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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Myalgia, Shoulder Pain, Frozen Shoulder, Rotator Cuff Tendinosis, Rotator Cuff Impingement Syndrome, Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Intervention / Treatment
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* Other: Evidence based treatment strategy
* Other: Targeted patient information package
* Other: Treatment as usual (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Stepped wedge randomized study
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Change from 0 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the EuroQol quality of life measure (EQ5D-5L) | Health related quality of life ((0 (death) - 1.0 (perfect health)) | 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. | 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 at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General practice, Implementation, Guideline