To assess the (cost-)effectiveness of the Stratified Physiotherapeutic (Blended) Care approach versus usual physiotherapy in primary care patients with neck and/or shoulder complaints.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Musculoskeletale klachten van de nek en de schouder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: neck and shoulder-specific pain and disability on the long
term (9 months).
Secondary outcome
Secondary outcomes are: neck and shoulder-specific pain and disability on the
short term (3 months), long-term reduction of neck and shoulder related costs,
pain intensity, quality of life, illness perceptions, self-management skills,
physical activity, exercise adherence, perceived effect, satisfaction with
treatment and number of treatment sessions.
Background summary
Patients with neck and shoulder complaints experience pain and reduced physical
functioning, resulting in high (in)direct societal costs. It is hypothesized
that treatment can be improved by stratifying healthcare by matching the right
treatment to the right patient. The two following tools can be used to stratify
primary care physiotherapy.
1) The Keele STarT MSK Tool can be used to identify groups of patients
depending on their risk of persistent disabling pain and disability (low,
medium and high risk) in order to match them to appropriate treatments.
2) The Dutch Blended Physiotherapy Checklist determines whether a patient is
suitable to receive a blended treatment and, if so, to what extent patients
need more or less physiotherapy sessions alongside a digital application. The
tool will be used to select the most appropriate mode of delivery of the
physiotherapy treatment, namely integrating an app or workbook within
physiotherapy sessions.
An example of evidence-based blended physiotherapy is e-Exercise, in which
physiotherapy sessions are integrated with a smartphone-application to support
patients self-management skills. Recently, an e-Exercise application has been
developed for patients with neck and/or shoulder complaints. For patients that
are not suitable to receive a blended treatment, an information workbook with
the same content as the smartphone-application was developed.
The two tools (Keele STarT MSK tool and the Dutch Blended Physiotherapy
Checklist) will be integrated within the physiotherapeutic treatment process to
match patients to the appropriate treatment. The prototype of this Stratified
Physiotherapeutic (Blended) Care (SPBC) approach for treating patients with
neck and/or shoulder complaints was developed in co-creation with patients,
physiotherapists and relevant stakeholders. Feasibility of the SPBC approach
was recently tested in a single group, non-randomized study. Based on patients*
and physiotherapists* experiences improvements were made. For the development,
evaluation and implementation of SPBC we use a theoretical framework, the
CeHRes Framework.
Study objective
To assess the (cost-)effectiveness of the Stratified Physiotherapeutic
(Blended) Care approach versus usual physiotherapy in primary care patients
with neck and/or shoulder complaints.
Study design
A pragmatic multicentre cluster randomized controlled trial (cRCT) will be
conducted. Physiotherapy practices will be randomized to either the usual
physiotherapy arm or the SPBC intervention.
Intervention
According to the SPBC approach, patients will be matched to an appropriate
treatment (six groups) based on their risk of persistent disabling pain
(assessed with the Keele STarT MSK Tool - either low, medium or high risk) and
their suitability for blended care (assessed with the Dutch Blended
Physiotherapy Checklist - either suitable or unsuitable for blended care).
Based on patients risk profile, the physiotherapy treatment will be targeted to
patients* individual needs. If considered suitable for blended care, the
patient will receive a blend of physiotherapy treatment sessions (e-Exercise)
and an app with personalized information, exercises and physical activity
modules that will be integrated within physiotherapy care. If patients are
considered unsuitable for blended care, they will receive an information
workbook with similar content as the app will be integrated physiotherapy
sessions. The app and the information workbook aim to support adherence to
physical activity and exercise recommendations. Content of care was based on
the Dutch KNGF Clinical Practice Guidelines for Physiotherapy Neck pain,
Complaints of Arm, Neck and Shoulder (CANS) and Subacromial complaints.
Study burden and risks
The risks for participants are expected to be negligible, because of the low
burden of the SPBC approach. The content of the intervention is based on
current literature, guidelines and focus groups. Therefore, risks for
participating patients in the intervention arm are expected to be similar to
usual physiotherapy care. The burden of the data collection consists of filling
out questionnaires at baseline, 3 and 12 months. Cost questionnaires will be
sent at 3, 6 and 9 months and used for the cost-effectiveness and cost-utility
analysis. Additionally patients are asked to wear an accelerometer on their
waist for 5 consecutive days at baseline, 3 and 9 months.
Heidelberglaan 7
Utrecht 3584CS
NL
Heidelberglaan 7
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
- consulting for physiotherapy for neck and/or shoulder complaints;
- one of the following physiotherapeutic diagnoses: subacromial complaints,
biceps tendinosis, shoulder instability or non-specific musculoskeletal
complaints of the neck and/or shoulder (not caused by acute trauma (fracture or
rupture) or by any systemic disease);
- 18 years or older;
- sufficient mastery of the Dutch language.
Exclusion criteria
- neck and/or shoulder complaints caused by specific pathology, except for
subacromial impingement, biceps tendinosis and shoulder instability (e.g.
shoulder pain with loss of active and passive range of motion (frozen
shoulder), vertebral fracture, tendon rupture, Parkinson*s disease, hernia
nucleus pulposus, cervical stenosis)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69963.041.19 |
| OMON | NL-OMON27269 |