Increase of adherence, autonomy, and disease-related functionality in patients with musculoskeletal pain using a supportive digital application (tiNa-start) with their home-based TENS treatment

Not Applicable

• Conditions: ower 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; Lumbar and other intervertebral disc disorders with myelopathy; Cervicocranial syndrome; Other primary gonarthrosis; Other secondary gonarthrosis

• Registration Number: DRKS00030387
• Lead Sponsor: EXTEC medical GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-24
• Study Completion: 2023-10-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 258

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Adherence is measured by evaluating the TENS devices at the end of study<br><br>Timeline: FPI Q1 2023 - LPO: Q1 2024<br>Duration of participation: 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Functionality<br>Change of score from questionnaire on disability related quality of life at end of study compared to begin of study<br>2. Patient autonomy<br>Change of score of patient activation measure (PAM13-D) at end of study compared to begin of study<br>3. Pain<br>Change of score of Brief Pain Inventory (BPI – Pain Severity) questionnaire at end of study compared to begin of study<br>4. Responder analysis<br>Proportion of adherent days: the number of adherent days divided by the number of all possible adherent days over the duration of the intervention<br>- Proportion of patients who were adherent on at least 50% of treatment days (low adherence)<br>- Proportion of patients who were adherent on between 50 and 80% of treatment days (moderate adherence)<br>- Proportion of patients who were adherent on at least 80% of treatment days (high adherence)