<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/NCT03815669</url>
  </required_header>
  <id_info>
    <org_study_id>LSskulder</org_study_id>
    <nct_id>NCT03815669</nct_id>
  </id_info>
  <brief_title>Improving Quality of Treatment for Shoulder Patients</brief_title>
  <official_title>Improving Quality of Treatment for Shoulder Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction:&#xD;
&#xD;
      Previous studies indicate that patient characteristics and clinical and psychological factors&#xD;
      are related to the effect of surgical treatment but more knowledge about predictors is&#xD;
      important in the selection of patients for arthroscopic subacromial decompression.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To identify patient characteristics and clinical and psychological factors for&#xD;
      pre-operatively predicting the effect of arthroscopic subacromial decompression.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Patients meting the inclusion criteria will consecutively be enrolled in the study when&#xD;
      referred to arthroscopic subacromial decompression. Prior to surgery, patient characteristics&#xD;
      and clinical data will be collected. At six and twelve month postoperatively, the effect of&#xD;
      the surgical treatment will be assessed. The relationship between effect of surgery and&#xD;
      patient characteristics and clinical factors collected at baseline will be examined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Shoulder disorders are the third most common musculoskeletal reason for seeking&#xD;
      medical care and accounts for approximately 1% of all visits to the general practitioner and&#xD;
      for up to 10% of all referrals to physiotherapists. The prevalence of shoulder disorders has&#xD;
      been reported to range from 7% to 26% with some indication that the prevalence increases with&#xD;
      age. Subacromial impingement syndrome (SIS) is usually described as a symptomatic irritation&#xD;
      of the rotator cuff and the subacromial bursa, and it is considered as one of the most common&#xD;
      shoulder disorders. Patients with SIS may present symptoms such as pain during activity, pain&#xD;
      at night, loss of muscle strength, and stiffness. Because the shoulder stabilizes the upper&#xD;
      limb in its activities, these symptoms affect the performance of tasks essential to daily&#xD;
      living. Shoulder disorders produce significant impairments in function and health related&#xD;
      quality of life (HR-QoL), and results in substantial health care utilization. SIS frequently&#xD;
      affects the working population and is an important cause of sick leave.&#xD;
&#xD;
      Treatment of SIS consists of either conservative- or surgical treatment. Conservative&#xD;
      treatments include rest, physiotherapy, non-steroid anti inflammatory drugs (NSAID) and&#xD;
      glucocorticoid injections, while surgical treatment consists of arthroscopic or open&#xD;
      subacromial decompression, bursectomy and rotator cuff repair. Physiotherapy interventions&#xD;
      are recommended as first choice of treatment, while surgical treatment can be considered for&#xD;
      those who fail to respond to conservative treatment after 3-6 months. Several studies&#xD;
      comparing the effect of arthroscopic subacromial decompression (ASAD) and supervised&#xD;
      physiotherapy exercises, have found no significant differences in outcomes between the two&#xD;
      treatment strategies.&#xD;
&#xD;
      In Denmark, the number of patients with SIS has increased by 36% from 2006 to 2010. The&#xD;
      number of patients treated surgically has increased by 60% to approximately 6500 a year in&#xD;
      the same period. Similar increases are reported in other countries.&#xD;
&#xD;
      The literature indicates that some patients do not benefit from ASAD, and success rates&#xD;
      between 65-80% have been reported. In Denmark, 10% of employed patients retire prematurely&#xD;
      within two years after surgery. Results of studies investigating if ASAD is more effective in&#xD;
      selected subgroups of patients showed that clinical and radiological factors and patient&#xD;
      characteristics such as sociodemographic, duration of symptoms and duration of sick leave,&#xD;
      were associated with the effect of treatment. In addition, psychological factors are reported&#xD;
      to impact outcome in both shoulder patients, and other orthopaedic patients. A preoperative&#xD;
      scoring system to select patients for ASAD has been developed. However, this focuses on&#xD;
      clinical and radiographic factors, and does not consider patient characteristics and&#xD;
      psychological factors. Knowledge about predictors for the effect of ASAD in a broader&#xD;
      perspective will be of great importance, from both a patient- and an economic perspective.&#xD;
&#xD;
      Aim: The overall aim of the study is to identify patient characteristic and clinical and&#xD;
      psychological factors that preoperatively can predict which patients will achieve effect of&#xD;
      ASAD. Furthermore, to investigate the quality of objective methods to assess shoulder&#xD;
      function, and the association between patient reported outcome measures (PROMs) and objective&#xD;
      outcome measures.&#xD;
&#xD;
      Power considerations: Based on data extracted from the Central Denmark Region Electronic&#xD;
      Patient Journal (Mid EPJ) an estimation of 150 patients annually undergo ASAD at Aarhus&#xD;
