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

Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stein J Pedersen, MD; Phone Number: +47 90162213; Email: s.j.pedersen@medisin.uio.no
• Study Contact Backup: Name: Ole M Ekeberg, MD, PhD; Phone Number: +47 91745757; Email: omae@helse-fonna.no

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • Department of General Practice, University of Oslo
    • Contact: Stein J Pedersen, MD; Phone Number: +47 90162213; Email: s.j.pedersen@medisin.uio.no
    • Contact: Niels G Juel, MD, PhD; Phone Number: +47 92443113; Email: UXNGJU@ous-hf.no
  • Vestland
    • Haugesund, Vestland, Norway, 5504
      • Recruiting
      • Department of Research and innovation, Helse Fonna, Norway
      • Contact: Ole M Ekeberg, MD, PhD; Phone Number: +47 91745757; Email: omae@helse-fonna.no
      • Contact: Eva Biringer, MD, PhD; Phone Number: +47 97156593; Email: eva.kristin.hope.aaker.biringer@helse-fonna.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Evidence based treatment strategy; Evidence-based clinical examination and treatment plan; 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.).
Active Comparator: Treatment as usual (TAU); The participants enrolled in the control period will receive treatment as offered in general practice.	Other: Treatment as usual (TAU); Usual care as provided by the GP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the EuroQol quality of life measure (EQ5D-5L)	Health related quality of life ((0 (death) - 1.0 (perfect health))	Change from 0 weeks to 52 weeks
Patient reported quality of care index (treatment according to the guideline intervention)	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.	0 week (after 1. visit to general practitioner)
Global patient perceived effect of treatment outcome (GPE)	1 item (7-point) ( 0 = worse than ever, 7 =I have become completely well)	Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief illness perception questionnaire (BIPQ)	Illness perception 0-80 where a higher score reflects a more threatening view of the illness	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)	Self efficacy for pain 0-60 where higher score reflects higher self efficacy for pain.	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	Sick leave reported as whole days away from work	Measured at 0, 6, 12, 52 weeks
Örebro Musculoskeletal Pain Screening Questionnaire (Short)	Psychosocial, prognostic factors for musculoskeletal pain. The total score will range between 1 and 100, with a score >50 indicating higher estimated risk for future work disability	Measured at 0 weeks
Pateint reported frequency of therapy due to shoulder pain in primary and secondary health care	Reported number of consultations by GPs, specialists (orthopeds, rheumatologists, physiatrists or neurologists), physiotherapists, chiropractists and alternative therapists, injections and surgery.	Measured at 0, 6, 12, 52 weeks
Patient reported frequency of use of supplemental investigations in primary and secondary health care.	Number of investigations; blood tests and radiology (Projectional radiograph, CT, MRI)	Measured at 0, 6, 12, 52 weeks
Patient reported direct economical expences due to shoulder pain	Patient reported use of medication reported as type of medication and frequency last week	Measured at 0, 6, 12, 52 weeks
Patient reported indirect economical expences due to shoulder pain; travel distance to therapy	Patient reported travel distance to therapy measured in km	Measured at 0, 6, 12, 52 weeks
Patient reported indirect economical expences due to shoulder pain; time away for therapy measured in hours	Patient reported time away for therapy measured in hours	Measured at 0, 6, 12, 52 weeks
Patient reported indirect economical expences due to shoulder pain; time away for work measured in hours.	Patient reported time away from work measured in hours	Measured at 0, 6, 12, 52 weeks
Patient reported indirect economical expences due to shoulder pain; production loss.	Patient reported production loss measured as patient estimated per cent production loss due to shoulder pain. A higher number means a higher loss of production.	Measured at 0, 6, 12, 52 weeks
Work disability from the Norwegian Labour and Welfare Administration registry	Registry data	Measured at 52 weeks
Global patient perceived satisfaction with treatment	1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied	Measured at 6, 12, 52 weeks
Patient experience questionnaire (PEQ)	4 subscales (communication, emotions, outcome, barriers) with 4 items measured on 4 or 7 point Likert scales. A high score represents a good communication experience, positive emotions, positive consultation outcome, no communication barriers.	Measured at 0 weeks
Patient Shoulder Outcome Expectancies	1 item measured on a 7-point Likert scale. A higher score indicate higher patient perceived outcome expectancy.	Measured at 0 week, 12 weeks
Patient interview (qualitative)	Qualitative interview with selected patients, feasibility/ barriers and facilitators	Measured at 52 weeks
Implementation process assesment tool (IPAT)	Measurement of the implementation process from the perspective of the GPs	Measured at 2 weeks, 12 weeks
GPs self-efficacy for handling patients with shoulder pain according to guideline care	9 items measured on 6-point Likert scales analysing change in individual items and sum score before and 12 weeks after educational outreach. A higher score indicates higher self-efficacy	Measured at 0 week, 2 weeks,12 weeks
GPs global perceived satisfaction with workshop (GP)	10 item measured on 5-point Likert scales concerning satisfaction with the different topics and content of the work shop.We will analyze individual items. A higher score indicate higher satisfaction.	Measured at 0 weeks
GPs global perceived satisfaction, benefit, usability and frequency of use of the intervention (GP)	4 item measured on 5-point Likert scales. We will analyze individual items. A higher score indicate higher satisfaction, benefit, usability and frequency of use of the intervention.	Measured at 12 weeks
GPs use of the intervention in daily practice; degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement (GP)	4 items measured on 7-point Likert scales. We will analyze individual items. A higher score indicate higher degree of use in daily practice and a higher degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement.	Measured at 12 weeks
GP focus groups	Qualitative interview with selected GPs, feasibility/ barriers and facilitators	Measured at 52 weeks

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Helse Fonna
• Investigators: Principal Investigator: Niels G Juel, MD, PhD, Department of General Practice, University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Implementation; General practice; Guideline
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Shoulder Injuries; Tendon Injuries; Arthralgia; Myalgia; Rotator Cuff Injuries; Tendinopathy; Rupture; Shoulder Impingement Syndrome; Shoulder Pain; Bursitis
• Other Study ID Numbers: 2019/104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No