<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/NCT03303001</url>
  </required_header>
  <id_info>
    <org_study_id>OR17-00006</org_study_id>
    <nct_id>NCT03303001</nct_id>
  </id_info>
  <brief_title>Comparison Between Subacromial Infiltrations</brief_title>
  <official_title>Subacromial Injection of High Volume Versus Conventional Steroid Injection Guided by Ultrasound in Shoulder Pain. Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Nuevo Leon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Nuevo Leon</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected&#xD;
      in activities of daily living and in laborer absent. One of the first treatment lines is the&#xD;
      steroid infiltration for pain relieve, however in several times is only effective by a short&#xD;
      period of time, and the symptoms usually appear again. One of the not known infiltration is&#xD;
      the high volumen infiltration in subacromial space, this treatment appears to be an effective&#xD;
      treatment for this patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain is a common complaint in patients of all ages and activity levels, it is&#xD;
      estimated that approximately 50% of the general population will experience at least one&#xD;
      episode of shoulder pain over the course of a year. Shoulder pain has a general prevalence of&#xD;
      6.9-34%. The shoulder is the part of the upper extremity which is formed the proximal&#xD;
      humerus, by the clavicle and the scapula, consisting in the shoulder griddle. The acromion is&#xD;
      a bony process in the upper region of the scapula that articulates medially with the clavicle&#xD;
      creating the acromioclavicular joint, at the same time forms the upper part of the shoulder&#xD;
      joint. Between the humeral head and the acromion arch there is a space, the subacromial&#xD;
      space, in which there are important structures for the proper functioning of the shoulder,&#xD;
      among them, the subacromial bursa, the tendon of the rotator cuff and the tendon of the&#xD;
      biceps brachii. The shoulder is the most mobile joint of all the body, therefore it is&#xD;
      predisposed to suffer multiple injuries, including shoulder impingement syndrome, which has&#xD;
      become one of the most frequent alterations of the musculoskeletal system. This pathology has&#xD;
      an estimated prevalence of 43.7%. It is one of the most common causes of shoulder pain in the&#xD;
      middle and advanced age patients.&#xD;
&#xD;
      Shoulder Impingement Syndrome is a condition in which structures in the subacromial space are&#xD;
      chronically trapped between the humeral head and the acromion. It encompasses multiple&#xD;
      conditions which includes partial rupture of the rotator cuff, rotator cuff tendinosis,&#xD;
      calcified tendinitis or subacromial bursitis. All of these conditions may have a similar&#xD;
      clinical picture and may be distinguishable by imaging of arthroscopy. The etiology of the&#xD;
      syndrome is multifactorial, divided into extrinsic factors such as tendon overload, post&#xD;
      trauma or repetitive microtraumas and intrinsic factors such as the vascularity of the&#xD;
      tendon. There are also structural factors: anatomy of the acromion, subacromial osteophytes&#xD;
      and acromioclavicular osteophytes; and functional factors: weakness of the rotator cuff,&#xD;
      altered movement of scapula and ligament laxity increased. It is the result of a reduced&#xD;
      space below the acromion. The most frequent clinical presentation will be insidious pain that&#xD;
      can be installed in a period of days to months or after a trauma that can be irradiated to&#xD;
      the side of the humerus. Usually the pain is nocturnal exacerbated by movements above the&#xD;
      head or sleep on the affected shoulder and is attenuated by keeping the affected limb at&#xD;
      rest.&#xD;
&#xD;
      Physical examination should assess muscular strength and ranges of motion. The general&#xD;
      inspection should assess the presence of antalgic positions, muscular atrophy, asymmetries or&#xD;
      sings of local inflammation. There is specific evidence for the evaluation of this pathology:&#xD;
      Jobe's test, to evaluate de supraspinatus muscle, in which the patient is asked to perform&#xD;
      90° shoulder flexion, 30° abduction and external rotation and maintain the position against&#xD;
      the shoulder resistance; Hawkins-Kennedy sign, for the subacromial impingement evaluation,&#xD;
      with shoulder and elbow with 90° flexion perform rapid internal rotation of the shoulder, it&#xD;
      is positive if it arouses with pain; Neer maneuver, for assessment of subacromial&#xD;
      impingement, consists of the passive elevation of the extremity in abduction, flexion and&#xD;
