An interventional study of Evidence based treatment strategy and Targeted patient information package in Shoulder Pain, Frozen Shoulder and Rotator Cuff Tendinosis, sponsored by University of Oslo. Completed at 2 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Oslo · Not applicable, Interventional, and Health services research
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.
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.
735 studies on the registry are indexed under Shoulder Pain; 167 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 587 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Oslo is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
The participants enrolled in the control period will receive treatment as offered in general practice.
Other: Treatment as usual (TAU)
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
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).
Time frame: Change from 0 to 12 weeks
the EuroQol quality of life measure (EQ5D-5L)
Health related quality of life ((0 (death) - 1.0 (perfect health))
Time frame: 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.
Time frame: 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)
Time frame: Measured at 6,12 and 52 weeks. Primary analysis of interest is at 12 weeks.
Brief illness perception questionnaire (BIPQ)
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 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.
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.
Work disability patient reported
Sick leave reported as whole days away from work
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Measured at 0, 6, 12, 52 weeks
Work disability from the Norwegian Labour and Welfare Administration registry
Registry data
Time frame: Measured at 52 weeks
Global patient perceived satisfaction with treatment
1 item (5-point Likert scale); 0=dissatisfied, 5=very satisfied
Time frame: 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.
Time frame: 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.
Time frame: Measured at 0 week, 12 weeks
Patient interview (qualitative)
Qualitative interview with selected patients, feasibility/ barriers and facilitators
Time frame: Measured at 52 weeks
Implementation process assesment tool (IPAT)
Measurement of the implementation process from the perspective of the GPs
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 12 weeks
GP focus groups
Qualitative interview with selected GPs, feasibility/ barriers and facilitators
Time frame: Measured at 52 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Dec 2024, 45 months.
Of 349 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 45 months is above that.
Counting every sponsor, half of 354 studies reached it within 11 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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