Shoulder PainNCT03159910
Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures
A study testing Shoulder-Café and Shoulder-Guidance in people with Shoulder Pain, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Shoulder-Café and Shoulder-Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Aug 2017to 1 Jul 2020
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
- Shoulder complaints
- Able to read and understand Danish
Who cannot join
- Previous shoulder surgery
- Breast cancer operation
- Pregnancy
- Sickness absence expected to continue into the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures: a Cluster-randomised Controlled Study (The Shoulder-Café Study)
Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints.
Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.
Read the detailed description
Introduction:
Shoulder complaints prevail in the working age population and constitute a common cause of contacts with general practitioners. In occupations with high mechanical shoulder exposures, these complaints are especially frequent. Persons with high occupational mechanical shoulder exposures and shoulder complaints seem an obvious target group for secondary prevention efforts, and more research on interventions targeting shoulder complaints in occupations with high shoulder exposures is needed.
The aim is to develop and evaluate a Shoulder-Café intervention to reduce high occupational mechanical shoulder exposures and prolonged shoulder complaints.
The specific objectives are:
- To evaluate the effectiveness of the Shoulder-Café as compared to the control-intervention, the Shoulder-Guidance, measured on reductions in shoulder complaints.
II. To evaluate the effectiveness of the Shoulder-Café as compared to the Shoulder-Guidance measured on reductions in occupational mechanical shoulder exposures.
III. To identify the influence of shoulder exercises and reduced occupational mechanical shoulder exposures, respectively, on shoulder complaints.
The hypothesis is that the Shoulder-Café will reduce shoulder exposures and shoulder complaints more effectively than the Shoulder-Guidance. Furthermore, a hypothesis is that fear avoidance beliefs is reduced and the degree to which the participants feel informed about the nature of their complaints and their remedies is increased more effectively with the Shoulder-Café compared to the control intervention.
Method:
The project consists of a two-armed, cluster-randomised controlled trial with randomisation at company level (objectives I and II) and a prospective cohort study based on the cluster-randomised study (objective III).
Follow-up: A questionnaire 3 and 9 months after end of intervention with e.g. OSS.
- Conditions
- Shoulder Pain
- Being tested
- Shoulder-Café, Shoulder-Guidance
- Keywords
- Shoulder Pain, Occupational Exposure, Clinical Trial
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder-CaféBehavioural
Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.
Shoulder-GuidanceBehavioural
Home-based shoulder exercise and written counselling.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder-Café (intervention) | Experimental | A Shoulder-Café intervention consists of three café-meetings. Receives: Behavioral: Shoulder-Café |
| Shoulder-Guidance (control) | Active comparator | The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts. Receives: Behavioral: Shoulder-Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder complaints
Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Measured: Follow-up 3 months after end of intervention.
Mechanical shoulder exposures
Measured during 1-5 working days in terms of % time with the arm elevated at different angles and shoulder angular velocity (°/s) using an Axivity accelerometer. Degree of exertion for the arms monitored with Borg CR10 (questionnaire). Participants will fill out questions in Borg CR 10 when they are using the Axivity accelerometer.
Measured: Follow-up at end of intervention, an average of 2-3 months
Secondary outcomes (3)
Fear Avoidance Beliefs (FABQ) about physical activity (PA)
Monitored with FABQ-PA in a version modified to the shoulder (questionnaire)
Measured: Follow-up 3 and 9 months after end of intervention.
Patients' Global Impression of Change
Measured on a 7 point Likert scale.
Measured: Follow-up 3 months after end of intervention.
Shoulder complaints
Monitored with the Danish version of the Oxford Shoulder Score
Measured: Follow-up 9 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start14 Aug 2017
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Hospital West Jutland, Aarhus University Hospital, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Jeanette Trøstrup, MsC, Principal investigator, Elective Surgery Centre, Silkeborg Regional Hospital, Regional Hospital Central Jutland.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159910
- Sponsor's protocol ID
- JutlandRH
- Status last verified
- Sep 2019
- First submitted
- 11 May 2017
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
PubMed 22047932Schmidt S, Ferrer M, Gonzalez M, Gonzalez N, Valderas JM, Alonso J, Escobar A, Vrotsou K; EMPRO Group. Evaluation of shoulder-specific patient-reported outcome measures: a systematic and standardized comparison of available evidence. J Shoulder Elbow Surg. 2014 Mar;23(3):434-44. doi: 10.1016/j.jse.2013.09.029. Epub 2014 Jan 7.
