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Research project

SIX

Status: Ongoing (November 2019 - July 2023)

The SIX (Shoulder Injection and eXercise) study is a clinical study for the treatment of persistent shoulder pain in primary care.

What we do

About our project

Background
The guideline for shoulder pain issued by the Dutch College of General Practitioners (NHG) recommends a local corticosteroid injection or referral to physiotherapist-led exercise therapy if shoulder pain persists after initial advice and analgesia. However, the guideline acknowledges the lack of evidence to favor one option over the other. The recently released NHG research agenda listed research on the effectiveness of corticosteroid injections for patients with shoulder pain as a top priority. This study will evaluate the clinical and cost-effectiveness of these two treatments and aims to strengthen future decision making in the treatment of persistent shoulder pain.

Hypothesis
We hypothesize that the clinical and cost-effectiveness of physiotherapist-led exercise is greater than corticosteroid injections after 12 months.

Methods
A total of 213 patients, aged 18 years and older, who contacted their general practitioner with a new episode of shoulder pain and who did not respond to advice and analgesia will be included. Patients will be randomly allocated to either a local corticosteroid injection or physiotherapist-led exercise therapy. The effects of treatment will evaluated by questionnaires at 6 weeks, 3, 6, 9, and 12 months after initial treatment.

Our research focus

Primary outcome
The primary outcome is patients’ reported pain and function of the shoulder measured with the Shoulder Pain and Disability Index (SPADI), and costs after 12 months.

Secondary outcome
Secondary outcome measures will include short and long term assessment of pain and function measured with SPADI, global perceived effect, measured with a 7-point Likert scale, health related quality of life, measured with the EQ-5D-5L, side effects, sleep quality using the Jenkins-Sleep questionnaire, work absence and healthcare utilization.

Funds & Grants

ZonMW Doelmatigheidsonderzoek (80-85200-98-20047).

Collaborations

Erasmus School of Health Policy & Management, Erasmus University
Department of Public Health and Primary Care, Maastricht University
Primary Care Musculoskeletal Research Centre, Keele University

Our team

Dr. J. Runhaar (co-promotor), j.runhaar@erasmusmc.nl
Dr. E.I.T. de Schepper (co-promotor), e.deschepper@erasmusmc.nl
Dr. D. Schiphof, d.schiphof@erasmusmc.nl
Dr. R.P.G. Ottenheijm, ramon.ottenheijm@maastrichtuniversity.nl
Prof.dr. P.J.E. Bindels, p.bindels@erasmusmc.nl
Dr. M. Koopmanschap, koopmanschap@eshpm.eur.nl
Dr. M. Thoomes-de Graaf, marloesthoomes@me.com
Prof. dr. D. Van der Windt, d.van.der.windt@keele.ac.uk
Dr. J.M. van Ochten, j.vanochten@erasmusmc.nl
Prof.dr. B.W. Koes (promotor), b.koes@erasmusmc.nl

Contact address for the project: p.vandoorn@erasmusmc.nl.