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

NCT06420596 | Completed

• 1 other identifier: 2024-00430; mu24Netzer
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Physiotherapy; Remote app-assisted physiotherapy; Akina Cloud; Musculoskeletal assessment

Outcome Measures

Primary Outcomes (1)

• Assessment of the functional disability

  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 Outcomes (2)

• Assessment of pain

  Baseline, 0.5, 4, 8, and 12 weeks

• Assessment of the quality of life by the Veterans RAND 12-Items Health Survey

  0.5, 4, 8, and 12 weeks

Study Arms (2)

Control intervention

OTHER

In the control group, patients receive conventional physiotherapy.

Other: Conventional Physiotherapy

Study Intervention

EXPERIMENTAL

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; Device: Akina Cloud

Interventions

Akina Cloud 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.

Also known as: Remote physiotherapy

Study Intervention

Conventional Physiotherapy 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.

Control intervention; Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Spine Surgery, University Hospital Basel, Bethesda Spital

Basel, Canton of Basel-City, 4052 Basel, Switzerland

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cordula Netzer, PD Dr. med.

  Department of Spine Surgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: July 12, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CH (1)