PubMed 24406123Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
PubMed 8455963Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.
PubMed 20599053Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.
PubMed 2345867Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
PubMed 14739871Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.
PubMed 22325050Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
PubMed 16282408van Rijn RM, Huisstede BM, Koes BW, Burdorf A. Associations between work-related factors and specific disorders of the shoulder--a systematic review of the literature. Scand J Work Environ Health. 2010 May;36(3):189-201. doi: 10.5271/sjweh.2895. Epub 2010 Jan 22.
PubMed 20094690Anton D, Mizner RL, Hess JA. The effect of lift teams on kinematics and muscle activity of the upper extremity and trunk in bricklayers. J Orthop Sports Phys Ther. 2013 Apr;43(4):232-41. doi: 10.2519/jospt.2013.4249. Epub 2013 Jan 14.
PubMed 23321695Rempel D, Star D, Barr A, Blanco MM, Janowitz I. Field evaluation of a modified intervention for overhead drilling. J Occup Environ Hyg. 2010 Apr;7(4):194-202. doi: 10.1080/15459620903558491.
PubMed 20094939Trostrup J, Frost P, Dalboge A, Mikkelsen LR, Hoybye MT, Jorgensen LB, Casper SD, Klebe TM, Svendsen SW. Reducing Shoulder Complaints in Employees with High Occupational Shoulder Exposures: A Cluster-Randomised Controlled Study (The Shoulder-Cafe Study). J Occup Rehabil. 2023 Sep;33(3):473-485. doi: 10.1007/s10926-022-10086-z. Epub 2022 Dec 13.
PubMed 36512271Trostrup J, Svendsen SW, Dalboge A, Mikkelsen LR, Hoybye MT, Jorgensen LB, Klebe TM, Frost P. Increased shoulder pain across an exercise session and subsequent shoulder exercise: a prospective cohort study. BMC Musculoskelet Disord. 2022 Jul 29;23(1):726. doi: 10.1186/s12891-022-05674-2.
PubMed 35906579Trostrup J, Mikkelsen LR, Frost P, Dalboge A, Hoybye MT, Casper SD, Jorgensen LB, Klebe TM, Svendsen SW. Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Cafe Study). Trials. 2019 Nov 12;20(1):627. doi: 10.1186/s13063-019-3703-y.
PubMed 31718683
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures: a Cluster-randomised Controlled Study (The Shoulder-Café Study)
- ClinicalTrials.gov ID
- NCT03159910
- Acronym / sponsor ID
- JutlandRH
- Conditions
- Shoulder Pain
- Keywords
- Shoulder Pain, Occupational Exposure, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- Regional Hospital West Jutland, Aarhus University Hospital, University of Aarhus
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 19 May 2017 (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.
Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints.
Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.
Detailed description
Introduction:
Shoulder complaints prevail in the working age population and constitute a common cause of contacts with general practitioners. In occupations with high mechanical shoulder exposures, these complaints are especially frequent. Persons with high occupational mechanical shoulder exposures and shoulder complaints seem an obvious target group for secondary prevention efforts, and more research on interventions targeting shoulder complaints in occupations with high shoulder exposures is needed.
The aim is to develop and evaluate a Shoulder-Café intervention to reduce high occupational mechanical shoulder exposures and prolonged shoulder complaints.
The specific objectives are:
- To evaluate the effectiveness of the Shoulder-Café as compared to the control-intervention, the Shoulder-Guidance, measured on reductions in shoulder complaints.
II. To evaluate the effectiveness of the Shoulder-Café as compared to the Shoulder-Guidance measured on reductions in occupational mechanical shoulder exposures.
III. To identify the influence of shoulder exercises and reduced occupational mechanical shoulder exposures, respectively, on shoulder complaints.
The hypothesis is that the Shoulder-Café will reduce shoulder exposures and shoulder complaints more effectively than the Shoulder-Guidance. Furthermore, a hypothesis is that fear avoidance beliefs is reduced and the degree to which the participants feel informed about the nature of their complaints and their remedies is increased more effectively with the Shoulder-Café compared to the control intervention.
Method:
The project consists of a two-armed, cluster-randomised controlled trial with randomisation at company level (objectives I and II) and a prospective cohort study based on the cluster-randomised study (objective III).
