Shoulder PainEASIERNCT04806191
Simple and Evidence-based Examination and Treatment of Shoulder Pain in General Practice
A study testing Evidence based treatment strategy, Targeted patient information package and Treatment as usual (TAU) in people with Shoulder Pain and Frozen Shoulder, run by University of Oslo at 2 sites in Norway.
Trial summary
Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Frozen Shoulder, Rotator Cuff Tendinosis
- What is being tested?
- Evidence based treatment strategy, Targeted patient information package and Treatment as usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesNorway
- Study dates
- 11 Mar 2021to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain in the shoulder region
- Above 18 years
Who cannot join
- Unable to fill in self-report questionnaires or do not understand Norwegian
- Acute injury with clinical suspicion of fracture, luxation of shoulder joints or large tendon ruptures
- Clinical suspicion of referred pain to the shoulder area from other organs
- Signs of inflammatory joint disease
- Suspicion of malignant disease
- Symptoms and signs of cervical radiculopathy
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Research and innovation, Helse Fonna, Norway
Haugesund, Vestland, 5504
Department of General Practice, University of Oslo
Oslo, 0450
About this study
Official title: Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study
Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder pain in general practice.
Read the detailed description
A simplified and evidence-based algorithm for examination and treatment of patients with shoulder pain will be developed and implemented in general practice. The purpose is to improve quality of care and provide GPs with a simplified and efficient tool to handle patients with common shoulder- related pain. The study is a stepped-wedge, cluster-randomized trial with a hybrid design including a effectiveness, cost and implementation assessment of a guideline-based intervention in clinical practice (2). General practitioners in Norway will be recruited and the GP offices will be randomized to the time of crossover from current treatment as usual (TAU) to the implementation of the intervention. The intervention is a tailored strategy that includes workshops for general practitioners covering information and access to a decision support tool, an education program where the general practitioner learn an evidence-based approach to shoulder pain and access to patient information materials. Outcomes will be measured at patient and GP levels, using self-report questionnaires, focus group interviews and register based data.
- Conditions
- Shoulder Pain, Frozen Shoulder, Rotator Cuff Tendinosis, Myalgia, Rotator Cuff Impingement Syndrome, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Being tested
- Evidence based treatment strategy, Targeted patient information package, Treatment as usual (TAU)
- Keywords
- General practice, Implementation, Guideline
- Medical subject headings
- Shoulder Pain, Bursitis, Rotator Cuff Injuries, Myalgia, Shoulder Impingement Syndrome, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based treatment strategyOther
Evidence-based clinical examination and treatment plan
Targeted patient information packageOther
GPs will in cooperation with the patients tailor a information package targeted to the patients needs regarding their clinical shoulder diagnosis and individual implications and needs (Pain, sleep, exercises etc.).
Usual care as provided by the GP
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management. Receives: Other: Evidence based treatment strategy; Other: Targeted patient information package |
| Treatment as usual (TAU) | Active comparator | The participants enrolled in the control period will receive treatment as offered in general practice. Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI)
13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability).
Measured: Change from 0 to 12 weeks
Secondary outcomes (3)
the EuroQol quality of life measure (EQ5D-5L)
Health related quality of life ((0 (death) - 1.0 (perfect health))
Measured: Change from 0 weeks to 52 weeks
Patient reported quality of care index (treatment according to the guideline intervention)
Patient reported content of treatment measured on six items according to treatment prescribed by the GP measured on 5-item Likert scales. Sum score above 18 points regarded as consultation of high quality according to guideline intervention.
Measured: 0 week (after 1. visit to general practitioner)
Global patient perceived effect of treatment outcome (GPE)
1 item (7-point) ( 0 = worse than ever, 7 =I have become completely well)
Measured: Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start11 Mar 2021
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Fonna
- Responsible party
- Principal investigator, Niels Gunnar JUEL, University of Oslo
- Investigators
- Niels G Juel, MD, PhD, Principal investigator, Department of General practice, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806191
- Sponsor's protocol ID
- 2019/104
- Acronym
- EASIER
- Status last verified
- May 2026
- First submitted
- 3 Mar 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Artus M, van der Windt DA, Afolabi EK, Buchbinder R, Chesterton LS, Hall A, Roddy E, Foster NE. Management of shoulder pain by UK general practitioners (GPs): a national survey. BMJ Open. 2017 Jun 21;7(6):e015711. doi: 10.1136/bmjopen-2016-015711.
