BACKGROUND
Globally, musculoskeletal diseases are the leading cause of chronic pain, physical impairments, and loss of quality of life. Transcutaneous electrical nerve stimulation (TENS) is used to modulate pain sensation. tiNa-start is a digital treatment support for patients with musculoskeletal pain diagnoses who receive a TENS device to self-administer at home. tiNa-start provides educational content, a therapy phase concept, recommendations and reminders, self-monitoring, mental training and more.
OBJECTIVE
The study was designed to test the hypothesis that the digital support provided by tiNa-start for a TENS therapy results in an increase of treatment adherence accompanied by improved patient functionality leading to a positive health care effect in patients with musculoskeletal pain.
METHODS
The study was a two-arm multi-center, parallel group, randomised, controlled trial with an open-label study design. This interim analysis included a total of 87 patients (37% men, 63% women) aged 45.7 ± 14.3 years undergoing interventional treatment with tiNa-start (N=45) versus a control group (N=42) receiving usual care of treatment. The primary objective of the study was to evaluate the number of adherent treatment days following tiNa-start compared to the control group. Secondary aims included treatment effects on patient reported outcome questionnaires related to the patient´s primary area of disability.
RESULTS
The primary study endpoint patient’s adherence significantly (P=.04) improved following tiNa-start compared with the control group. Changes in patient reported outcome scores were correlated with the degree of patient adherence for all disease related specific instruments, KOOS-ADL, and ODI and NDI. A trend for a clinically relevant improvement on patient functionality between the intervention groups could be observed for KOOS-ADL. All adverse events were observed in the control group and were related to pain in patients with knee injury and neck pain. The Net Promotor Score of the application was +32%.
CONCLUSIONS
Treatment intervention with the tiNA-start showed increased adherence to the prescribed TENS therapy schedule accompanied with improvements of patient functionality scores and a reduction of adverse events. More severely impacted pain patients and higher adherence scores provided better patient clinical outcomes.
CLINICALTRIAL
German registry for clinical trials (DRKS00030387).