Follow-up: A questionnaire 3 and 9 months after end of intervention with e.g. OSS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoulder-Café (intervention) | Experimental | Behavioral: Shoulder-CaféA Shoulder-Café intervention consists of three café-meetings. |
| Shoulder-Guidance (control) | Active comparator | Behavioral: Shoulder-GuidanceThe Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults
- Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
- Shoulder complaints
- Able to read and understand Danish
Key exclusion criteria (4 listed)
- Previous shoulder surgery
- Breast cancer operation
- Pregnancy
- Sickness absence expected to continue into the intervention period
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 |
|---|---|---|
| Shoulder-CaféEducation and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit. | Behavioural | Shoulder-Café (intervention) |
| Shoulder-GuidanceHome-based shoulder exercise and written counselling. | Behavioural | Shoulder-Guidance (control) |
Primary outcome
Shoulder complaints
Time frame: Follow-up 3 months after end of intervention.
Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Mechanical shoulder exposures
Time frame: Follow-up at end of intervention, an average of 2-3 months
Measured during 1-5 working days in terms of % time with the arm elevated at different angles and shoulder angular velocity (°/s) using an Axivity accelerometer. Degree of exertion for the arms monitored with Borg CR10 (questionnaire). Participants will fill out questions in Borg CR 10 when they are using the Axivity accelerometer.
3 secondary outcomes
Fear Avoidance Beliefs (FABQ) about physical activity (PA)
Time frame: Follow-up 3 and 9 months after end of intervention.
Patients' Global Impression of Change
Time frame: Follow-up 3 months after end of intervention.
Shoulder complaints
Time frame: Follow-up 9 months after end of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 22047932Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
- Background: PubMed 24406123Schmidt S, Ferrer M, Gonzalez M, Gonzalez N, Valderas JM, Alonso J, Escobar A, Vrotsou K; EMPRO Group. Evaluation of shoulder-specific patient-reported outcome measures: a systematic and standardized comparison of available evidence. J Shoulder Elbow Surg. 2014 Mar;23(3):434-44. doi: 10.1016/j.jse.2013.09.029. Epub 2014 Jan 7.
- Background: PubMed 8455963Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Background: PubMed 20599053Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.
- Background: PubMed 2345867Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. doi: 10.5271/sjweh.1815.
- Background: PubMed 14739871Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. doi: 10.1016/j.jmpt.2003.11.003.
- Background: PubMed 22325050Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17.
- Background: PubMed 16282408Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.
- Background: PubMed 20094690van Rijn RM, Huisstede BM, Koes BW, Burdorf A. Associations between work-related factors and specific disorders of the shoulder--a systematic review of the literature. Scand J Work Environ Health. 2010 May;36(3):189-201. doi: 10.5271/sjweh.2895. Epub 2010 Jan 22.
- Background: PubMed 23321695Anton D, Mizner RL, Hess JA. The effect of lift teams on kinematics and muscle activity of the upper extremity and trunk in bricklayers. J Orthop Sports Phys Ther. 2013 Apr;43(4):232-41. doi: 10.2519/jospt.2013.4249. Epub 2013 Jan 14.
- Background: PubMed 20094939Rempel D, Star D, Barr A, Blanco MM, Janowitz I. Field evaluation of a modified intervention for overhead drilling. J Occup Environ Hyg. 2010 Apr;7(4):194-202. doi: 10.1080/15459620903558491.
- Derived from this study: PubMed 36512271Trostrup J, Frost P, Dalboge A, Mikkelsen LR, Hoybye MT, Jorgensen LB, Casper SD, Klebe TM, Svendsen SW. Reducing Shoulder Complaints in Employees with High Occupational Shoulder Exposures: A Cluster-Randomised Controlled Study (The Shoulder-Cafe Study). J Occup Rehabil. 2023 Sep;33(3):473-485. doi: 10.1007/s10926-022-10086-z. Epub 2022 Dec 13.
- Individual participant dataSharing planned: No
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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.
Jeanette Trøstrup, MsC principal investigator
Elective Surgery Centre, Silkeborg Regional Hospital, Regional Hospital Central Jutland.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder-Café and Shoulder-Guidance in people with Shoulder Pain, run by Central Jutland Regional Hospital 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 Aug 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Shoulder complaints (time frame: Follow-up 3 months after end of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159910, which also lists 14 linked publications.
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 7 Aug 2020.