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

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

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.

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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

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806191


Contacts
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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
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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
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Principal Investigator: Niels G Juel, MD, PhD Department of General practice, University of Oslo
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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