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

University of Oslo

Status: Enrolling

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

Treatments: Other: Targeted patient information package; Other: Treatment as usual (TAU); Other: Evidence based treatment strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04806191

2019/104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Targeted patient information package

Other: Evidence based treatment strategy

Treatment as usual (TAU)

Active Comparator group

Description:

The participants enrolled in the control period will receive treatment as offered in general practice.

Treatment:

Other: Treatment as usual (TAU)