Clinical trial NCT05680753: Stratified Physiotherapeutic (Blended) Care in Neck and Shoulder Complaints
Official title: A Stratified Approach Integrated With eHealth in Primary Care Physiotherapy for Patients With Neck and/or Shoulder Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Shoulder Pain
Keywords: Stratified care
Physiotherapy
Blended care
Lead sponsor: University of Applied Sciences Utrecht
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial (cRCT) will be conducted.
Primary purpose: TREATMENT

Brief summary: The aim of this cluster RCT is to investigate the clinical effectiveness of a Stratified Blended Approach for patients with neck and/or shoulder complaints on pain and disability over 9 months, compared to usual physiotherapy care.

Our secondary aims are twofold:

* to investigate the effectiveness of the Stratified Blended Approach for patients with neck and/or shoulder complaints on pain intensity, health-related quality of life, illness perceptions, self-management skills, physical activity, exercise adherence, self-perceived effect and satisfaction at 3 and 9 months, compared to usual physiotherapy care;
* to investigate the cost-effectiveness and cost-utility of the Stratified Blended Approach for patients with neck and/or shoulder complaints, compared to usual physiotherapy care.

In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual.

This study is financially supported by the Scientific College Physiotherapy (WCF), part of the Royal Dutch Association for Physiotherapy (KNGF). WCF has no role in study design, data collection and analysis, decision to publish, or preparation of the manuscripts. External peer-review took place during the funding process. The results will be publicly disclosed unreservedly.

Detailed description: Intervention:

According to the Stratified Blended approach, patients will be matched to an appropriate treatment 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 digital and face-to-face blend of physiotherapy treatment (e-Exercise) in which an app with personalized information, exercises and physical activity modules is integrated with face-to-face 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 with face-to-face physiotherapy. The app and the information workbook aims 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.

Control group:

Usual physiotherapy. 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.

Eligibility criteria: Inclusion criteria: Patients with neck and/or shoulder complaints will be recruited within participating physiotherapy practices. In order to be eligible to participate in the data collection for the trial, a patient must meet all of the following 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: A patient who meets any of the following criteria will not be suitable to take part in the data collection for the trial:

* neck and/or shoulder complaints caused by specific pathology (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), except for subacromial impingement, biceps tendinosis and shoulder instability.

Primary outcomes:
measure: Neck pain and disability score (NPAD; for patients with neck pain)
timeFrame: 9 months
measure: Shoulder pain and disability index (SPADI; for patients with shoulder pain)
timeFrame: 9 months
Secondary outcomes:
measure: Neck and/or shoulder pain intensity
timeFrame: 3 months
measure: Neck and/or shoulder pain intensity
timeFrame: 9 months
measure: Health-related quality of life
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 9 months
measure: Illness perceptions
timeFrame: 3 months
measure: Illness perceptions
timeFrame: 9 months
measure: Patients' self-management skills
timeFrame: 3 months
measure: Patients' self-management skills
timeFrame: 9 months
measure: Physical activity
timeFrame: 3 months
measure: Physical activity
timeFrame: 9 months
measure: Exercise adherence
timeFrame: 3 months
measure: Exercise adherence
timeFrame: 9 months
measure: Global perceived effect
timeFrame: 3 months
measure: Global perceived effect
timeFrame: 9 months
measure: Satisfaction with treatment
timeFrame: 3 months
measure: Neck pain and disability score (NPAD; for patients with neck pain)
timeFrame: 3 months
measure: Shoulder pain and disability index (SPADI; for patients with shoulder pain)
timeFrame: 3 months
measure: Cost-effectiveness (assessed with a cost questionnaire)
timeFrame: 9 months
measure: Cost-utility (assessed with a cost questionnaire)
timeFrame: 9 months
Other outcomes:
measure: The content of physiotherapy care
timeFrame: Through treatment completion, an average of 3 months
measure: The intensity of physiotherapy care
timeFrame: Through treatment completion, an average of 3 months
measure: Adherence to the smartphone app with e-Exercise modules in the Stratified Blended Approach arm
timeFrame: Through treatment completion, an average of 3 months
Locations:
city: Utrecht
country: Netherlands
facility: HU University of applied sciences Utrecht
Study officials:
affiliation: HU University of applied sciences Utrecht
name: Cindy Veenhof, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: