Preliminary Effectiveness of Process-Based Personalized Physiotherapy for (Sub)Acute Neck Pain

NCT07704593 | Not Yet Recruiting

• 2 other identifiers: 354-003-2026RAAK.MKB21.010
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical trial is to learn if personalized physiotherapy can lower neck pain in adults with recent (sub)acute neck pain who have a higher chance of the pain becoming long-lasting. The main questions it aims to answer are: Does personalized physiotherapy lower pain compared to standard physiotherapy? Does personalized physiotherapy improve daily activities, quality of life, and pain interference compared to standard physiotherapy? Do physiotherapists deliver the personalized treatment as intended? Researchers will compare each participant's own results during a standard care period to their results during a personalized care period, to see if the personalized approach works better than standard care. Participants will: Receive standard physiotherapy care for 3 weeks Then receive personalized physiotherapy, tailored to their individual needs, for several weeks (until their treatment goals are achieved) Answer short questions about their pain and daily functioning three times a week Take part in an interview about their experiences every 3 weeks

Conditions

Precision Medicine

Keywords

Neck Pain; Physical Therapy; Single-Case Studies as Topic

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be measured using an 11-point Numeric Pain Rating Scale (NPRS). Patients will answer the question: "How intense was your pain on average over the past two days?" Responses range from 0 = no pain to 10 = worst imaginable pain. The NPRS is a validated instrument recommended in the Royal Dutch Society for Physical Therapy (KNGF) Neck Pain Guideline for evaluating pain intensity. The Minimal Important Change (MIC) for patients with neck pain is 2.5 points.

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

Secondary Outcomes (9)

• Patient-specific activity limitations

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

• Pain coping

  Baseline (Week 1), start of intervention phase (Week 4), and post-intervention (study completion, an average of 7 weeks)

• Quality of Life as Measured by EQ-5D-VAS

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

• Pain interference

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

• Perceived effect

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

Other Outcomes (9)

• Stress

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

• Sleep

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

• Coping

  Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.

Study Arms (1)

Phase A: Baseline conditions

EXPERIMENTAL

During the three-week baseline phase (A), participants will receive standard care, consisting of an intake and two treatment sessions in accordance with the KNGF Clinical Practice Guideline for Neck Pain. Diagnostic procedures will include anamnesis (screening for red flags, classification of neck pain, assessment of symptom characteristics and interference with daily functioning based on the International Classification of Functioning (ICF), as well as symptom course and onset), optionally supplemented with physical examination. Standard care interventions will be delivered according to treatment profile and may include education and advice, mobilizations, and exercise therapy. During the baseline phase, the physiotherapist will deliver usual care without access to the Clinical Compass results and therefore without structured insight into the participant's potentially modifiable biopsychosocial processes targeted in the intervention phase.

Behavioral: Personalized physiotherapy grounded in the PBT framework

Interventions

Personalized physiotherapy grounded in the PBT framework BEHAVIORAL

During the intervention phase (B-phase), treatment follows the steps of personalized physiotherapy grounded in a PBT framework. Treatment is continuously adapted to the identified and prioritized modifiable biopsychosocial process, as jointly mapped and evaluated with the patient throughout the treatment trajectory. Intervention sequencing is not time-driven but process-driven, with session-by-session evaluation guiding when to continue, adapt, or shift intervention targets. The identification and ongoing evaluation of relevant processes is informed by the Clinical Compass and, where indicated, supplemented with one or more items from the supplementary item pool. Assessment is guided by a structured biopsychosocial evaluation using the SCEGS framework (Somatic, Cognitive, Emotional, Behavioral, Social), which supports systematic exploration of somatic symptoms, cognitions, emotions, behaviors, and social context to identify modifiable processes.

Phase A: Baseline conditions

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• New episode of neck pain with duration ≤12 weeks since onset
• Neck pain located in the region shown in Figure 2
• ≥19% risk of developing chronic complaints, as determined using a prognostic model
• If a previous episode of neck pain occurred, the current episode must have been preceded by ≥3 consecutive months without persistent pain (defined as absence of pain associated with activity limitation or healthcare consultation)

You may not qualify if:

• Prior neck surgery
• Cervical radiculopathy as identified using the Upper Limb Neurodynamic Test (ULNT1)
• Widespread primary pain according to ICD-11 criteria (diffuse musculoskeletal pain in ≥4 of 5 body regions, across ≥3 body quadrants, involving the axial skeleton)
• Pain of non-musculoskeletal origin
• Insufficient proficiency in Dutch to read or understand study instructions

Sponsors & Collaborators

• University of Applied Sciences Utrecht: lead
• Maastricht University: collaborator

Study Sites (9)

Medifit Oss

Oss, North Brabant, 5345 SC, Netherlands

Location

Fysio- Manuele Therapie Lutke Schipholt c.s.

Tilburg, North Brabant, 5046 DA, Netherlands

Location

Lijfkracht Fysiotherapie

Drachten, Provincie Friesland, 9202 PD, Netherlands

Location

Expertisecentrum Fysiotherapie

Groningen, Provincie Groningen, 9713 CA, Netherlands

Location

Douglas Fysiotherapie & Sport

Alphen aan den Rijn, South Holland, 2401 PR, Netherlands

Location

FS Fysio

Capelle aan den IJssel, South Holland, 2909 VA, Netherlands

Location

Fysio-Experts

Hazerswoude-Rijndijk, South Holland, 2394 AG, Netherlands

Location

Fysiotherapeutisch centrum Palenstein

Zoetermeer, South Holland, 2722 RX, Netherlands

Location

Praktijk Boshuijzen Manuele therapie

Amersfoort, Utrecht, 3817 VB, Netherlands

Location

Related Links

• Project Information

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sophie Konings, MSc

  University of Applied Sciences Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Konings, MSc

CONTACT

0031638907717; sophie.konings@hu.nl

Martine Verwoerd, Dr.

CONTACT

0031884812820; martine.verwoerd@hu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Only the raters evaluating the audio recordings for intervention fidelity are blinded to the phase
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will employ a replicated MMSCR with a convergent, parallel, mixed methods approach, in which quantitative and qualitative data will be collected concurrently and subsequently integrated. The quantitative component follows a nonconcurrent AB SCED structure with repeated measurement. Each participant undergoes a baseline phase (A) with standard care, followed by an intervention phase (B) of personalized physiotherapy grounded in a PBT framework. The phase sequence is predetermined: the baseline phase spans three weeks with a minimum of nine measurement points, and the intervention phase lasts at least 2 weeks with a minimum of six measurement points. The number of measurements per phase is based on the required discriminative power to detect changes in the trajectory of outcome variables. Intervention phase duration is patient-dependent; given the target population and average treatment episode length for NSNP, a longer phase is expected.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: De-identified quantitative data, statistical code, and the study protocol will become available following publication of the primary study results, expected in 2028. Data will remain available for at least 5 years after publication via DataverseNL, in accordance with FAIR data principles.
• Access Criteria: Data will be shared via DataverseNL following review by a data steward to ensure compliance with GDPR and participant privacy protections. De-identified quantitative data and analytic code will be accessible to researchers upon reasonable request for legitimate secondary research purposes. Qualitative data (interview transcripts, audio recordings) will not be shared publicly due to re-identification risk. Access may be restricted where necessary to protect participant confidentiality.

Locations

NL (9)