      University Hospital. With a planned inclusion period of two years and a drop out rate of 10%,&#xD;
      it means that 270 patients will be included. Using an estimate of 20% it is expected that 54&#xD;
      out of 270 patients will not benefit from ASAD. The number of patients without the effect of&#xD;
      ASAD will affect the number of potential predictors that can be analyzed.&#xD;
&#xD;
      Outcome assessment: Effect of surgical treatment will be assessed with two instruments: 1)&#xD;
      patient evaluated success of treatment with the response options: much improved, moderate&#xD;
      improved, unchanged, moderate worse, and much worse and 2) the Oxford Shoulder Score (OSS).&#xD;
      Effect of surgical treatment will be defined as a much - or moderate improvement evaluated by&#xD;
      the patient, or an improvement of more than 12 points in OSS between baseline and follow-up.&#xD;
      The 12 point criterion is previous used to develop a preoperative scoring system to select&#xD;
      patients for ASAD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to covid 19, it has not been possible to recruit enough participants to complete the study.&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment effect</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain self-efficacy</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain self-efficacy</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear-Avoidance beliefs</measure>
    <time_frame>Baseline</time_frame>
    <description>Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear-Avoidance beliefs</measure>
    <time_frame>12 month postoperatively</time_frame>
    <description>Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain, VAS</measure>
    <time_frame>Baseline</time_frame>
    <description>Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain, VAS</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Baseline</time_frame>
    <description>Internal and external rotation, abduction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Internal and external rotation, abduction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion (ROM)</measure>
    <time_frame>Baseline</time_frame>
    <description>Internal and external rotation, abduction and flexion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion (ROM)</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Internal and external rotation, abduction and flexion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor and process skills</measure>
    <time_frame>Baseline</time_frame>
    <description>The Assessment of Motor and Process Skills (AMPS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motor and process skills</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>The Assessment of Motor and Process Skills (AMPS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Return to work</measure>
    <time_frame>Baseline</time_frame>
    <description>Duration of sick leave</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comorbidity</measure>
    <time_frame>Baseline</time_frame>
    <description>Charlson comorbidity index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment effect</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain self-efficacy</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear-Avoidance beliefs</measure>
    <time_frame>6 month postoperatively</time_frame>
    <description>Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">58</enrollment>
  <condition>Arthroscopic Subacromial Decompression</condition>
  <arm_group>
    <arm_group_label>Arthroscopic subacromial decompression</arm_group_label>
    <description>Patients referred to arthroscopic subacromial decompression</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arthroscopic subacromial decompression</intervention_name>
    <description>Arthroscopic subacromial decompression</description>
    <arm_group_label>Arthroscopic subacromial decompression</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients from Department of Orthopaedic Surgery, Aarhus University Hospital, Denmark&#xD;
        will consecutively be invited to participate in the study when they are referred to&#xD;
        arthroscopic subacromial decompression.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  treated with arthroscopic subacromial decompression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frozen shoulder, full-thickness tear, osteoarthritis, trauma, cancer or neurologic&#xD;
             disorders&#xD;
&#xD;
          -  Previous surgical treatment in the affected shoulder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annemette Krintel Petersen, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Dept. of Clinical Medicine, Aaarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Orthopaedic Surgery and dept. of Physiotherapy and Occupational Therapy, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arthroscopic subacromial decompression</keyword>
  <keyword>shoulder impingement syndrome</keyword>
  <keyword>effect</keyword>
  <keyword>surgery</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03815669
org study id: LSskulder
nct id: NCT03815669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Previous studies indicate that patient characteristics and clinical and psychological factors
      are related to the effect of surgical treatment but more knowledge about predictors is
      important in the selection of patients for arthroscopic subacromial decompression.