      internal rotation with stabilization of the scapula; Yocum´s maneuver, for assessment of&#xD;
      subacromial impingement, the patient is asked to place the hand of the explored side in the&#xD;
      contralateral shoulder and rises against resistance, it is positive if it causes pain. There&#xD;
      are multiple differential diagnoses of this pathology, among which is adhesive capsulitis,&#xD;
      cervical radiculopathy, glenohumeral instability, and acromioclavicular or glenohumeral&#xD;
      osteoarthritis, among others.&#xD;
&#xD;
      The diagnosis is clinical and it is corroborated by imaging studies. Shoulder radiographs&#xD;
      should be ordered in two positions to assess the morphology of the shoulder joint, to observe&#xD;
      the distance between the humeral head to the acromion (11-14mm) and the evaluation of the&#xD;
      acromioclavicular joint. Magnetic resonance imaging is the study of choice for evaluating&#xD;
      shoulder impingement syndrome, where we will observe soft tissue structures that are part of&#xD;
      the shoulder joint. Shoulder Impingement Syndrome is a pathology that causes pain and&#xD;
      limitations to perform activities of daily living and evidence suggests that this condition&#xD;
      is no self-limited, for this there are different alternatives of treatment. The aim of&#xD;
      treatment is to decrease the pain and inflammation of soft tissues involved in the&#xD;
      impingement in the subacromial space. Conservative treatment includes physical therapy,&#xD;
      non-steroidal anti-inflammatory analgesics (NSAIDs) and subacromial infiltration. Surgical&#xD;
      treatment includes shoulder arthroscopy to perform acromioplasty and thus release the&#xD;
      subacromial space&#xD;
&#xD;
      Conservative Treatment&#xD;
&#xD;
      Physical Therapy Physical therapy is frequently implemented to reduce pain and improve&#xD;
      shoulder function in this pathology. This must be carried out for at least six weeks. It&#xD;
      includes cold-heat therapy, ultrasound, which has been shown to be of no benefit in the&#xD;
      treatment of shoulder impingement and structural shoulder exercises, the aim of these&#xD;
      treatment Is to reduce subacromial mechanical stress, to improve movement patterns and&#xD;
      strengthening muscle fibers and thus prevent relapses, which have shown improvement in pain&#xD;
      and function. Added to this it is recommended to avoid activities that are carried out above&#xD;
      the head until the symptoms decrease.&#xD;
&#xD;
      Non-steroidal anti-inflammatory analgesics It is a frequent therapy in the treatment of this&#xD;
      pathology. The effectiveness of NSAIDs in the treatment of shoulder impingement has not been&#xD;
      demonstrated and potential complications have been observed with the use of long-term NSAIDs.&#xD;
&#xD;
      Shoulder Subacromial Injection It is a technique that consists of the direct application of&#xD;
      an active principle in the subacromial space with the objective to suppress the inflammation&#xD;
      and to diminish the pain. There are studies that show that there is a variation in the type&#xD;
      and dose of steroids used in infiltration, in addition to that the number infiltrations also&#xD;
      varied. Two studies conclude that there is an improvement in pain and range of motion with&#xD;
      the use of this treatment.&#xD;
&#xD;
      Surgical Treatment Surgical treatment is indicated in patients who fail conservative&#xD;
      treatment and continuous pain or in patients with complete rupture of the rotator cuff.&#xD;
      Actually subacromial decompression with acromioplasty, osteophyte resection and bursectomy is&#xD;
      performed by arthroscopy, in addition, to being able to observe the possible damage to the&#xD;
      tendon of the rotator cuff, which, if present, can be repaired. It is currently mentioned&#xD;
      that there is limited benefit with the conservative treatment established in the impingement&#xD;
      syndrome, which is why new treatment options are being developed. A new treatment option is&#xD;
      ultrasound-guided high-volume injection (HVIGI) in patients with shoulder impingement&#xD;
      syndrome. Ultrasound-guided high-volume injection is a recent technique that involves&#xD;
      injecting a high volume of fluid including a long-acting anesthetic and corticosteroids,&#xD;
      guided by imaging (ultrasound). This technique has been used successfully and with good&#xD;
      results in patellar tendinopathies, Achilles tendinopathies and subacromial impingement. High&#xD;
      volume injection acts in different ways: breaks adhesions, stripping effect, stretch, has&#xD;
      compression effect and also removes pain and promotes the healing of tendinopathy. Each&#xD;
