-limiting, with most patients having spontaneous resolution&#xD;
      within 3 years, some patients can suffer long-term pain and restricted shoulder motion well&#xD;
      beyond 3 years. A disability of this duration places severe emotional and economic hardship&#xD;
      on the afflicted person. Most patients are unwilling to suffer this pain, prolonged&#xD;
      disability, and sleep deprivation without seeking treatment.&#xD;
&#xD;
      Currently, no standard medical, surgical, or therapy regimen is universally accepted as the&#xD;
      most efficacious treatment for restoring motion in patients with shoulder adhesive&#xD;
      capsulitis. While physical therapy is commonly prescribed for this condition, some studies&#xD;
      have found little treatment benefit. Rehabilitation programs consisting of exercise, massage,&#xD;
      and modalities have been shown to improve shoulder ROM in all planes except external and&#xD;
      internal rotation. There is evidence, however, that joint mobilization procedures can lessen&#xD;
      the associated gleno-humeral rotational deficits characteristic of this condition, especially&#xD;
      external rotation. The optimal direction of force and movement application for the joint&#xD;
      mobilization to restore external rotation, however, is not clear. Traditionally, physical&#xD;
      therapists have used an anterior glide of the humeral head on the glenoid technique to&#xD;
      improve external rotation ROM, a choice based on the &quot;convex-on-concave&quot; concept of joint&#xD;
      surface motion. In contrast, Roubal et al used a posteriorly directed glide manipulation&#xD;
      based on the &quot;capsular constraint mechanism&quot; to restore external as well as internal rotation&#xD;
      ROM.Supra-scapular nerve block (SSNB) is a safe and effective method to treat pain in chronic&#xD;
      diseases that affect the shoulder. The technique consists of injecting anaesthetics in&#xD;
      supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs&#xD;
      pending beside the body.The technique consists of injecting anesthetic in supraspinatus fossa&#xD;
      of affected shoulder, with the patient sitting down and upper limbs pending beside the body.3&#xD;
      In this study keltenborn joint mobilization will be use as intervention is to restore the&#xD;
      joint play and in order to normalize the rolling and gliding of any joint, which are&#xD;
      necessary for the active normal and non-painful movement. Some general exercises also help us&#xD;
      to treat adhesive capsulitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 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>
    <intervention_model_description>Experimental</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>change from baseline.This tool is used to measure pain intensity</time_frame>
    <description>NPRS) is a scale used to find the level of pain intensity. At the time of treatment session intensity of pain is mainly the center of attention of the treatment. This pain scale is used in routine in clinical setting during the application of treatment procedure to evaluate the intensity of pain. NPRS has good validity and reliability. In our study we evaluate the status of pain in shoulder in individuals with adhesive capsulitis. The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects the whole number (0-10). '0' indicates no pain whereas '10' indicates extreme pain. In our study NPRS values are taken at base line, 7th visit and post visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Goniometer</measure>
    <time_frame>change from baseline.This tool is used to measure shoulder ranges</time_frame>
    <description>In physical therapy goniometer is utilized to measures range of movement joint angles in the body.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SHOULDER PAIN AND DISABILITY INDEX (SPADI)</measure>
    <time_frame>change from baseline.This tool is used to measure shoulder disability</time_frame>
    <description>By using this tool we can access pain as well as level of disability of patient having frozen shoulder. This tool consists of 13 questions. A therapist asked questions to patients. It takes 5 to 10 minutes to finish the questionnaire n marked accordingly. SPADI values were taken at baseline, 7th visit and post visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Adhesive Capsulitis</condition>
  <arm_group>
    <arm_group_label>Shoulder mobilization Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kaltenborn mobilization will be applied to patient in experimental group only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional treatment Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of conventional treatment that includes stretching and strengthening exercises of shoulder.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shoulder mobilization Group</intervention_name>
