F45.41 M79.7
Conditions
Interventions
Group 1: Intervention group: patients will receive access to the HELP app for 12 weeks in addition to care as usual.
Group 2: Control group: patients will not receive access to the HELP app and will r
Sponsors
regenold GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 3. Confirmed diagnosis of F45.41, or M79.7 (for at least 3 months) 4. Stable pain medication (WHO step 1-3), if prescribed, for at least 3 months 5. Access to a device (tablet, smartphone, PC, etc.) with browser access a. For Android smartphones and tablets: Android 9 or newer b. For iPhones and iPads: iOS 17 or newer 6. Sufficient abilities required for the correct use of the intervention and the device 7. Sufficient knowledge of German 8. Signed informed consent 9. Symptomatic patients with a minimum severity of pain-related impairment = 28 (Sum of BPI pain interference subscale) at study inclusion 10. Mean value of BPI pain intensity of = 4 11. Availability of internet access for use as well as an email address for registration
Exclusion criteria
Exclusion criteria: 1. Active oncological disease with tumor-related pain 2. Inability to participate in outpatient treatment 3. Changes to pharmacological pain therapy in the past 3 months or planned adjustments during the 3-month study period, pain intervention acc. to WHO step 4 4. Use of on-demand opioid medication within the last 28 days prior to enrolment 5. Current or planned psychological pain intervention (including cognitive behavioural therapy (CBT) or group therapy) in the past 3 months or during the 3-month study period 6. Presence of a systemic musculoskeletal disease 7. Neurological deficits/paralysis or cauda equina syndrome 8. Active or planned participation in other clinical studies during the 3-month study period in which the efficacy of a similar intervention is being investigated or in which medications are used that could affect the endpoints. 9. Use in the past 6 months or planned use of another app-based program for the treatment of chronic pain. 10. Planned surgeries within the 3-month study period. 11. Current pregnancy, ongoing breastfeeding, or planned pregnancy within the 3-month study period. 12. Use of a comparable therapy program (online/offline) or planned use of a comparable intervention during the study period. 13. Another person from the same household is already participating in the study. 14. Other conditions requiring treatment that, in the opinion of the investigator, could distort the study results or represent a contraindication to participation (e.g., acute or severe cardiovascular, respiratory, or gastrointestinal diseases; current psychiatric treatment indicating severe psychiatric disorders or acute suicidality, active alcohol abuse. 15. Poly-substance use = current use of >2 classes of psychoactive substances in the last month or current SUD (substance use disorder) diagnoses for =2 classes or any other substance use within three month prior to enrolment, that, in the opinion of the investigator could impact patient safety or the integrity of study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean individual change in pain-related interference (pain interference subscale of the Brief Pain Inventory, BPI) after 12 weeks of treatment, expressed as a percentage relative to baseline, in the intervention group (HELP app) compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: Mean individual change after 12 weeks of treatment (relative to baseline) with the HELP app compared to the control group in terms of: • Pain intensity (Questions 3–6, Brief Pain Inventory, BPI) • Sleep disturbances (Insomnia Severity Index, ISI) • Anxiety symptoms (Generalized Anxiety Disorder Scale-7, GAD-7) • Depressive symptoms (Patient Health Questionnaire-9, PHQ-9) • Proportion of responders (individual clinically relevant improvement as compared to baseline in all five primary and secondary outcomes measures) Safety endpoints: • Number and frequency of adverse events • Change in concomitant medication from t0 to t1 (12 weeks) Exploratory endpoints • Analysis of all primary and secondary endpoints as changes from EoT to FuP. This is done as an exploratory “post-hoc” analysis. • Number of days with rescue medication use • Proportion of participants with rescue medication use | — |
Countries
Germany
Outcome results
None listed