Low Back PainNCT06420596
The Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)
A study testing Conventional Physiotherapy and Akina Cloud in people with Low Back Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conventional Physiotherapy and Akina Cloud
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Jul 2024to 19 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Spine Surgery, University Hospital Basel, Bethesda Spital
Basel, Canton of Basel-City, 4052 Basel
About this study
Official title: 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.
Read the 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
- Being tested
- Conventional Physiotherapy, Akina Cloud
- Keywords
- Physiotherapy, Remote app-assisted physiotherapy, Akina Cloud, Musculoskeletal assessment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
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 CloudDevice
Also called Remote physiotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Control intervention | Other | In the control group, patients receive conventional physiotherapy. Receives: 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. Receives: Other: Conventional Physiotherapy; Device: Akina Cloud |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 0.5, 4, 8, and 12 weeks
Secondary outcomes (2)
Assessment of pain
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.
Measured: Baseline, 0.5, 4, 8, and 12 weeks
Assessment of the quality of life by the Veterans RAND 12-Items Health Survey
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.
Measured: 0.5, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start12 Jul 2024
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cordula Netzer, PD Dr. med., Principal investigator, Department of Spine Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420596
- Sponsor's protocol ID
- 2024-00430; mu24Netzer
- Status last verified
- Mar 2026
- First submitted
- 14 May 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Effectiveness of Remote App-assisted Physiotherapy in Patients With Non-specific Low Back Pain (RemotePT)
- ClinicalTrials.gov ID
- NCT06420596
- Acronym / sponsor ID
- 2024-00430; mu24Netzer
- Conditions
- Low Back Pain
- Keywords
- Physiotherapy, Remote app-assisted physiotherapy, Akina Cloud, Musculoskeletal assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control intervention | Other | Other: Conventional PhysiotherapyIn the control group, patients receive conventional physiotherapy. |
| Study Intervention | Experimental | Other: Conventional Physiotherapy, Device: Akina CloudIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyConventional 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. | Other | Control intervention, Study Intervention |
| Akina CloudAlso: Remote physiotherapyAkina 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. | Device | Study Intervention |
Primary outcome
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.
2 secondary outcomes
Assessment of pain
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cordula Netzer, PD Dr. med. principal investigator
Department of Spine Surgery, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Akina Cloud in people with Low Back Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the functional disability (time frame: Baseline, 0.5, 4, 8, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.