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Improving Quality of Treatment for Shoulder Patients

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ClinicalTrials.gov Identifier: NCT03815669
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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.


Condition or disease Intervention/treatment
Arthroscopic Subacromial Decompression Procedure: Arthroscopic subacromial decompression

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Quality of Treatment for Shoulder Patients
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Group/Cohort Intervention/treatment
Arthroscopic subacromial decompression
Patients referred to arthroscopic subacromial decompression
Procedure: Arthroscopic subacromial decompression
Arthroscopic subacromial decompression




Primary Outcome Measures :
  1. Treatment effect [ Time Frame: 12 month postoperatively ]
    Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse

  2. Function [ Time Frame: Baseline ]
    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

  3. Function [ Time Frame: 12 month postoperatively ]
    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

  4. Pain self-efficacy [ Time Frame: Baseline ]
    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

  5. Pain self-efficacy [ Time Frame: 12 month postoperatively ]
    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

  6. Health related quality of life [ Time Frame: Baseline ]
    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

  7. Health related quality of life [ Time Frame: 12 month postoperatively ]
    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

  8. Anxiety and depression [ Time Frame: Baseline ]
    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

  9. Anxiety and depression [ Time Frame: 12 month postoperatively ]
    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

  10. Fear-Avoidance beliefs [ Time Frame: Baseline ]
    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

  11. Fear-Avoidance beliefs [ Time Frame: 12 month postoperatively ]
    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

  12. Pain, VAS [ Time Frame: Baseline ]
    Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome

  13. Pain, VAS [ Time Frame: 6 month postoperatively ]
    Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome

  14. Muscle strength [ Time Frame: Baseline ]
    Internal and external rotation, abduction

  15. Muscle strength [ Time Frame: 6 month postoperatively ]
    Internal and external rotation, abduction

  16. Range of motion (ROM) [ Time Frame: Baseline ]
    Internal and external rotation, abduction and flexion

  17. Range of motion (ROM) [ Time Frame: 6 month postoperatively ]
    Internal and external rotation, abduction and flexion

  18. Motor and process skills [ Time Frame: Baseline ]
    The Assessment of Motor and Process Skills (AMPS)

  19. Motor and process skills [ Time Frame: 6 month postoperatively ]
    The Assessment of Motor and Process Skills (AMPS)

  20. Return to work [ Time Frame: Baseline ]
    Duration of sick leave

  21. Comorbidity [ Time Frame: Baseline ]
    Charlson comorbidity index


Secondary Outcome Measures :
  1. Treatment effect [ Time Frame: 6 month postoperatively ]
    Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse

  2. Function [ Time Frame: 6 month postoperatively ]
    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

  3. Pain self-efficacy [ Time Frame: 6 month postoperatively ]
    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

  4. Health related quality of life [ Time Frame: 6 month postoperatively ]
    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

  5. Anxiety and depression [ Time Frame: 6 month postoperatively ]
    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

  6. Fear-Avoidance beliefs [ Time Frame: 6 month postoperatively ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients from Department of Orthopaedic Surgery, Aarhus University Hospital, Denmark will consecutively be invited to participate in the study when they are referred to arthroscopic subacromial decompression.
Criteria

Inclusion Criteria:

  • treated with arthroscopic subacromial decompression

Exclusion Criteria:

  • Frozen shoulder, full-thickness tear, osteoarthritis, trauma, cancer or neurologic disorders
  • Previous surgical treatment in the affected shoulder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815669


Contacts
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Contact: Lotte Sørensen, Phd stud. +45 78456705 lotte.soeresen@rm.dk

Locations
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Denmark
Dept of Orthopaedic Surgery and dept. of Physiotherapy and Occupational Therapy, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Lotte Sørensen, PhD stud.    +45 78456705    lotte.soerensen@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Annemette Krintel Petersen, Ph.D Dept. of Clinical Medicine, Aaarhus University

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03815669     History of Changes
Other Study ID Numbers: LSskulder
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
arthroscopic subacromial decompression
shoulder impingement syndrome
effect
surgery