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

March 6, 2026 updated by: University Hospital, Basel, Switzerland

A Randomised Controlled Trial on the Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4052 Basel
        • Department of Spine Surgery, University Hospital Basel, Bethesda Spital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control intervention
In the control group, patients receive conventional physiotherapy.
Other: 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.
Experimental: 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.
Other: 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.
Device: 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.
Other Names:
  • Remote physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the functional disability
Time Frame: Baseline, 0.5, 4, 8, and 12 weeks
The patient's functional disability is assessed using the Oswestry Disability Index (ODI). The ODI is a patient-completed questionnaire that provides a subjective percentage score indicating the level of disability in daily activities. Scores range from 0 to 100, with higher scores indicating greater disability. To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective than conventional physiotherapy alone, the average ODI scores between the two groups are compared.
Baseline, 0.5, 4, 8, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain
Time Frame: Baseline, 0.5, 4, 8, and 12 weeks
The pain intensity is assessed by asking the patient to rate his/her pain on a Numerical Rating Scale (ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain). To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective in reducing perceived pain than conventional physiotherapy alone, the average values between the two groups are compared.
Baseline, 0.5, 4, 8, and 12 weeks
Assessment of the quality of life by the Veterans RAND 12-Items Health Survey
Time Frame: 0.5, 4, 8, and 12 weeks
The health-related quality of life is assessed using the Veterans RAND 12-Items Health Survey (VR-12), which measures various aspects of physical and mental health, generating Physical Component Summary and Mental Component Summary scores. Scores range from 0 to 100, with higher scores indicating better health outcomes. To evaluate whether the remote app-assisted physiotherapy using Akina Cloud in addition to conventional physiotherapy is more effective in increasing the quality of life than conventional physiotherapy alone, the average scores between the two groups are compared.
0.5, 4, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Cordula Netzer, PD Dr. med., Department of Spine Surgery, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2024

Primary Completion (Actual)

June 19, 2025

Study Completion (Actual)

June 19, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00430; mu24Netzer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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