Clinical trial NCT06420596: The Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)
Official title: A Randomised Controlled Trial on the Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Physiotherapy
Remote app-assisted physiotherapy
Akina Cloud
Musculoskeletal assessment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this single-center, observational randomised controlled trial is to evaluate the effectiveness of using Akina Cloud, a remote app-assisted physiotherapy, in managing non-specific low back pain among patients.

Detailed description: In Switzerland, 1.5 million people suffer from low back pain (LBP), which is often the cause of disability. Non-specific LBP is a major cause of high healthcare costs in developed countries and often leads to early retirement.

The development of musculoskeletal assessment through remote app-assisted therapeutic home training may be useful for individuals with non-specific LBP, providing initial support for its implementation in primary care in the patient's home. App-supported therapeutic solutions allow healthcare professionals to prescribe and monitor rehabilitation programs remotely. These innovative solutions have the potential to reduce healthcare costs and provide clinical outcomes comparable or even better than conventional physiotherapy, especially for patients in remote areas.

Akina Cloud, a digital health application that supports therapeutic exercises in people with musculoskeletal disorders, is the first remote app-assisted therapeutic home training solution available in Switzerland. It provides patients with exercise and educational content and facilitates communication between patients and therapists via the application.

The aim of this single-center, observational randomised controlled trial is to show the efficacy of Akina Cloud-mediated physiotherapy in patients with non-specific LBP. Therefore, all enrolled patients receive one prescription of physiotherapy treatment, while patients in the intervention group in contrast to the control group additionally receive the Akina Cloud-mediated physiotherapy. The efficacy of the remote app-assisted physiotherapy through Akina Cloud in regards to reducing the functional disability (primary objective), reducing perceived pain and increasing quality of life (secondary objectives) in comparison to conventional physiotherapy alone is evaluated.

The results of the trial will demonstrate whether app-assisted therapeutic home training is promising approach for managing non-specific low back pain, with the potential to significantly impact patient outcomes and healthcare delivery in Switzerland.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Diagnosis of non-specific low back pain (International Classification of Diseases, 10th edition M54.5) with the pain duration of at least 6 weeks
* Low back pain score of \>3 out of 0-10, based on the numerical pain rating scale at the time of enrolment
* Ability to provide informed consent and participation in the study
* Prescription for physiotherapy
* German speaking
* Presence of an email address, internet connection and a private laptop as well as being able to use the laptop

Exclusion Criteria:

* Inpatient pain therapy (red flags)
* History of lumbar spine surgery during the last year
* Known diagnosis of performance-limiting illnesses as psychological disorders, diseases of the cardiovascular system, etc.
* Known pregnancy

Primary outcomes:
measure: Assessment of the functional disability
timeFrame: Baseline, 0.5, 4, 8, and 12 weeks
Secondary outcomes:
measure: Assessment of pain
timeFrame: Baseline, 0.5, 4, 8, and 12 weeks
measure: Assessment of the quality of life by the Veterans RAND 12-Items Health Survey
timeFrame: 0.5, 4, 8, and 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Spine Surgery, University Hospital Basel, Bethesda Spital
state: Basel-Stadt
Study officials:
affiliation: Department of Spine Surgery, University Hospital Basel
name: Cordula Netzer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: