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Completed

NCT Number: NCT04806191

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evidence based treatment strategy

Other

Evidence-based clinical examination and treatment plan

Targeted patient information package

Other

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.).

Treatment as usual (TAU)

Other

Usual care as provided by the GP

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Helse Fonna

Registry information

Official study title

Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study

Acronym: EASIER

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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