Lower back (M51.0, M51.1, M51.2, M51.3, M51.8, M51.9, M53.86, M53.87, M53.96, M53.97, M54.16, M54.17, M54.3, M54.4, M54.86, M54.87, M54.96, M54.97, M54.5) Neck (M53.0, M53.1, M53.82, M53.92, M54.12, M54.2, M54.82, M54.92) M51.0 M53.0 M17.1 M17.5 M17.9
Conditions
Interventions
Group 1: Intervention group with prescribed TENS therapy and additionally the digital application TENS-1
Group 2: Control group with prescribed TENS therapy
Sponsors
NEXTEC medical GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Prescription of TENS treatment for one positional electrode application only, for between 2 and 3 treatment sessions per day lasting between 15 and 30 minutes per treatment session. 2. Patient is able to independently apply electrodes and perform self-treatment with TENS. 3. Confirmed diagnoses in one of the following areas with pain lasting longer than two weeks - Lower back (M51.0, M51.1, M51.2, M51.3, M51.8, M51.9, M53.86, M53.87, M53.96, M53.97, M54.16, M54.17, M54.3, M54.4, M54.86, M54.87, M54.96, M54.97, M54.5) - Nape (M53.0, M53.1, M53.82, M53.92, M54.12, M54.2, M54.82, M54.92) - Knee (M17.1, M17.5, M17.9) - Shoulder (M25.51, M75.1, M75.4, M75.8, M75.9) 4. No change in pain medication in the last four weeks prior to start of study 5. Age: at least 18 years old 6. Smartphone (Android or iOS) and Internet access 7. Email address to register 8. Informed consent 9. Ability to understand German (spoken and written) 10. Sex: male or female
Exclusion criteria
Exclusion criteria: 1. Contraindications such as pacemaker 2. Prior treatment with TENS in the last three months 3. Planned use at start or for the duration of study of comparable digital support applications, comparable treatments (e.g., electrotherapies), planned hospital stays (e.g., for pain treatment) or planned surgeries if they encompass systemic application of anaesthetics or inability of patient to apply electrodes at any time 4. Pregnancy or breastfeeding 5. Other reasons which may pose a risk to patient health or quality of data in the physician´s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence: in comparison with the control group, number of treatment adherent days, defined as days during which the patient has at least met the number and duration of prescribed sessions divided by the number of all possible adherent treatment days in the timeframe of intervention Adherence is measured by evaluating the TENS devices at the end of study Timeline: FPI Q1 2023 - LPO: Q1 2024 Duration of participation: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functionality Change of score from questionnaire on disability related quality of life at end of study compared to begin of study 2. Patient autonomy Change of score of patient activation measure (PAM13-D) at end of study compared to begin of study 3. Pain Change of score of Brief Pain Inventory (BPI – Pain Severity) questionnaire at end of study compared to begin of study 4. Responder analysis Proportion of adherent days: the number of adherent days divided by the number of all possible adherent days over the duration of the intervention - Proportion of patients who were adherent on at least 50% of treatment days (low adherence) - Proportion of patients who were adherent on between 50 and 80% of treatment days (moderate adherence) - Proportion of patients who were adherent on at least 80% of treatment days (high adherence) | — |
Countries
Germany
Contacts
Public ContactSven Gottttschling
Zentrum für altersübergreifende Palliativmedizin und KinderschmerztherapieUniversitätsklinikum des Saarlandes (UKS), Gebäude 69, 1. OG, Zimmer 1.04
Outcome results
None listed