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

NCT ID: NCT04806191

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2023-12-30

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Stepped wedge randomized study
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Evidence based treatment strategy

Intervention Type OTHER

Evidence-based clinical examination and treatment plan

Targeted patient information package

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type OTHER

Usual care as provided by the GP

Interventions

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Evidence based treatment strategy

Evidence-based clinical examination and treatment plan

Intervention Type OTHER

Targeted 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.).

Intervention Type OTHER

Treatment as usual (TAU)

Usual care as provided by the GP

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Fonna

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Niels Gunnar JUEL

MD. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels G Juel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of General practice, University of Oslo

Locations

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Department of Research and innovation, Helse Fonna, Norway

Haugesund, Vestland, Norway

Site Status RECRUITING

Department of General Practice, University of Oslo

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Stein J Pedersen, MD

Role: CONTACT

90162213 ext. +47

Ole M Ekeberg, MD, PhD

Role: CONTACT

91745757 ext. +47

Facility Contacts

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Ole M Ekeberg, MD, PhD

Role: primary

91745757 ext. +47

Eva Biringer, MD, PhD

Role: backup

97156593 ext. +47

Stein J Pedersen, MD

Role: primary

90162213 ext. +47

Niels G Juel, MD, PhD

Role: backup

92443113 ext. +47

References

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Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

Reference Type BACKGROUND
PMID: 22310560 (View on PubMed)

Artus M, van der Windt DA, Afolabi EK, Buchbinder R, Chesterton LS, Hall A, Roddy E, Foster NE. Management of shoulder pain by UK general practitioners (GPs): a national survey. BMJ Open. 2017 Jun 21;7(6):e015711. doi: 10.1136/bmjopen-2016-015711.

Reference Type BACKGROUND
PMID: 28637737 (View on PubMed)

Ekeberg OM, Pedersen SJ, Natvig B, Brox JI, Biringer EK, Endresen Reme S, Engebretsen KB, Joranger P, Mdala I, Juel NG. Making shoulder pain simple in general practice: implementing an evidence-based guideline for shoulder pain, protocol for a hybrid design stepped-wedge cluster randomised study (EASIER study). BMJ Open. 2022 Jan 7;12(1):e051656. doi: 10.1136/bmjopen-2021-051656.

Reference Type DERIVED
PMID: 34996788 (View on PubMed)

Other Identifiers

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2019/104

Identifier Type: -

Identifier Source: org_study_id

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