Simple and Evidence-based Examination and Treatment of Shoulder Pain in General Practice (EASIER)

• ClinicalTrials.gov Identifier: NCT04806191
• Recruitment Status: Recruiting
• First Posted: March 19, 2021
• Last Update Posted: May 12, 2021
• Sponsor: University of Oslo
• Collaborator: Helse Fonna
• Information provided by (Responsible Party): Niels Gunnar JUEL, University of Oslo

Study Description

Brief 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 pain in general practice.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain; Frozen Shoulder; Rotator Cuff Tendinosis; Myalgia; Rotator Cuff Impingement Syndrome; Rotator Cuff Tear or Rupture, Not Specified as Traumatic	Other: Evidence based treatment strategy; Other: Targeted patient information package; Other: Treatment as usual (TAU)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Stepped wedge randomized study
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessor will be blinded for treatment allocation. Randomization will be done after recruitment of GPs. GPs and study coordinators and outcome evaluators will be blinded to the allocation sequence with only the allocation of the next GP surgery being revealed by randomization list holder approximately 6 weeks before each intervention implementation point.
• Primary Purpose: Health Services Research
• Official Title: Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study
• Actual Study Start Date: March 11, 2021
• Estimated Primary Completion Date: April 30, 2023
• Estimated Study Completion Date: April 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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.	Other: Evidence based treatment strategy; Evidence-based clinical examination and treatment plan; Other: Targeted patient information package; 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.).
Active Comparator: Treatment as usual (TAU); The participants enrolled in the control period will receive treatment as offered in general practice.	Other: Treatment as usual (TAU); Usual care as provided by the GP

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. the EuroQol quality of life measure (EQ5D-5L) [ Time Frame: Change from 0 weeks to 52 weeks ]
   Health related quality of life ((0 (death) - 1.0 (perfect health))
2. Patient reported quality of care index (treatment according to the guideline intervention) [ Time Frame: 0 week (after 1. visit to general practitioner) ]
   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.
3. 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. ]
   1 item (7-point) ( 0 = worse than ever, 7 =I have become completely well)

Other Outcome Measures:

