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

Shoulder Pain Clinical Trial

— EASIER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806191
• Other study ID #: 2019/104
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: University of Oslo
• Contact: Stein J Pedersen, MD
• Phone: 90162213
• Email: s.j.pedersen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Evidence based treatment strategy
Evidence-based clinical examination and treatment plan
• 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.).
• Treatment as usual (TAU)
Usual care as provided by the GP

Locations

Country	Name	City	State
Norway	Department of Research and innovation, Helse Fonna, Norway	Haugesund	Vestland
Norway	Department of General Practice, University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	Helse Fonna

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Work disability patient reported	Sick leave reported as whole days away from work	Measured at 0, 6, 12, 52 weeks
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Work disability from the Norwegian Labour and Welfare Administration registry	Registry data	Measured at 52 weeks
Other	Global patient perceived satisfaction with treatment	1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied	Measured at 6, 12, 52 weeks
Other	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
Other	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
Other	Patient interview (qualitative)	Qualitative interview with selected patients, feasibility/ barriers and facilitators	Measured at 52 weeks
Other	Implementation process assesment tool (IPAT)	Measurement of the implementation process from the perspective of the GPs	Measured at 2 weeks, 12 weeks
Other	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
Other	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
Other	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
Other	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
Other	GP focus groups	Qualitative interview with selected GPs, feasibility/ barriers and facilitators	Measured at 52 weeks
Primary	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	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
Secondary	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)
Secondary	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.