      injected component has different effect: the high volume breaks the adhesions, stretch and&#xD;
      has drag effect; the long-acting anesthetic removes pain and the steroid prevents the&#xD;
      formation of adhesions and promotes tendon healing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 2020</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>Three months</time_frame>
    <description>Measure the pain in patient, when 0 is no pain and 10 worst pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Three months</time_frame>
    <description>Evaluates pain and function in 13 questions, with a scale from 0 to 10, normal shoulder is 0 and worst is 130</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simple Shoulder Test (SST)</measure>
    <time_frame>Three months</time_frame>
    <description>Twelve questions based on pain, function and range of motion, when 0 is an affected shoulder and 12 in a normal shoulder</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Subacromial Bursitis</condition>
  <condition>Subacromial Impingement Syndrome</condition>
  <condition>Rotator Cuff Impingement Syndrome</condition>
  <arm_group>
    <arm_group_label>Subacromial high volume infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received an subacromial infiltration guided by ultrasound, of 50 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 8 mL of lidocaine simple plus 10 mL of ropivacaine 7.5% plus 30 mL of saline solution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subacromial conventional infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received an subacromial infiltration guided by ultrasound of 10 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 3 mL of lidocaine simple plus 5 mL of ropivacaine 7.5%</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subacromial high volume infiltration</intervention_name>
    <description>This group will receive a high volume dose of a mix of methylprednisolone (40 mg in 2 mL) plus ropivacaine at 7.5% plus simple lidocaine plus saline solution for a total of 50 mL</description>
    <arm_group_label>Subacromial high volume infiltration</arm_group_label>
    <other_name>subacromial infiltration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subacromial conventional infiltration</intervention_name>
    <description>This group will receive a mix of solution of 2 mL of 40 mg of methylprednisolone plus 5 ml of ropivacaine at 7.5% plus 3 mL of lidocaine simple for a total of 10 ml</description>
    <arm_group_label>Subacromial conventional infiltration</arm_group_label>
    <other_name>subacromial infiltration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Shoulder impingement syndrome&#xD;
&#xD;
          -  Three months of history of pain and disability of the shoulder&#xD;
&#xD;
          -  Failure to conservative initial treatment with NSAID's and rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rotator cuff tears&#xD;
&#xD;
          -  Previous shoulder surgeries of any kind&#xD;
&#xD;
          -  Glenohumeral or acromioclavicular arthritis&#xD;
&#xD;
          -  Metabolic disease like diabetes mellitus or rheumatoid arthritis&#xD;
&#xD;
          -  Previous infiltration in the past sixth months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos Acosta-Olivo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Autonoma de Nuevo Leon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidad Autonoma de Nuevo Leon</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64480</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Autonoma de Nuevo Leon</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>66460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <results_reference>
    <citation>Morton S, Chan O, Ghozlan A, Price J, Perry J, Morrissey D. High volume image guided injections and structured rehabilitation in shoulder impingement syndrome: a retrospective study. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):195-9. doi: 10.11138/mltj/2015.5.3.195. eCollection 2015 Jul-Sep.</citation>
    <PMID>26605194</PMID>
  </results_reference>
  <results_reference>
    <citation>Rossi F. Shoulder impingement syndromes. Eur J Radiol. 1998 May;27 Suppl 1:S42-8. doi: 10.1016/s0720-048x(98)00042-4.</citation>
    <PMID>9652501</PMID>
  </results_reference>
  <results_reference>
    <citation>Koester MC, George MS, Kuhn JE. Shoulder impingement syndrome. Am J Med. 2005 May;118(5):452-5. doi: 10.1016/j.amjmed.2005.01.040.</citation>
    <PMID>15866244</PMID>
  </results_reference>
  <results_reference>
    <citation>Chard MD, Sattelle LM, Hazleman BL. The long-term outcome of rotator cuff tendinitis--a review study. Br J Rheumatol. 1988 Oct;27(5):385-9. doi: 10.1093/rheumatology/27.5.385.</citation>
    <PMID>3179628</PMID>
  </results_reference>
  <results_reference>
    <citation>Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.</citation>
