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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic; Shoulder Pain; Myalgia; Rotator Cuff Impingement Syndrome; Frozen Shoulder; Rotator Cuff Tendinosis
• Interventions: Other: Treatment as usual (TAU); Other: Evidence based treatment strategy; Other: Targeted patient information package

• Registration Number: NCT04806191
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2021-03-03
• Study Start: 2021-03-11
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03
• Primary Completion: 2023-05-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment as usual (TAU)	Treatment as usual (TAU)	The participants enrolled in the control period will receive treatment as offered in general practice.
Intervention	Evidence based treatment strategy	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.
Intervention	Targeted patient information package	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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))

Trial Locations

Locations (2)

Department of Research and innovation, Helse Fonna, Norway; 🇳🇴 Haugesund, Vestland, Norway

Department of General Practice, University of Oslo; 🇳🇴 Oslo, Norway