    <description>Suprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps)</description>
    <arm_group_label>Shoulder mobilization Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Treatment Group</intervention_name>
    <description>Suprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps)</description>
    <arm_group_label>Conventional treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40 to 70 years&#xD;
&#xD;
          -  Both male and female&#xD;
&#xD;
          -  Unilateral cases.&#xD;
&#xD;
          -  Grade 1 and 2 phase of adhesive shoulder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Traumatic /fracture in upper extremity&#xD;
&#xD;
          -  Patients with malignancy&#xD;
&#xD;
          -  Post-operative shoulder&#xD;
&#xD;
          -  Patient under steroid therapy&#xD;
&#xD;
          -  Bilateral cases.&#xD;
&#xD;
          -  Grade 3 stage of frozen shoulder.&#xD;
&#xD;
          -  Patient with sever osteo-arthritis&#xD;
&#xD;
          -  Patient with diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>imran Amjad, phd*</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imran Amjad</name>
      <address>
        <city>Islamabad</city>
        <state>Punjab</state>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riphah International University</name>
      <address>
        <city>Islamabad</city>
        <zip>44000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <reference>
    <citation>Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.</citation>
    <PMID>18475240</PMID>
  </reference>
  <reference>
    <citation>Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.</citation>
    <PMID>16282408</PMID>
  </reference>
  <reference>
    <citation>Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.</citation>
    <PMID>29992159</PMID>
  </reference>
  <reference>
    <citation>Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.</citation>
    <PMID>20110457</PMID>
  </reference>
  <reference>
    <citation>Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.</citation>
    <PMID>10208704</PMID>
  </reference>
  <reference>
    <citation>Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.</citation>
    <PMID>16356983</PMID>
  </reference>
  <reference>
    <citation>Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687.</citation>
    <PMID>17031613</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>May 15, 2019</last_update_submitted>
  <last_update_submitted_qc>May 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adhesive capsulitis</keyword>
  <keyword>suprascapular nerve</keyword>
  <keyword>shoulder mobilization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</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/NCT03791892
org study id: RiphahI Wajeeha
nct id: NCT03791892
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Those shoulder patients who fulfill inclusion criteria are divided into two groups.
      Supervised exercises will be performed by both groups. Kaltenborn mobilization will be
      applied to patient in experimental group only. Assessment will be done on baseline, 7th and
      post visit. A total 38 subjects were included in study who met inclusion criteria. Number of
      patients in both groups was 19.
Adhesive capsulitis is one of the most common debilitating musculoskeletal complaints seen in
      physiotherapy practice. Adhesive capsulitis is a benign, self-limiting condition of unknown
      etiology characterized by painful and limited active and passive gleno-humeral range of
      motion of ≥ 25% in at least two directions most notably shoulder abduction and external
      rotation. Prevalence of adhesive capsulitis is 2% - 5% in general population.1 Primary
      adhesive capsulitis and frozen shoulder are current terms used to describe an insidious onset
      of painful stiffness of the gleno-humeral joint. Secondary adhesive capsulitis, on the other
      hand, is associated with a known predisposing condition of the shoulder (eg, humerus
      fracture, shoulder dislocation, avascular necrosis, osteoarthritis, or stroke.

      The range of motion (ROM) impairments associated with primary adhesive capsulitis can impact
      a patient's ability to participate in self-care and occupational activities. Even though this
      condition is considered self-limiting, with most patients having spontaneous resolution
      within 3 years, some patients can suffer long-term pain and restricted shoulder motion well
      beyond 3 years. A disability of this duration places severe emotional and economic hardship
      on the afflicted person. Most patients are unwilling to suffer this pain, prolonged
      disability, and sleep deprivation without seeking treatment.