    <PMID>12804509</PMID>
  </results_reference>
  <results_reference>
    <citation>Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.</citation>
    <PMID>12535501</PMID>
  </results_reference>
  <results_reference>
    <citation>Petri M, Dobrow R, Neiman R, Whiting-O'Keefe Q, Seaman WE. Randomized, double-blind, placebo-controlled study of the treatment of the painful shoulder. Arthritis Rheum. 1987 Sep;30(9):1040-5. doi: 10.1002/art.1780300911.</citation>
    <PMID>3311051</PMID>
  </results_reference>
  <results_reference>
    <citation>Wheeler PC, Mahadevan D, Bhatt R, Bhatia M. A Comparison of Two Different High-Volume Image-Guided Injection Procedures for Patients With Chronic Noninsertional Achilles Tendinopathy: A Pragmatic Retrospective Cohort Study. J Foot Ankle Surg. 2016 Sep-Oct;55(5):976-9. doi: 10.1053/j.jfas.2016.04.017. Epub 2016 Jun 7.</citation>
    <PMID>27286927</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 1, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>January 30, 2021</last_update_submitted>
  <last_update_submitted_qc>January 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Nuevo Leon</investigator_affiliation>
    <investigator_full_name>Carlos A Acosta-Olivo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>subacromial infiltration</keyword>
  <keyword>high volumen</keyword>
  <keyword>shoulder pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Bursitis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Actually is an active study</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/NCT03303001
org study id: OR17-00006
nct id: NCT03303001
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected
      in activities of daily living and in laborer absent. One of the first treatment lines is the
      steroid infiltration for pain relieve, however in several times is only effective by a short
      period of time, and the symptoms usually appear again. One of the not known infiltration is
      the high volumen infiltration in subacromial space, this treatment appears to be an effective
      treatment for this patients.
Shoulder pain is a common complaint in patients of all ages and activity levels, it is
      estimated that approximately 50% of the general population will experience at least one
      episode of shoulder pain over the course of a year. Shoulder pain has a general prevalence of
      6.9-34%. The shoulder is the part of the upper extremity which is formed the proximal
      humerus, by the clavicle and the scapula, consisting in the shoulder griddle. The acromion is
      a bony process in the upper region of the scapula that articulates medially with the clavicle
      creating the acromioclavicular joint, at the same time forms the upper part of the shoulder
      joint. Between the humeral head and the acromion arch there is a space, the subacromial
      space, in which there are important structures for the proper functioning of the shoulder,
      among them, the subacromial bursa, the tendon of the rotator cuff and the tendon of the
      biceps brachii. The shoulder is the most mobile joint of all the body, therefore it is
      predisposed to suffer multiple injuries, including shoulder impingement syndrome, which has
      become one of the most frequent alterations of the musculoskeletal system. This pathology has
      an estimated prevalence of 43.7%. It is one of the most common causes of shoulder pain in the
      middle and advanced age patients.

      Shoulder Impingement Syndrome is a condition in which structures in the subacromial space are
      chronically trapped between the humeral head and the acromion. It encompasses multiple
      conditions which includes partial rupture of the rotator cuff, rotator cuff tendinosis,
      calcified tendinitis or subacromial bursitis. All of these conditions may have a similar
      clinical picture and may be distinguishable by imaging of arthroscopy. The etiology of the
      syndrome is multifactorial, divided into extrinsic factors such as tendon overload, post
      trauma or repetitive microtraumas and intrinsic factors such as the vascularity of the
      tendon. There are also structural factors: anatomy of the acromion, subacromial osteophytes
      and acromioclavicular osteophytes; and functional factors: weakness of the rotator cuff,
      altered movement of scapula and ligament laxity increased. It is the result of a reduced
      space below the acromion. The most frequent clinical presentation will be insidious pain that
      can be installed in a period of days to months or after a trauma that can be irradiated to
      the side of the humerus. Usually the pain is nocturnal exacerbated by movements above the
      head or sleep on the affected shoulder and is attenuated by keeping the affected limb at
      rest.

