## Protocol Section
### Identification Module
**NCT ID:** NCT06420596

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 2024-00430; mu24Netzer
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Basel, Switzerland
### Status Module
#### Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Basel, Switzerland

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Low Back Pain

**Keywords:**

- Physiotherapy

- Remote app-assisted physiotherapy

- Akina Cloud

- Musculoskeletal assessment

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In the control group, patients receive conventional physiotherapy.

**Intervention Names:**

- Other: Conventional Physiotherapy

**Label:** Control intervention

**Type:** OTHER

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Conventional Physiotherapy

- Device: Akina Cloud

**Label:** Study Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control intervention

- Study Intervention

**Description:** 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.

**Name:** Conventional Physiotherapy

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Study Intervention

**Description:** 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.

**Name:** Akina Cloud

**Other Names:**

- Remote physiotherapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Assessment of the functional disability

**Time Frame:** Baseline, 0.5, 4, 8, and 12 weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** Assessment of pain

**Time Frame:** Baseline, 0.5, 4, 8, and 12 weeks

**Description:** 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.

**Measure:** Assessment of the quality of life by the Veterans RAND 12-Items Health Survey

**Time Frame:** 0.5, 4, 8, and 12 weeks

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cordula.netzer@usb.ch

**Name:** Cordula Netzer, PD Dr. med.

**Phone:** +41 61 265 78 30

**Role:** CONTACT

**Contact 2:**

**Email:** mandy.mathys@usb.ch

**Name:** Mandy Mathys

**Phone:** +41 61 55 65 279

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Basel

**Contacts:**

***Contact 1:***

- **Email:** cordula.netzer@usb.ch

- **Name:** Cordula Netzer, PD Dr. med.

- **Phone:** +41 61 265 78 30

- **Role:** CONTACT

***Contact 2:***

- **Email:** Mandy.Mathys@usb.ch

- **Name:** Mandy Mathys

- **Phone:** +41 61 55 65 279

- **Role:** CONTACT

***Contact 3:***

- **Name:** Cordula Netzer, PD Dr. med.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Switzerland

**Facility:** Department of Spine Surgery, University Hospital Basel, Bethesda Spital

**State:** Basel-Stadt

**Zip:** 4052 Basel

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Spine Surgery, University Hospital Basel

**Name:** Cordula Netzer, PD Dr. med.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4714

- Name: Back Pain

- Relevance: HIGH

- As Found: Back Pain

- ID: M19433

- Name: Low Back Pain

- Relevance: HIGH

- As Found: Low Back Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001416

- Term: Back Pain

- ID: D000017116

- Term: Low Back Pain

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
