The Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)

NCT ID: NCT06420596

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2025-06-19

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control intervention

In the control group, patients receive conventional physiotherapy.

Group Type: OTHER

Conventional Physiotherapy

Intervention Type: OTHER

Conventional physiotherapy is one prescription of 9 in person physiotherapy sessions (according to FMH Switzerland guidelines). The frequency of the physiotherapy sessions are at the discretion of the treating clinician, but the recommendation is 1 to 2 sessions per week.

Study Intervention

In the interventional group, patients receive 12 weeks of a remote physiotherapy via Akina Cloud in addition to conventional physiotherapy (treatment according to FMH Switzerland guidelines). Patients are encouraged to complete at least three app-guided training sessions per week.

Group Type: EXPERIMENTAL

Conventional Physiotherapy

Intervention Type: OTHER

Conventional physiotherapy is one prescription of 9 in person physiotherapy sessions (according to FMH Switzerland guidelines). The frequency of the physiotherapy sessions are at the discretion of the treating clinician, but the recommendation is 1 to 2 sessions per week.

Akina Cloud

Intervention Type: DEVICE

Akina Cloud is a digital health application that supports therapeutic exercises in people with musculoskeletal disorders. It is the first app-supported physiotherapy solution available in Switzerland.

Interventions

Conventional Physiotherapy

Conventional physiotherapy is one prescription of 9 in person physiotherapy sessions (according to FMH Switzerland guidelines). The frequency of the physiotherapy sessions are at the discretion of the treating clinician, but the recommendation is 1 to 2 sessions per week.

Intervention Type: OTHER

Akina Cloud

Akina Cloud is a digital health application that supports therapeutic exercises in people with musculoskeletal disorders. It is the first app-supported physiotherapy solution available in Switzerland.

Intervention Type: DEVICE

Other Intervention Names

Remote physiotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cordula Netzer, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Spine Surgery, University Hospital Basel

Locations

Department of Spine Surgery, University Hospital Basel, Bethesda Spital

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2024-00430; mu24Netzer

Identifier Type: -

Identifier Source: org_study_id