      Objective:

      To identify patient characteristics and clinical and psychological factors for
      pre-operatively predicting the effect of arthroscopic subacromial decompression.

      Method:

      Patients meting the inclusion criteria will consecutively be enrolled in the study when
      referred to arthroscopic subacromial decompression. Prior to surgery, patient characteristics
      and clinical data will be collected. At six and twelve month postoperatively, the effect of
      the surgical treatment will be assessed. The relationship between effect of surgery and
      patient characteristics and clinical factors collected at baseline will be examined.
Introduction: Shoulder disorders are the third most common musculoskeletal reason for seeking
      medical care and accounts for approximately 1% of all visits to the general practitioner and
      for up to 10% of all referrals to physiotherapists. The prevalence of shoulder disorders has
      been reported to range from 7% to 26% with some indication that the prevalence increases with
      age. Subacromial impingement syndrome (SIS) is usually described as a symptomatic irritation
      of the rotator cuff and the subacromial bursa, and it is considered as one of the most common
      shoulder disorders. Patients with SIS may present symptoms such as pain during activity, pain
      at night, loss of muscle strength, and stiffness. Because the shoulder stabilizes the upper
      limb in its activities, these symptoms affect the performance of tasks essential to daily
      living. Shoulder disorders produce significant impairments in function and health related
      quality of life (HR-QoL), and results in substantial health care utilization. SIS frequently
      affects the working population and is an important cause of sick leave.

      Treatment of SIS consists of either conservative- or surgical treatment. Conservative
      treatments include rest, physiotherapy, non-steroid anti inflammatory drugs (NSAID) and
      glucocorticoid injections, while surgical treatment consists of arthroscopic or open
      subacromial decompression, bursectomy and rotator cuff repair. Physiotherapy interventions
      are recommended as first choice of treatment, while surgical treatment can be considered for
      those who fail to respond to conservative treatment after 3-6 months. Several studies
      comparing the effect of arthroscopic subacromial decompression (ASAD) and supervised
      physiotherapy exercises, have found no significant differences in outcomes between the two
      treatment strategies.

      In Denmark, the number of patients with SIS has increased by 36% from 2006 to 2010. The
      number of patients treated surgically has increased by 60% to approximately 6500 a year in
      the same period. Similar increases are reported in other countries.

      The literature indicates that some patients do not benefit from ASAD, and success rates
      between 65-80% have been reported. In Denmark, 10% of employed patients retire prematurely
      within two years after surgery. Results of studies investigating if ASAD is more effective in
      selected subgroups of patients showed that clinical and radiological factors and patient
      characteristics such as sociodemographic, duration of symptoms and duration of sick leave,
      were associated with the effect of treatment. In addition, psychological factors are reported
      to impact outcome in both shoulder patients, and other orthopaedic patients. A preoperative
      scoring system to select patients for ASAD has been developed. However, this focuses on
      clinical and radiographic factors, and does not consider patient characteristics and
      psychological factors. Knowledge about predictors for the effect of ASAD in a broader
      perspective will be of great importance, from both a patient- and an economic perspective.

      Aim: The overall aim of the study is to identify patient characteristic and clinical and
      psychological factors that preoperatively can predict which patients will achieve effect of
      ASAD. Furthermore, to investigate the quality of objective methods to assess shoulder
      function, and the association between patient reported outcome measures (PROMs) and objective
      outcome measures.

      Power considerations: Based on data extracted from the Central Denmark Region Electronic
      Patient Journal (Mid EPJ) an estimation of 150 patients annually undergo ASAD at Aarhus
      University Hospital. With a planned inclusion period of two years and a drop out rate of 10%,
      it means that 270 patients will be included. Using an estimate of 20% it is expected that 54
      out of 270 patients will not benefit from ASAD. The number of patients without the effect of
      ASAD will affect the number of potential predictors that can be analyzed.

