Evidence based treatment strategy
OtherEvidence-based clinical examination and treatment plan
NCT Number: NCT04806191
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Department of Research and innovation, Helse Fonna, Norway, Haugesund, Vestland, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evidence-based clinical examination and treatment plan
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.).
Usual care as provided by the GP
Time frame: Change from 0 to 12 weeks
13 item patient reported questionnaire on shoulder pain and disability. (0 = no pain or shoulder disability, 100 = worst pain and disability).
Time frame: Change from 0 weeks to 52 weeks
Health related quality of life ((0 (death) - 1.0 (perfect health))
Time frame: 0 week (after 1. visit to general practitioner)
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.
Time frame: Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.
1 item (7-point) ( 0 = worse than ever, 7 =I have become completely well)
Time frame: Measured at 0, 6, 12, 52 weeks, Primary time point of interest is 12 weeks and analysing changescore from 0 to 12 weeks.
Illness perception 0-80 where a higher score reflects a more threatening view of the illness
Time frame: Measured at 0, 6, 12, 52 weeks, primary time point of interest is 12 weeks analysing change score from 0 to 12 weeks.
Self efficacy for pain 0-60 where higher score reflects higher self efficacy for pain.
Time frame: Measured at 0, 6, 12, 52 weeks
Sick leave reported as whole days away from work
Time frame: Measured at 0 weeks
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
Time frame: Measured at 0, 6, 12, 52 weeks
Reported number of consultations by GPs, specialists (orthopeds, rheumatologists, physiatrists or neurologists), physiotherapists, chiropractists and alternative therapists, injections and surgery.
Time frame: Measured at 0, 6, 12, 52 weeks
Number of investigations; blood tests and radiology (Projectional radiograph, CT, MRI)
Time frame: Measured at 0, 6, 12, 52 weeks
Patient reported use of medication reported as type of medication and frequency last week
Time frame: Measured at 0, 6, 12, 52 weeks
Patient reported travel distance to therapy measured in km
Time frame: Measured at 0, 6, 12, 52 weeks
Patient reported time away for therapy measured in hours
Time frame: Measured at 0, 6, 12, 52 weeks
Patient reported time away from work measured in hours
Time frame: Measured at 0, 6, 12, 52 weeks
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.
Time frame: Measured at 52 weeks
Registry data
Time frame: Measured at 6, 12, 52 weeks
1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied
Time frame: Measured at 0 weeks
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.
Time frame: Measured at 0 week, 12 weeks
1 item measured on a 7-point Likert scale. A higher score indicate higher patient perceived outcome expectancy.
Time frame: Measured at 52 weeks
Qualitative interview with selected patients, feasibility/ barriers and facilitators
Time frame: Measured at 2 weeks, 12 weeks
Measurement of the implementation process from the perspective of the GPs
Time frame: Measured at 0 week, 2 weeks,12 weeks
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
Time frame: Measured at 0 weeks
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.
Time frame: Measured at 12 weeks
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.
Time frame: Measured at 12 weeks
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.
Time frame: Measured at 52 weeks
Qualitative interview with selected GPs, feasibility/ barriers and facilitators
University of Oslo
Other
Making Shoulder Pain Simple in General Practice-implementing an Evidenced Based Guideline for Shoulder Pain, a Hybrid Design Cluster Randomised Study
Acronym: EASIER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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