Clinical trial NCT04806191: Simple and Evidence-based Examination and Treatment of Shoulder Pain in General Practice
Official title: Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Helse Fonna
First posted: 2021-03-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge randomized study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from 0 to 12 weeks
Secondary outcomes:
measure: the EuroQol quality of life measure (EQ5D-5L)
timeFrame: Change from 0 weeks to 52 weeks
measure: Patient reported quality of care index (treatment according to the guideline intervention)
timeFrame: 0 week (after 1. visit to general practitioner)
measure: Global patient perceived effect of treatment outcome (GPE)
timeFrame: Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.
Other outcomes:
measure: Brief illness perception questionnaire (BIPQ)
timeFrame: Measured at 0, 6, 12, 52 weeks, Primary time point of interest is 12 weeks and analysing changescore from 0 to 12 weeks.
measure: Pain self-efficacy questionnaire (PSEQ)
timeFrame: Measured at 0, 6, 12, 52 weeks, primary time point of interest is 12 weeks analysing change score from 0 to 12 weeks.
measure: Work disability patient reported
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Örebro Musculoskeletal Pain Screening Questionnaire (Short)
timeFrame: Measured at 0 weeks
measure: Pateint reported frequency of therapy due to shoulder pain in primary and secondary health care
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported frequency of use of supplemental investigations in primary and secondary health care.
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported direct economical expences due to shoulder pain
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported indirect economical expences due to shoulder pain; travel distance to therapy
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported indirect economical expences due to shoulder pain; time away for therapy measured in hours
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported indirect economical expences due to shoulder pain; time away for work measured in hours.
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Patient reported indirect economical expences due to shoulder pain; production loss.
timeFrame: Measured at 0, 6, 12, 52 weeks
measure: Work disability from the Norwegian Labour and Welfare Administration registry
timeFrame: Measured at 52 weeks
measure: Global patient perceived satisfaction with treatment
timeFrame: Measured at 6, 12, 52 weeks
measure: Patient experience questionnaire (PEQ)
timeFrame: Measured at 0 weeks
measure: Patient Shoulder Outcome Expectancies
timeFrame: Measured at 0 week, 12 weeks
measure: Patient interview (qualitative)
timeFrame: Measured at 52 weeks
measure: Implementation process assesment tool (IPAT)
timeFrame: Measured at 2 weeks, 12 weeks
measure: GPs self-efficacy for handling patients with shoulder pain according to guideline care
timeFrame: Measured at 0 week, 2 weeks,12 weeks
measure: GPs global perceived satisfaction with workshop (GP)
timeFrame: Measured at 0 weeks
measure: GPs global perceived satisfaction, benefit, usability and frequency of use of the intervention (GP)
timeFrame: Measured at 12 weeks
measure: GPs use of the intervention in daily practice; degree of simplifying shoulder evaluation and treatment, recommending exercises, information and patient involvement (GP)
timeFrame: Measured at 12 weeks
measure: GP focus groups
timeFrame: Measured at 52 weeks
Locations:
city: Haugesund
country: Norway
facility: Department of Research and innovation, Helse Fonna, Norway
state: Vestland
city: Oslo
country: Norway
facility: Department of General Practice, University of Oslo
Study officials:
affiliation: Department of General practice, University of Oslo
name: Niels G Juel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.