Frozen Shoulder, Myalgia, Rotator Cuff Impingement Syndrome, Rotator Cuff Tear or Rupture, Not Specified as Traumatic, Rotator Cuff Tendinosis, Shoulder Pain
Conditions
Keywords
General practice, Implementation, Guideline
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.
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.
Interventions
OTHEREvidence based treatment strategy
Evidence-based clinical examination and treatment plan
OTHERTargeted 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.).
OTHERTreatment as usual (TAU)
Usual care as provided by the GP
Sponsors
University of Oslo
Helse Fonna
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
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.
Intervention model description
Stepped wedge randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shoulder Pain and Disability Index (SPADI) | 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
| Measure | Time frame | Description |
|---|---|---|
| the EuroQol quality of life measure (EQ5D-5L) | Change from 0 weeks to 52 weeks | Health related quality of life ((0 (death) - 1.0 (perfect health)) |
| Patient reported quality of care index (treatment according to the guideline intervention) | 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. |
| Global patient perceived effect of treatment outcome (GPE) | 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) |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORNiels G Juel, MD, PhD
Department of General practice, University of Oslo
Outcome results
None listed