      Outcome assessment: Effect of surgical treatment will be assessed with two instruments: 1)
      patient evaluated success of treatment with the response options: much improved, moderate
      improved, unchanged, moderate worse, and much worse and 2) the Oxford Shoulder Score (OSS).
      Effect of surgical treatment will be defined as a much - or moderate improvement evaluated by
      the patient, or an improvement of more than 12 points in OSS between baseline and follow-up.
      The 12 point criterion is previous used to develop a preoperative scoring system to select
      patients for ASAD.
observational model: Cohort
time perspective: Prospective
measure: Treatment effect
time frame: 12 month postoperatively
description: Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse
measure: Function
time frame: Baseline
description: Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome
measure: Function
time frame: 12 month postoperatively
description: Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome
measure: Pain self-efficacy
time frame: Baseline
description: Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy
measure: Pain self-efficacy
time frame: 12 month postoperatively
description: Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy
measure: Health related quality of life
time frame: Baseline
description: Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome
measure: Health related quality of life
time frame: 12 month postoperatively
description: Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome
measure: Anxiety and depression
time frame: Baseline
description: Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome
measure: Anxiety and depression
time frame: 12 month postoperatively
description: Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome
measure: Fear-Avoidance beliefs
time frame: Baseline
description: Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome
measure: Fear-Avoidance beliefs
time frame: 12 month postoperatively
description: Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome
measure: Pain, VAS
time frame: Baseline
description: Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome
measure: Pain, VAS
time frame: 6 month postoperatively
description: Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome
measure: Muscle strength
time frame: Baseline
description: Internal and external rotation, abduction
measure: Muscle strength
time frame: 6 month postoperatively
description: Internal and external rotation, abduction
measure: Range of motion (ROM)
time frame: Baseline
description: Internal and external rotation, abduction and flexion
measure: Range of motion (ROM)
time frame: 6 month postoperatively
description: Internal and external rotation, abduction and flexion
measure: Motor and process skills
time frame: Baseline
description: The Assessment of Motor and Process Skills (AMPS)
measure: Motor and process skills
time frame: 6 month postoperatively
description: The Assessment of Motor and Process Skills (AMPS)
measure: Return to work
time frame: Baseline
description: Duration of sick leave
measure: Comorbidity
time frame: Baseline
description: Charlson comorbidity index
measure: Treatment effect
time frame: 6 month postoperatively
description: Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse
measure: Function
time frame: 6 month postoperatively
description: Questionnaire, Oxford Shoulder Score (OSS) 12 questions, each rated on a 5 point Likert scale from 1 to 5, total sum score reported, minimum score 12, maximun score 60, higher scores represent worst outcome
measure: Pain self-efficacy
time frame: 6 month postoperatively
description: Questionnaire, Pain Self-Efficacy Questionnaire 10 questions, each question rated on a 7-point numeric rating scale from 0 to 6, total sum score reported, minimum score 0, maximun score 60, higher scores indicate greater self-efficacy
measure: Health related quality of life
time frame: 6 month postoperatively
description: Questionnaire, EQ-5D-5L 5 questions representing 5 dimentions, each question rated on a 5-point Likert scale from 1 to 5, higher scores indicate worse outcome, EQ VAS scale representing overall Health status, rated from 0 to 100, higher score indicate better outcome
measure: Anxiety and depression
time frame: 6 month postoperatively
description: Questionnaire, Hospital Anxiety and Depression Scale (HADS) 14 questions, 7 questions related to the subscale Anxiety, 7 questiion related to the subscale Depression, each question rated on a 4-point Likert scale from 0 to 3, total sum score for each subscale reported, higher scores indicate worse outcome
measure: Fear-Avoidance beliefs
time frame: 6 month postoperatively
description: Questionnaire, Fear-Avoidance Beliefs Questionnaire (FABQ) 16 items, 4 items related to the physical activity subscale, 7 items related to the Work subscale, 5 items not used in the scoring, each item rated on a 7-point Likert scale from 0 to 6, total sumscore for each subscale reported, minimum scores 0, maximum scores for the physical activity subscale 24, maximal score for the Work subscale 42, higher scores indicate worse outcome
arm group label: Arthroscopic subacromial decompression
description: Patients referred to arthroscopic subacromial decompression
intervention type: Procedure
intervention name: Arthroscopic subacromial decompression
description: Arthroscopic subacromial decompression
arm group label: Arthroscopic subacromial decompression
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annemette Krintel Petersen, Ph.D
role: Study Director
affiliation: Dept. of Clinical Medicine, Aaarhus University
facility: 
country: Denmark
responsible party type: Sponsor
sharing ipd: Undecided