      Physical examination should assess muscular strength and ranges of motion. The general
      inspection should assess the presence of antalgic positions, muscular atrophy, asymmetries or
      sings of local inflammation. There is specific evidence for the evaluation of this pathology:
      Jobe's test, to evaluate de supraspinatus muscle, in which the patient is asked to perform
      90° shoulder flexion, 30° abduction and external rotation and maintain the position against
      the shoulder resistance; Hawkins-Kennedy sign, for the subacromial impingement evaluation,
      with shoulder and elbow with 90° flexion perform rapid internal rotation of the shoulder, it
      is positive if it arouses with pain; Neer maneuver, for assessment of subacromial
      impingement, consists of the passive elevation of the extremity in abduction, flexion and
      internal rotation with stabilization of the scapula; Yocum´s maneuver, for assessment of
      subacromial impingement, the patient is asked to place the hand of the explored side in the
      contralateral shoulder and rises against resistance, it is positive if it causes pain. There
      are multiple differential diagnoses of this pathology, among which is adhesive capsulitis,
      cervical radiculopathy, glenohumeral instability, and acromioclavicular or glenohumeral
      osteoarthritis, among others.

      The diagnosis is clinical and it is corroborated by imaging studies. Shoulder radiographs
      should be ordered in two positions to assess the morphology of the shoulder joint, to observe
      the distance between the humeral head to the acromion (11-14mm) and the evaluation of the
      acromioclavicular joint. Magnetic resonance imaging is the study of choice for evaluating
      shoulder impingement syndrome, where we will observe soft tissue structures that are part of
      the shoulder joint. Shoulder Impingement Syndrome is a pathology that causes pain and
      limitations to perform activities of daily living and evidence suggests that this condition
      is no self-limited, for this there are different alternatives of treatment. The aim of
      treatment is to decrease the pain and inflammation of soft tissues involved in the
      impingement in the subacromial space. Conservative treatment includes physical therapy,
      non-steroidal anti-inflammatory analgesics (NSAIDs) and subacromial infiltration. Surgical
      treatment includes shoulder arthroscopy to perform acromioplasty and thus release the
      subacromial space

      Conservative Treatment

      Physical Therapy Physical therapy is frequently implemented to reduce pain and improve
      shoulder function in this pathology. This must be carried out for at least six weeks. It
      includes cold-heat therapy, ultrasound, which has been shown to be of no benefit in the
      treatment of shoulder impingement and structural shoulder exercises, the aim of these
      treatment Is to reduce subacromial mechanical stress, to improve movement patterns and
      strengthening muscle fibers and thus prevent relapses, which have shown improvement in pain
      and function. Added to this it is recommended to avoid activities that are carried out above
      the head until the symptoms decrease.

      Non-steroidal anti-inflammatory analgesics It is a frequent therapy in the treatment of this
      pathology. The effectiveness of NSAIDs in the treatment of shoulder impingement has not been
      demonstrated and potential complications have been observed with the use of long-term NSAIDs.

      Shoulder Subacromial Injection It is a technique that consists of the direct application of
      an active principle in the subacromial space with the objective to suppress the inflammation
      and to diminish the pain. There are studies that show that there is a variation in the type
      and dose of steroids used in infiltration, in addition to that the number infiltrations also
      varied. Two studies conclude that there is an improvement in pain and range of motion with
      the use of this treatment.

      Surgical Treatment Surgical treatment is indicated in patients who fail conservative
      treatment and continuous pain or in patients with complete rupture of the rotator cuff.