1. Brief illness perception questionnaire (BIPQ) [ Time Frame: Measured at 0, 6, 12, 52 weeks, Primary time point of interest is 12 weeks and analysing changescore from 0 to 12 weeks. ]
   Illness perception 0-80 where a higher score reflects a more threatening view of the illness
2. Pain self-efficacy questionnaire (PSEQ) [ Time Frame: Measured at 0, 6, 12, 52 weeks, primary time point of interest is 12 weeks analysing change score from 0 to 12 weeks. ]
   Self efficacy for pain 0-60 where higher score reflects higher self efficacy for pain.
3. Work disability patient reported [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Sick leave reported as whole days away from work
4. Örebro Musculoskeletal Pain Screening Questionnaire (Short) [ Time Frame: Measured at 0 weeks ]
   Psychosocial, prognostic factors for musculoskeletal pain. The total score will range between 1 and 100, with a score >50 indicating higher estimated risk for future work disability
5. Pateint reported frequency of therapy due to shoulder pain in primary and secondary health care [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Reported number of consultations by GPs, specialists (orthopeds, rheumatologists, physiatrists or neurologists), physiotherapists, chiropractists and alternative therapists, injections and surgery.
6. Patient reported frequency of use of supplemental investigations in primary and secondary health care. [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Number of investigations; blood tests and radiology (Projectional radiograph, CT, MRI)
7. Patient reported direct economical expences due to shoulder pain [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Patient reported use of medication reported as type of medication and frequency last week
8. Patient reported indirect economical expences due to shoulder pain; travel distance to therapy [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Patient reported travel distance to therapy measured in km
9. Patient reported indirect economical expences due to shoulder pain; time away for therapy measured in hours [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
   Patient reported time away for therapy measured in hours
10. Patient reported indirect economical expences due to shoulder pain; time away for work measured in hours. [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
    Patient reported time away from work measured in hours
11. Patient reported indirect economical expences due to shoulder pain; production loss. [ Time Frame: Measured at 0, 6, 12, 52 weeks ]
    Patient reported production loss measured as patient estimated per cent production loss due to shoulder pain. A higher number means a higher loss of production.
12. Work disability from the Norwegian Labour and Welfare Administration registry [ Time Frame: Measured at 52 weeks ]
    Registry data
13. Global patient perceived satisfaction with treatment [ Time Frame: Measured at 6, 12, 52 weeks ]
    1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied
14. Patient experience questionnaire (PEQ) [ Time Frame: Measured at 0 weeks ]
    4 subscales (communication, emotions, outcome, barriers) with 4 items measured on 4 or 7 point Likert scales. A high score represents a good communication experience, positive emotions, positive consultation outcome, no communication barriers.
15. Patient Shoulder Outcome Expectancies [ Time Frame: Measured at 0 week, 12 weeks ]
    1 item measured on a 7-point Likert scale. A higher score indicate higher patient perceived outcome expectancy.
16. Patient interview (qualitative) [ Time Frame: Measured at 52 weeks ]
    Qualitative interview with selected patients, feasibility/ barriers and facilitators
17. Implementation process assesment tool (IPAT) [ Time Frame: Measured at 2 weeks, 12 weeks ]
    Measurement of the implementation process from the perspective of the GPs
18. GPs self-efficacy for handling patients with shoulder pain according to guideline care [ Time Frame: Measured at 0 week, 2 weeks,12 weeks ]
    9 items measured on 6-point Likert scales analysing change in individual items and sum score before and 12 weeks after educational outreach. A higher score indicates higher self-efficacy
19. GPs global perceived satisfaction with workshop (GP) [ Time Frame: Measured at 0 weeks ]
    10 item measured on 5-point Likert scales concerning satisfaction with the different topics and content of the work shop.We will analyze individual items. A higher score indicate higher satisfaction.
20. GPs global perceived satisfaction, benefit, usability and frequency of use of the intervention (GP) [ Time Frame: Measured at 12 weeks ]
    4 item measured on 5-point Likert scales. We will analyze individual items. A higher score indicate higher satisfaction, benefit, usability and frequency of use of the intervention.
21. GPs use of the intervention in daily practice; degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement (GP) [ Time Frame: Measured at 12 weeks ]
    4 items measured on 7-point Likert scales. We will analyze individual items. A higher score indicate higher degree of use in daily practice and a higher degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement.
22. GP focus groups [ Time Frame: Measured at 52 weeks ]
    Qualitative interview with selected GPs, feasibility/ barriers and facilitators

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Pain in the shoulder region
• Above 18 years

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Stein J Pedersen, MD; 90162213 ext +47; s.j.pedersen@medisin.uio.no

Contact: Ole M Ekeberg, MD, PhD; 91745757 ext +47; omae@helse-fonna.no

Locations

Norway

Department of Research and innovation, Helse Fonna, Norway; Recruiting

Haugesund, Vestland, Norway, 5504

Contact: Ole M Ekeberg, MD, PhD 91745757 ext +47 omae@helse-fonna.no

Contact: Eva Biringer, MD, PhD 97156593 ext +47 eva.kristin.hope.aaker.biringer@helse-fonna.no

Department of General Practice, University of Oslo; Recruiting

Oslo, Norway, 0450

Contact: Stein J Pedersen, MD 90162213 ext +47 s.j.pedersen@medisin.uio.no

Contact: Niels G Juel, MD, PhD 92443113 ext +47 UXNGJU@ous-hf.no

Sponsors and Collaborators

University of Oslo

Helse Fonna

Investigators

• Principal Investigator: Niels G Juel, MD, PhD; Department of General practice, University of Oslo

More Information

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.

Artus 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ekeberg 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.

• Responsible Party: Niels Gunnar JUEL, MD. PhD, University of Oslo
• ClinicalTrials.gov Identifier: NCT04806191
• Other Study ID Numbers: 2019/104
• First Posted: March 19, 2021
• Last Update Posted: May 12, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Niels Gunnar JUEL, University of Oslo:

General practice; Implementation; Guideline

Additional relevant MeSH terms:

Shoulder Pain; Bursitis; Myalgia; Tendinopathy; Shoulder Impingement Syndrome; Rupture; Rotator Cuff Injuries; Wounds and Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain