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

NCT04806191 | Unknown

• 1 other identifier: 2019/104
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

General practice; Implementation; Guideline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the EuroQol quality of life measure (EQ5D-5L)

  Change from 0 weeks to 52 weeks

• Patient reported quality of care index (treatment according to the guideline intervention)

  0 week (after 1. visit to general practitioner)

• Global patient perceived effect of treatment outcome (GPE)

  Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.

Other Outcomes (22)

• Brief illness perception questionnaire (BIPQ)

  Measured at 0, 6, 12, 52 weeks, Primary time point of interest is 12 weeks and analysing changescore from 0 to 12 weeks.

• Pain self-efficacy questionnaire (PSEQ)

  Measured at 0, 6, 12, 52 weeks, primary time point of interest is 12 weeks analysing change score from 0 to 12 weeks.

• Work disability patient reported

  Measured at 0, 6, 12, 52 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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; Other: Targeted patient information package

Treatment as usual (TAU)

ACTIVE COMPARATOR

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

Other: Treatment as usual (TAU)

Interventions

Evidence based treatment strategy OTHER

Evidence-based clinical examination and treatment plan

Intervention

Targeted patient information package 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.).

Intervention

Treatment as usual (TAU) OTHER

Usual care as provided by the GP

Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain in the shoulder region
• Above 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead
• Helse Fonna: collaborator

Study Sites (2)

Department of Research and innovation, Helse Fonna, Norway

Haugesund, Vestland, 5504, Norway

RECRUITING

Department of General Practice, University of Oslo

Oslo, 0450, Norway

RECRUITING

Related Publications (3)

• 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.

  PMID: 22310560 BACKGROUND

• 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.

  PMID: 28637737 BACKGROUND

• 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.

  PMID: 34996788 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Bursitis; Rotator Cuff Injuries; Myalgia; Shoulder Impingement Syndrome; Rupture

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Study Officials

• Niels G Juel, MD, PhD

  Department of General practice, University of Oslo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stein J Pedersen, MD

CONTACT

90162213; s.j.pedersen@medisin.uio.no

Ole M Ekeberg, MD, PhD

CONTACT

91745757; omae@helse-fonna.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Model Details: Stepped wedge randomized study

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 19, 2021
• Study Start: March 11, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)