Stratified Physiotherapeutic (Blended) Care in Neck and Shoulder Complaints

NCT05680753 | Completed

• 2 other identifiers: NL69963.041.19NL8249
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain; Shoulder Pain

Keywords

Stratified care; Physiotherapy; Blended care

Outcome Measures

Primary Outcomes (2)

• Neck pain and disability score (NPAD; for patients with neck pain)

  The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

  9 months

• Shoulder pain and disability index (SPADI; for patients with shoulder pain)

  The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

  9 months

Secondary Outcomes (19)

• Neck and/or shoulder pain intensity

  3 months

• Neck and/or shoulder pain intensity

  9 months

• Health-related quality of life

  3 months

• Health-related quality of life

  9 months

• Illness perceptions

  3 months

Other Outcomes (3)

• The content of physiotherapy care

  Through treatment completion, an average of 3 months

• The intensity of physiotherapy care

  Through treatment completion, an average of 3 months

• Adherence to the smartphone app with e-Exercise modules in the Stratified Blended Approach arm

  Through treatment completion, an average of 3 months

Study Arms (2)

Stratified Blended Approach arm

EXPERIMENTAL

First, physiotherapists will use two stratification tools to decide the most suitable content and intensity as well as mode of care delivery of primary care physiotherapy. The content and intensity of physiotherapy will be matched to the patient's risk of persistent disabling pain as assessed with the Keele STarT MSK tool. The mode of care delivery of physiotherapy will be matched to the patient's suitability for blended care as assessed using the Dutch Blended Physiotherapy Checklist (i.e. yes or no). Second, physiotherapists will receive two practical tools to provide the matched treatment of the mode of care delivery. If considered suitable for blended care, the patient will receive a blended physiotherapy treatment (e-Exercise), in which a smartphone app with personalized information, exercises and physical activity modules is an integral part of physiotherapy treatment. If patients are considered not to be suitable for blended care, a paper-based workbook will be integrated.

Behavioral: Physiotherapy

Usual physiotherapy arm

ACTIVE COMPARATOR

Patients in the usual physiotherapy arm will be offered usual care (face-to-face or video consults) based upon the recommendations of the guidelines of the Royal Dutch Association for Physiotherapy (KNGF). The clinical guideline for neck pain, recommends categorization in treatment profiles based on: the severity of neck pain, the course of symptoms (normal vs. deviant) and the presence of psychosocial factors that may hinder recovery (yes vs. no). The clinical guideline for complaints of the arm, neck and shoulder recommends categorization in treatment profiles based on the region of complaints indicated as most problematic and the relationship between complaints, disabilities, and limitations in participation. No stratification tools to identify patient subgroups and subsequently match them to a treatment are recommended by the guidelines.

Behavioral: Physiotherapy

Interventions

Physiotherapy BEHAVIORAL

Physiotherapy

Stratified Blended Approach arm; Usual physiotherapy arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• years or older;
• sufficient mastery of the Dutch language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mark van Tilburg: lead

Study Sites (1)

HU University of applied sciences Utrecht

Utrecht, 3584CS, Netherlands

Location

MeSH Terms

Conditions

Neck Pain; Shoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Cindy Veenhof, Prof. dr.

  HU University of applied sciences Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of participating physiotherapists is not possible. However, neither physiotherapists nor patients in the usual physiotherapy care arm will be informed about the Stratified Blended Approach arm. During the analyses, the researchers will be blinded to group allocation until the entire analysis will be completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: A multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial (cRCT) will be conducted.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 11, 2023
• Study Start: January 13, 2020
• Primary Completion: October 2, 2023
• Study Completion: November 1, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will first be used by the research team for analyses. Then we will determine when data will be made available. Within the limitations of protecting personal data, we strive to make the datasets and syntaxes as openly available as possible to ensure the transparency and reproducibility of our research.

Locations

NL (1)