PubMed 28637737Ekeberg OM, Pedersen SJ, Natvig B, Brox JI, Biringer EK, Endresen Reme S, Engebretsen KB, Joranger P, Mdala I, Juel NG. Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study). BMJ Open. 2022 Jan 7;12(1):e051656. doi: 10.1136/bmjopen-2021-051656.
PubMed 34996788
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study
- ClinicalTrials.gov ID
- NCT04806191
- Acronym / sponsor ID
- EASIER / 2019/104
- Conditions
- Shoulder Pain, Frozen Shoulder, Rotator Cuff Tendinosis, Myalgia, Rotator Cuff Impingement Syndrome, Rotator Cuff Tear or Rupture, Not Specified as Traumatic
- Keywords
- General practice, Implementation, Guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Helse Fonna
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Mar 2021 (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.
Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder pain in general practice.
Detailed description
A simplified and evidence-based algorithm for examination and treatment of patients with shoulder pain will be developed and implemented in general practice. The purpose is to improve quality of care and provide GPs with a simplified and efficient tool to handle patients with common shoulder- related pain. The study is a stepped-wedge, cluster-randomized trial with a hybrid design including a effectiveness, cost and implementation assessment of a guideline-based intervention in clinical practice (2). General practitioners in Norway will be recruited and the GP offices will be randomized to the time of crossover from current treatment as usual (TAU) to the implementation of the intervention. The intervention is a tailored strategy that includes workshops for general practitioners covering information and access to a decision support tool, an education program where the general practitioner learn an evidence-based approach to shoulder pain and access to patient information materials. Outcomes will be measured at patient and GP levels, using self-report questionnaires, focus group interviews and register based data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped wedge randomized study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Evidence based treatment strategy, Other: Targeted patient information packagePatients will be assessed by GPs who have attended an outreach workshop and trained at using an evidence based strategy for shoulder examination and treatment. GPs will have access to a decision support tool and patients is offered a tailored information package for self management. |
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usual (TAU)The participants enrolled in the control period will receive treatment as offered in general practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain in the shoulder region
- Above 18 years
Key exclusion criteria (6 listed)
- Unable to fill in self-report questionnaires or do not understand Norwegian
- Acute injury with clinical suspicion of fracture, luxation of shoulder joints or large tendon ruptures
- Clinical suspicion of referred pain to the shoulder area from other organs
- Signs of inflammatory joint disease
- Suspicion of malignant disease
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 |
|---|---|---|
| Evidence based treatment strategyEvidence-based clinical examination and treatment plan | Other | Intervention |
| Targeted patient information packageGPs will in cooperation with the patients tailor a information package targeted to the patients needs regarding their clinical shoulder diagnosis and individual implications and needs (Pain, sleep, exercises etc.). | Other | Intervention |
| Treatment as usual (TAU)Usual care as provided by the GP | Other | Treatment as usual (TAU) |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI)
Time frame: Change from 0 to 12 weeks
13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability).
3 secondary outcomes
the EuroQol quality of life measure (EQ5D-5L)
Time frame: Change from 0 weeks to 52 weeks
Patient reported quality of care index (treatment according to the guideline intervention)
Time frame: 0 week (after 1. visit to general practitioner)
Global patient perceived effect of treatment outcome (GPE)
Time frame: Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.
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 2 Jun 2026.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 28637737Artus M, van der Windt DA, Afolabi EK, Buchbinder R, Chesterton LS, Hall A, Roddy E, Foster NE. Management of shoulder pain by UK general practitioners (GPs): a national survey. BMJ Open. 2017 Jun 21;7(6):e015711. doi: 10.1136/bmjopen-2016-015711.
- Derived from this study: PubMed 34996788Ekeberg OM, Pedersen SJ, Natvig B, Brox JI, Biringer EK, Endresen Reme S, Engebretsen KB, Joranger P, Mdala I, Juel NG. Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study). BMJ Open. 2022 Jan 7;12(1):e051656. doi: 10.1136/bmjopen-2021-051656.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Niels G Juel, MD, PhD principal investigator
Department of General practice, University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence based treatment strategy, Targeted patient information package and Treatment as usual (TAU) in people with Shoulder Pain and Frozen Shoulder, run by University of Oslo at 2 sites in Norway.
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 2 inclusion and 6 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 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Change in Shoulder Pain and Disability Index (SPADI) (time frame: Change from 0 to 12 weeks). 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 NCT04806191, which also lists 3 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 2 Jun 2026.