      Actually subacromial decompression with acromioplasty, osteophyte resection and bursectomy is
      performed by arthroscopy, in addition, to being able to observe the possible damage to the
      tendon of the rotator cuff, which, if present, can be repaired. It is currently mentioned
      that there is limited benefit with the conservative treatment established in the impingement
      syndrome, which is why new treatment options are being developed. A new treatment option is
      ultrasound-guided high-volume injection (HVIGI) in patients with shoulder impingement
      syndrome. Ultrasound-guided high-volume injection is a recent technique that involves
      injecting a high volume of fluid including a long-acting anesthetic and corticosteroids,
      guided by imaging (ultrasound). This technique has been used successfully and with good
      results in patellar tendinopathies, Achilles tendinopathies and subacromial impingement. High
      volume injection acts in different ways: breaks adhesions, stripping effect, stretch, has
      compression effect and also removes pain and promotes the healing of tendinopathy. Each
      injected component has different effect: the high volume breaks the adhesions, stretch and
      has drag effect; the long-acting anesthetic removes pain and the steroid prevents the
      formation of adhesions and promotes tendon healing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Visual Analogue Scale
time frame: Three months
description: Measure the pain in patient, when 0 is no pain and 10 worst pain
measure: Shoulder Pain and Disability Index (SPADI)
time frame: Three months
description: Evaluates pain and function in 13 questions, with a scale from 0 to 10, normal shoulder is 0 and worst is 130
measure: Simple Shoulder Test (SST)
time frame: Three months
description: Twelve questions based on pain, function and range of motion, when 0 is an affected shoulder and 12 in a normal shoulder
arm group label: Subacromial high volume infiltration
arm group type: Experimental
description: This group received an subacromial infiltration guided by ultrasound, of 50 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 8 mL of lidocaine simple plus 10 mL of ropivacaine 7.5% plus 30 mL of saline solution.
arm group label: Subacromial conventional infiltration
arm group type: Active Comparator
description: This group received an subacromial infiltration guided by ultrasound of 10 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 3 mL of lidocaine simple plus 5 mL of ropivacaine 7.5%
intervention type: Procedure
intervention name: Subacromial high volume infiltration
description: This group will receive a high volume dose of a mix of methylprednisolone (40 mg in 2 mL) plus ropivacaine at 7.5% plus simple lidocaine plus saline solution for a total of 50 mL
arm group label: Subacromial high volume infiltration
other name: subacromial infiltration
intervention type: Procedure
intervention name: Subacromial conventional infiltration
description: This group will receive a mix of solution of 2 mL of 40 mg of methylprednisolone plus 5 ml of ropivacaine at 7.5% plus 3 mL of lidocaine simple for a total of 10 ml
arm group label: Subacromial conventional infiltration
other name: subacromial infiltration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Carlos Acosta-Olivo, MD, PhD
role: Principal Investigator
affiliation: Universidad Autonoma de Nuevo Leon
facility: 
facility: 
country: Mexico
citation: Morton S, Chan O, Ghozlan A, Price J, Perry J, Morrissey D. High volume image guided injections and structured rehabilitation in shoulder impingement syndrome: a retrospective study. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):195-9. doi: 10.11138/mltj/2015.5.3.195. eCollection 2015 Jul-Sep.
PMID: 26605194
citation: Rossi F. Shoulder impingement syndromes. Eur J Radiol. 1998 May;27 Suppl 1:S42-8. doi: 10.1016/s0720-048x(98)00042-4.
PMID: 9652501
citation: Koester MC, George MS, Kuhn JE. Shoulder impingement syndrome. Am J Med. 2005 May;118(5):452-5. doi: 10.1016/j.amjmed.2005.01.040.
PMID: 15866244
citation: Chard MD, Sattelle LM, Hazleman BL. The long-term outcome of rotator cuff tendinitis--a review study. Br J Rheumatol. 1988 Oct;27(5):385-9. doi: 10.1093/rheumatology/27.5.385.
PMID: 3179628
citation: Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.
PMID: 12804509
citation: Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.
PMID: 12535501
citation: Petri M, Dobrow R, Neiman R, Whiting-O'Keefe Q, Seaman WE. Randomized, double-blind, placebo-controlled study of the treatment of the painful shoulder. Arthritis Rheum. 1987 Sep;30(9):1040-5. doi: 10.1002/art.1780300911.
PMID: 3311051
citation: Wheeler PC, Mahadevan D, Bhatt R, Bhatia M. A Comparison of Two Different High-Volume Image-Guided Injection Procedures for Patients With Chronic Noninsertional Achilles Tendinopathy: A Pragmatic Retrospective Cohort Study. J Foot Ankle Surg. 2016 Sep-Oct;55(5):976-9. doi: 10.1053/j.jfas.2016.04.017. Epub 2016 Jun 7.
PMID: 27286927
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Nuevo Leon
investigator full name: Carlos A Acosta-Olivo
investigator title: Professor
mesh term: Shoulder Impingement Syndrome
mesh term: Bursitis
mesh term: Syndrome
mesh term: Rotator Cuff Injuries
sharing ipd: Undecided
ipd description: Actually is an active study