A pilot study on app-based treatment, combining physical exercise, graded activity, and pain journaling for patients with spinal complaints.

A pilot study on app-based treatment, combining physical exercise, graded activity, and pain journaling for patients with spinal complaints. - SPINAPP Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57321

Enrollment

Registered

2025-02-20

Start date

2025-04-30

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

back pain chronic back pain Spinal complaints

Interventions

5.1 Investigational product/treatment The app-based treatment consists of a combination of physical therapy, graded activity, and pain journaling. The app will be installed on the participant's mobi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: o Patients visiting the spine-centre at Zuyderland Medical Centre. o Suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment would be advised. o Minimum age of 18 years. o Psychosocially, mentally, and physically able to fully comply with this study protocol. o Informed consent prior to this study.

Exclusion criteria

Exclusion criteria: o Requiring a specific intervention (e.g., surgery, pain treatment, rehabilitation, bracing) o Inadequate command of the Dutch language. o Digitally illiterate or otherwise unable to use an application on a mobile phone. o Active spinal infection. o Immature bone (ongoing growth). o Active malignancy. o Pregnancy.

Design outcomes

Primary

Measure	Time frame
8.1.1 Main study parameter/endpoint The primary outcome is change in QoL measured from baseline to three-month follow-up using the EQ-5D-5L. With interval measurements at baseline and after one, two and three months of treatment.	—

Secondary

Measure	Time frame
o Demographics o Change in pain, measured with the Visual Analogue Scale (VAS). o Change in disability, measured with the Oswestry Disability Index (ODI). o Change in lost productivity, measured with missed working days. o Change in Body Mass Index, measured using patients* input on length and weight. o Adherence of participants measured using frequency of patients* input in the mobile application. o Patients* experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews. o Safety measured using the (serious) adverse events ((S)AE). Adverse events: increased pain or discomfort for which the patient visits the hospital, neurological deficits, technology-related issues. Adverse events will be followed up to 30 days after completion of the treatment period.	—

Measure

Time frame

o Demographics o Change in pain, measured with the Visual Analogue Scale (VAS). o Change in disability, measured with the Oswestry Disability Index (ODI). o Change in lost productivity, measured with missed working days. o Change in Body Mass Index, measured using patients* input on length and weight. o Adherence of participants measured using frequency of patients* input in the mobile application. o Patients* experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews. o Safety measured using the (serious) adverse events ((S)AE). Adverse events: increased pain or discomfort for which the patient visits the hospital, neurological deficits, technology-related issues. Adverse events will be followed up to 30 days after completion of the treatment period.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026