      Currently, no standard medical, surgical, or therapy regimen is universally accepted as the
      most efficacious treatment for restoring motion in patients with shoulder adhesive
      capsulitis. While physical therapy is commonly prescribed for this condition, some studies
      have found little treatment benefit. Rehabilitation programs consisting of exercise, massage,
      and modalities have been shown to improve shoulder ROM in all planes except external and
      internal rotation. There is evidence, however, that joint mobilization procedures can lessen
      the associated gleno-humeral rotational deficits characteristic of this condition, especially
      external rotation. The optimal direction of force and movement application for the joint
      mobilization to restore external rotation, however, is not clear. Traditionally, physical
      therapists have used an anterior glide of the humeral head on the glenoid technique to
      improve external rotation ROM, a choice based on the "convex-on-concave" concept of joint
      surface motion. In contrast, Roubal et al used a posteriorly directed glide manipulation
      based on the "capsular constraint mechanism" to restore external as well as internal rotation
      ROM.Supra-scapular nerve block (SSNB) is a safe and effective method to treat pain in chronic
      diseases that affect the shoulder. The technique consists of injecting anaesthetics in
      supraspinatus fossa of affected shoulder, with the patient sitting down and upper limbs
      pending beside the body.The technique consists of injecting anesthetic in supraspinatus fossa
      of affected shoulder, with the patient sitting down and upper limbs pending beside the body.3
      In this study keltenborn joint mobilization will be use as intervention is to restore the
      joint play and in order to normalize the rolling and gliding of any joint, which are
      necessary for the active normal and non-painful movement. Some general exercises also help us
      to treat adhesive capsulitis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental
primary purpose: Other
masking: Single (Participant)
measure: Numeric Pain Rating Scale
time frame: change from baseline.This tool is used to measure pain intensity
description: NPRS) is a scale used to find the level of pain intensity. At the time of treatment session intensity of pain is mainly the center of attention of the treatment. This pain scale is used in routine in clinical setting during the application of treatment procedure to evaluate the intensity of pain. NPRS has good validity and reliability. In our study we evaluate the status of pain in shoulder in individuals with adhesive capsulitis. The NPRS is a segmented numeric version of the visual analog scale in which a respondent selects the whole number (0-10). '0' indicates no pain whereas '10' indicates extreme pain. In our study NPRS values are taken at base line, 7th visit and post visit
measure: Goniometer
time frame: change from baseline.This tool is used to measure shoulder ranges
description: In physical therapy goniometer is utilized to measures range of movement joint angles in the body.
measure: SHOULDER PAIN AND DISABILITY INDEX (SPADI)
time frame: change from baseline.This tool is used to measure shoulder disability
description: By using this tool we can access pain as well as level of disability of patient having frozen shoulder. This tool consists of 13 questions. A therapist asked questions to patients. It takes 5 to 10 minutes to finish the questionnaire n marked accordingly. SPADI values were taken at baseline, 7th visit and post visit
arm group label: Shoulder mobilization Group
arm group type: Experimental
description: Kaltenborn mobilization will be applied to patient in experimental group only.
arm group label: Conventional treatment Group
arm group type: Active Comparator
description: Application of conventional treatment that includes stretching and strengthening exercises of shoulder.
intervention type: Other
intervention name: Shoulder mobilization Group
description: Suprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps)
arm group label: Shoulder mobilization Group
intervention type: Other
intervention name: Conventional Treatment Group
description: Suprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps)
arm group label: Conventional treatment Group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: imran Amjad, phd*
role: Principal Investigator
affiliation: Associate Professor
facility: 
facility: 
country: Pakistan
citation: Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.
PMID: 18475240
citation: Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PMID: 16282408
citation: Cho CH, Song KS, Kim BS, Kim DH, Lho YM. Biological Aspect of Pathophysiology for Frozen Shoulder. Biomed Res Int. 2018 May 24;2018:7274517. doi: 10.1155/2018/7274517. eCollection 2018.
PMID: 29992159
citation: Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.
PMID: 20110457
citation: Siegel LB, Cohen NJ, Gall EP. Adhesive capsulitis: a sticky issue. Am Fam Physician. 1999 Apr 1;59(7):1843-52.
PMID: 10208704
citation: Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
PMID: 16356983
citation: Baums MH, Spahn G, Nozaki M, Steckel H, Schultz W, Klinger HM. Functional outcome and general health status in patients after arthroscopic release in adhesive capsulitis. Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):638-44. doi: 10.1007/s00167-006-0203-x. Epub 2006 Oct 10. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2007 May;15(5):687.
PMID: 17031613
responsible party type: Sponsor
mesh term: Bursitis
sharing ipd: No