Arthroscopic Subacromial DecompressionNCT03815669
Improving Quality of Treatment for Shoulder Patients
An observational study of Arthroscopic Subacromial Decompression, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Subacromial Decompression
- What is being tested?
- Arthroscopic subacromial decompression
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- treated with arthroscopic subacromial decompression
Who cannot join
- Frozen shoulder, full-thickness tear, osteoarthritis, trauma, cancer or neurologic disorders
- Previous surgical treatment in the affected shoulder
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept of Orthopaedic Surgery and dept. of Physiotherapy and Occupational Therapy, Aarhus University Hospital
Aarhus, 8200
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Arthroscopic Subacromial Decompression
- Being tested
- Arthroscopic subacromial decompression
- Keywords
- arthroscopic subacromial decompression, shoulder impingement syndrome, effect, surgery
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic subacromial decompressionProcedure or surgery
Arthroscopic subacromial decompression
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic subacromial decompression | Patients referred to arthroscopic subacromial decompression Receives: Procedure: Arthroscopic subacromial decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect
Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse
Measured: 12 month postoperatively
Function
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
Measured: Baseline
Function
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
Measured: 12 month postoperatively
Pain self-efficacy
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
Measured: Baseline
Pain self-efficacy
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
Measured: 12 month postoperatively
Health related quality of life
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
Measured: Baseline
Health related quality of life
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
Measured: 12 month postoperatively
Anxiety and depression
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
Measured: Baseline
Anxiety and depression
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
Measured: 12 month postoperatively
Fear-Avoidance beliefs
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
Measured: Baseline
Fear-Avoidance beliefs
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
Measured: 12 month postoperatively
Pain, VAS
Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome
Measured: Baseline
Pain, VAS
Pain at rest, activity and at night, Visual Analogue Scale (VAS) Scale rating form 0 to 10, higher score indicate worse outcome
Measured: 6 month postoperatively
Muscle strength
Internal and external rotation, abduction
Measured: Baseline
Muscle strength
Internal and external rotation, abduction
Measured: 6 month postoperatively
Range of motion (ROM)
Internal and external rotation, abduction and flexion
Measured: Baseline
Range of motion (ROM)
Internal and external rotation, abduction and flexion
Measured: 6 month postoperatively
Motor and process skills
The Assessment of Motor and Process Skills (AMPS)
Measured: Baseline
Motor and process skills
The Assessment of Motor and Process Skills (AMPS)
Measured: 6 month postoperatively
Return to work
Duration of sick leave
Measured: Baseline
Comorbidity
Charlson comorbidity index
Measured: Baseline
Secondary outcomes (6)
Treatment effect
Patient evaluated success of treatment, 5 point Likert scale, Posible answers: much improved, moderate improved, unchanged, moderate worse, much worse
Measured: 6 month postoperatively
Function
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
Measured: 6 month postoperatively
Pain self-efficacy
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
Measured: 6 month postoperatively
Health related quality of life
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
Measured: 6 month postoperatively
Anxiety and depression
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
Measured: 6 month postoperatively
Fear-Avoidance beliefs
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
Measured: 6 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jan 2019
- Primary completion20 Dec 2020
- Study completion31 Jan 2021
Why it stopped: Due to covid 19, it has not been possible to recruit enough participants to complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Subacromial DecompressionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemette Krintel Petersen, Ph.D, Study director, Dept. of Clinical Medicine, Aaarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815669
- Sponsor's protocol ID
- LSskulder
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Treatment for Shoulder Patients
- ClinicalTrials.gov ID
- NCT03815669
- Acronym / sponsor ID
- LSskulder
- Conditions
- Arthroscopic Subacromial Decompression
- Keywords
- arthroscopic subacromial decompression, shoulder impingement syndrome, effect, surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to covid 19, it has not been possible to recruit enough participants to complete the study.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic subacromial decompression | – | Procedure: Arthroscopic subacromial decompressionPatients referred to arthroscopic subacromial decompression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- treated with arthroscopic subacromial decompression
Key exclusion criteria (2 listed)
- Frozen shoulder, full-thickness tear, osteoarthritis, trauma, cancer or neurologic disorders
- Previous surgical treatment in the affected shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic subacromial decompressionArthroscopic subacromial decompression | Procedure or surgery | Arthroscopic subacromial decompression |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
Muscle strength
Time frame: Baseline
Internal and external rotation, abduction
Muscle strength
Time frame: 6 month postoperatively
Internal and external rotation, abduction
Range of motion (ROM)
Time frame: Baseline
Internal and external rotation, abduction and flexion
Range of motion (ROM)
Time frame: 6 month postoperatively
Internal and external rotation, abduction and flexion
Motor and process skills
Time frame: Baseline
The Assessment of Motor and Process Skills (AMPS)
Motor and process skills
Time frame: 6 month postoperatively
The Assessment of Motor and Process Skills (AMPS)
Return to work
Time frame: Baseline
Duration of sick leave
Comorbidity
Time frame: Baseline
Charlson comorbidity index
6 secondary outcomes
Treatment effect
Time frame: 6 month postoperatively
Function
Time frame: 6 month postoperatively
Pain self-efficacy
Time frame: 6 month postoperatively
Health related quality of life
Time frame: 6 month postoperatively
Anxiety and depression
Time frame: 6 month postoperatively
Fear-Avoidance beliefs
Time frame: 6 month postoperatively
Results and safety
The study was stopped early (reason given: Due to covid 19, it has not been possible to recruit enough participants to complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Arthroscopic Subacromial Decompression
Recruiting
The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemette Krintel Petersen, Ph.D study director
Dept. of Clinical Medicine, Aaarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopic Subacromial Decompression, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to covid 19, it has not been possible to recruit enough participants to complete the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect (time frame: 12 month postoperatively). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.