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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Applied Sciences Utrecht

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

11 Participants
are divided into 1 treatment group
Group A: Phase A: Baseline conditionsExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Patient-specific activity limitations

Patient-specific activity limitations will be measured with the Patient Specific Functional Scale (PSFS). For each patient, three personally relevant activities will be selected, each linked to a specific goal (e.g., "working 20 minutes at the computer" rather than "computer work"). For each activity, participants will answer: "How difficult was it for you to perform this activity over the past two days?". Responses range from 0 = no difficulty to 10 = impossible to perform the activity. The PSFS is a validated evaluative instrument recommended for patients with NSNP with a MIC of 2.7 points in people with NSNP.

Time frame
Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.
2

Pain coping

Pain coping will be measured using the Pain Coping Inventory (PCI). The PCI is a 33-item self-report questionnaire that assesses how patients cope with pain. Patients rate how often they use different coping strategies on a 4-point Likert scale ranging from 1 = rarely or never to 4 = very often. The questionnaire comprises six subscales: pain transformation, distraction, reducing demands, retreating, worrying, and resting. These subscales are grouped into two higher-order dimensions: active pain coping (pain transformation, distraction, reducing demands) and passive pain coping (retreating, worrying, resting). Higher scores indicate more frequent use of the corresponding coping strategies. The PCI is a valid and reliable instrument for assessing pain coping in patients with chronic pain.

Time frame
Baseline (Week 1), start of intervention phase (Week 4), and post-intervention (study completion, an average of 7 weeks)
3

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

Quality of life will be assessed using the Visual Analogue Scale of the EQ-5D (EQ-5D-VAS). Participants will answer: "How good or bad was your health over the past two days?" The vertical VAS ranges from 0 = worst imaginable health to 100 = best imaginable health. The EQ-5D-VAS demonstrates good practical usability and moderate to good reliability in Dutch populations. No MIC has been established for NSNP.

Time frame
Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.
4

Pain interference

Pain interference will be measured using the Interference scale of the Brief Pain Inventory Short Form (BPI-SF). Patients will rate the extent to which pain interfered with daily activities by answering: "To what extent has pain interfered with the following aspects of your life during the past 24 hours?" Each domain is scored from 0 = no interference to 10 = complete interference. Domains include: mood, enjoyment of life, relationships with others, sleep, general activity, walking ability, and work. Scores are calculated as the mean of at least four completed items. A Dutch translation is available. The interference scale demonstrates good psychometric properties in musculoskeletal pain conditions. No MIC is established for NSNP.

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

Other outcomes

1

Stress

Single item: I feel stressed. Scale from 0 (not at all / never applicable) to 100 (very much / mostly applicable). Higher scores indicate higher stress levels and are considered less favorable for recovery.

Time frame
Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.
2

Sleep

Singe item: I wake up in the morning feeling rested. Scale from 0 (not at all / never applicable) to 100 (very much / mostly applicable). Higher scores indicate better sleep quality and are considered more favorable for recovery.

Time frame
Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.
3

Coping

Two Single items: 1. When I have neck pain, I continue my activities, but less precise. 2. When I have neck pain, I take care that I don't have to exert myself physically. Scale from 0 (not at all / never applicable) to 100 (very much / mostly applicable). Higher scores on the first item indicate more adaptive coping (continuing activities despite pain) and are considered more favorable for recovery. Higher scores on the second item indicate avoidance of physical exertion and are considered less favorable for recovery.

Time frame
Outcomes will be assessed three times per week, from baseline (Week 1) through study completion, an average of 7 weeks.
4

Pain Catastrophizing

Single item: When I have neck pain, I worry all the time about whether the pain will end. Scale from 0 (not at all / never applicable) to 100 (very much / mostly applicable). Higher scores indicate more pain catastrophizing and are considered less favorable for recovery.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: