The Shoulder Intervention Project

Shoulder function and work disability after decompression surgery for subacromial impingement syndrome: a randomised controlled trial of physiotherapy exercises and occupational medical assistance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55768749

Enrollment

130

Registered

2010-11-03

Start date

2010-11-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder surgery Injury, Occupational Diseases, Poisoning Shoulder injury

Interventions

Current interventions as of 07/05/2014: The intervention period starts at randomisation approximately 10 weeks after surgery (baseline) and continues for 3 months. Participants are individually assign

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 07/05/2014: 1. Aged greater than or equal to 18 to less than or equal to 63 years, either sex 2. Shoulder impingement syndrome or acromioclavicular osteoarthritis (International Classification of Diseases 10th revision [ICD-10] group M75.1-M75.8, M19.8) 3. Arthroscopic surgery with a shoulder surgery code of KNBH51 or KNBH91 (or related codes depending on coding praxis at the participating surgical departments) according to the Danish version of the NOMESCO Classification of Surgical Procedures 4. Consent that the employer may be contacted as part of the study 5. Ability to complete questionnaires written in Danish 6. Ability to carry on a conversation in Danish without an interpreter Inclusion criteria were adjusted in April 2012 due to slow recruitment. Previous inclusion criteria: 1. Aged greater than or equal to 18 to less than or equal to 63 years, either sex 2. Shoulder impingement syndrome or acromioclavicular osteoarthritis (International Classification of Diseases 10th revision [ICD-10]: M75.1 - M75.8, M19.8) 3. Arthroscopic surgery with a shoulder surgery code of KNBH51 or KNBH91 (or related codes depending on coding praxis at the participating surgical departments) according to the Danish version of the NOMESCO Classification of Surgical Procedures 4. Employed with at least 25 hours of work per week 5. Fulltime sick-listed due to shoulder symptoms eight weeks after surgery with no firm date of returning to work within two weeks 6. Consent that the employer may be contacted as part of the study 7. Ability to complete questionnaires written in Danish 8. Ability to carry on a conversation in Danish without an interpreter

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 07/05/2014: 1. Fibromyalgia, rheumatoid arthritis 2. Traumatic shoulder lesion 3. Glenohumeral osteoarthritis 4. Full-thickness or complete rotator cuff tear observed during surgery Previous exclusion criteria: 1. Previous shoulder surgery (same or opposite shoulder) 2. Fibromyalgia, rheumatoid arthritis, diabetes 3. Traumatic shoulder lesion 4. Glenohumeral osteoarthritis 5. Full-thickness or complete rotator cuff tear observed during surgery

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 07/05/2014: 1. To evaluate the effectiveness of the physiotherapy intervention at 3 and 12 months: disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the occupational intervention at 3 months: number of hours of sick-leave due to symptoms from the operated shoulder in relation to the number of planned working hours within 3 months from baseline (self-report) 3. To evaluate the effectiveness of the occupational intervention at 12 months: number of weeks receiving temporary or permanent health-related transfer incomes within 12 months from baseline divided by 52 weeks, according to data from the DREAM register 4. To evaluate the effectiveness of both interventions at 24 months: for the employed subgroup, number of weeks receiving health-related transfer incomes within 13-24 months from baseline, divided by 52 weeks, according to the DREAM register Previous primary outcome measures: 1. To evaluate the effectiveness of the physiotherapy intervention at three months: disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the occupational intervention at three months: duration of fulltime sick-leave due to symptoms from the operated shoulder assessed as number of calendar days within three months from baseline (self-report) 3. To evaluate the effectiveness of both interventions at 12 months: 3.1. Duration of sick-leave until lasting RTW, i.e. number of weeks on full- or parttime sick-leave until RTW for a continuous period of at least four weeks within 12 months from baseline according to data from the DREAM register 3.2. Direct and indirect costs 4. To evaluate the effectiveness of both interventions at 24 months: number of weeks receiving health-related transfer incomes within 24 months from baseline according to the DREAM register	—

Measure

Time frame

Current primary outcome measures as of 07/05/2014: 1. To evaluate the effectiveness of the physiotherapy intervention at 3 and 12 months: disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the occupational intervention at 3 months: number of hours of sick-leave due to symptoms from the operated shoulder in relation to the number of planned working hours within 3 months from baseline (self-report) 3. To evaluate the effectiveness of the occupational intervention at 12 months: number of weeks receiving temporary or permanent health-related transfer incomes within 12 months from baseline divided by 52 weeks, according to data from the DREAM register 4. To evaluate the effectiveness of both interventions at 24 months: for the employed subgroup, number of weeks receiving health-related transfer incomes within 13-24 months from baseline, divided by 52 weeks, according to the DREAM register Previous primary outcome measures: 1. To evaluate the effectiveness of the physiotherapy intervention at three months: disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the occupational intervention at three months: duration of fulltime sick-leave due to symptoms from the operated shoulder assessed as number of calendar days within three months from baseline (self-report) 3. To evaluate the effectiveness of both interventions at 12 months: 3.1. Duration of sick-leave until lasting RTW, i.e. number of weeks on full- or parttime sick-leave until RTW for a continuous period of at least four weeks within 12 months from baseline according to data from the DREAM register 3.2. Direct and indirect costs 4. To evaluate the effectiveness of both interventions at 24 months: number of weeks receiving health-related transfer incomes within 24 months from baseline according to the DREAM register

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Secondary

Measure	Time frame
Current secondary outcome measures as of 07/05/2014: 1. To evaluate the effectiveness of the occupational intervention at 3 months: 1.1. Disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the physiotherapy intervention at 3 months: 2.1. Disability as measured by Constant Score 2.2. For the employed subgroup, number of hours of sick-leave due to symptoms from the operated shoulder in relation to the number of planned working hours within 3 months from baseline 3. To evaluate the effectiveness of both interventions at 3 months: 3.1. Fear avoidance beliefs as measured by the Fear Avoidance Belief Score (modified to focus on the shoulder) 4. To evaluate the effectiveness of the occupational intervention at 12 months: 4.1. Disability as measured by Oxford Shoulder Score 5. To evaluate the effectiveness of the physiotherapy intervention at 12 months: 5.1. For the employed subgroup, number of weeks receiving temporary or permanent health-related transfer incomes within 12 months from baseline divided by 52 weeks, according to data from the DREAM register Several supplementary outcome measures will be used including direct and indirect costs. Previous secondary outcome measures: 1. To evaluate the effectiveness of the occupational intervention at three months: 1.1. Disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of both interventions at three months: 2.1. Disability as measured by Constant Score 2.2. Work ability as measured by item 1 from the Work Ability Index 2.3. Patient Global Impression of Change since baseline 2.4. Patient satisfaction 2.5. Fear avoidance beliefs as measured by the Fear Avoidance Belief Score (modified to focus on the shoulder) 3. To evaluate the effectiveness of both interventions at 12 months: 3.1. Disability as measured by Oxford Shoulder Score 3.2. Full return to own or other work with equal earnings (yes/no, self-report) Supplementary outcome measures: 4. Pain intensity in the	—

Measure

Time frame

Current secondary outcome measures as of 07/05/2014: 1. To evaluate the effectiveness of the occupational intervention at 3 months: 1.1. Disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of the physiotherapy intervention at 3 months: 2.1. Disability as measured by Constant Score 2.2. For the employed subgroup, number of hours of sick-leave due to symptoms from the operated shoulder in relation to the number of planned working hours within 3 months from baseline 3. To evaluate the effectiveness of both interventions at 3 months: 3.1. Fear avoidance beliefs as measured by the Fear Avoidance Belief Score (modified to focus on the shoulder) 4. To evaluate the effectiveness of the occupational intervention at 12 months: 4.1. Disability as measured by Oxford Shoulder Score 5. To evaluate the effectiveness of the physiotherapy intervention at 12 months: 5.1. For the employed subgroup, number of weeks receiving temporary or permanent health-related transfer incomes within 12 months from baseline divided by 52 weeks, according to data from the DREAM register Several supplementary outcome measures will be used including direct and indirect costs. Previous secondary outcome measures: 1. To evaluate the effectiveness of the occupational intervention at three months: 1.1. Disability as measured by Oxford Shoulder Score 2. To evaluate the effectiveness of both interventions at three months: 2.1. Disability as measured by Constant Score 2.2. Work ability as measured by item 1 from the Work Ability Index 2.3. Patient Global Impression of Change since baseline 2.4. Patient satisfaction 2.5. Fear avoidance beliefs as measured by the Fear Avoidance Belief Score (modified to focus on the shoulder) 3. To evaluate the effectiveness of both interventions at 12 months: 3.1. Disability as measured by Oxford Shoulder Score 3.2. Full return to own or other work with equal earnings (yes/no, self-report) Supplementary outcome measures: 4. Pain intensity in the

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Countries

Denmark

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026