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Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients (AVA-PREPA)

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AXOMOVE Therapy Medical Device
Sponsored by
Axomove
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient aged 18-65 years, Patients with subacute or chronic low back pain, day hospital follow-up (HDJ) or weekday hospital with a planned return home within 2 weeks of the inclusion visit (J0), Patient with common low back pain for at least 6 weeks before hospitalization, Patient having a smartphone, tablet/ or computer (compatible with the technical requirements of the DM) and having the possibility to connect (via a telephone subscription or a WIFI connection), Patient agreeing to install the Axomove Therapy® application and agreeing to follow the study protocol, Patient with physical, sensory and cognitive ability to use an application (digital tools) on a smartphone, tablet or computer and perform physical exercise programs, A patient who is a member of, or in receipt of, a social security scheme. Exclusion Criteria: Patients who are unable to understand, read or speak French, Inability to receive informed information, A patient with a sensory, visual or tactile impairment that prevents the correct use of a smartphone, tablet and/or computer, or prevents the exercise from being carried out safely, Patient with suspected or proven serious pathology such as recent vertebral fractures (less than 6 months), infection, malignant tumors and/or radiculopathy, Patient with a history of rheumatic inflammatory disease, Patient with true radiculalgia, Patient with scoliosis > 30°, Patient with lumbar surgery in the past 12 months, Pregnant patient, parturient or breastfeeding, Patient under legal protection (guardianship, curatorship), A patient with a serious and/or uncontrolled illness that, in the opinion of the investigator, could result in unacceptable safety risks or compromise protocol compliance, for example: an active or uncontrolled infection.

Sites / Locations

  • CHRU de LILLERecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AXOMOVE Therapy

Routine care

Arm Description

Use of a web and mobile application for remote monitoring and rehabilitation

Current rehabilitation support care

Outcomes

Primary Outcome Measures

Efficacy of AXOMOVE Therapy
Functional capacity of patients measured through the Oswestry Disability Index score

Secondary Outcome Measures

Level of patient physical activity
Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF)
Quality of life
Quality of life measured by the EQ5D5L questionnaire
Quality of life
Quality of life measured by the SF36 questionnaire
Efficacy of AXOMOVE Therapy
Functional capacity of patients measured through the Oswestry Disability Index score (ODI)

Full Information

First Posted
April 5, 2023
Last Updated
July 19, 2023
Sponsor
Axomove
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1. Study Identification

Unique Protocol Identification Number
NCT05910463
Brief Title
Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients
Acronym
AVA-PREPA
Official Title
Assessment of the Impact of the Axomove Therapy® Medical Device on Subacute or Chronic Low Back Pain Patients Leaving Rehabilitation Centres to Facilitate Self-rehabilitation: a Multicentre Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axomove

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
An evaluation study of the impact of the Axomove Therapy® medical device on subacute or chronic low back pain patients leaving rehabilitation centres to facilitate self-rehabilitation. A prospective, randomized, open-label, multicentre study whose main objective is to evaluate the effectiveness of the Axomove Therapy Medical Device on disability reduction (Oswestry disability index score) patients with subacute or chronic low back pain requiring rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXOMOVE Therapy
Arm Type
Experimental
Arm Description
Use of a web and mobile application for remote monitoring and rehabilitation
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Current rehabilitation support care
Intervention Type
Other
Intervention Name(s)
AXOMOVE Therapy Medical Device
Intervention Description
Personalized exercise programs for the self-rehabilitation of low back pain patients
Primary Outcome Measure Information:
Title
Efficacy of AXOMOVE Therapy
Description
Functional capacity of patients measured through the Oswestry Disability Index score
Time Frame
14 weeks (105 days)
Secondary Outcome Measure Information:
Title
Level of patient physical activity
Description
Level of physical activity measured by the international physical activity questionnaire (IPAQ-SF)
Time Frame
day 0 (inclusion), day 15, day 45 and day 105
Title
Quality of life
Description
Quality of life measured by the EQ5D5L questionnaire
Time Frame
day 0 (inclusion), day 15, day 45 and day 105
Title
Quality of life
Description
Quality of life measured by the SF36 questionnaire
Time Frame
day 0 (inclusion), day 15, day 45 and day 105
Title
Efficacy of AXOMOVE Therapy
Description
Functional capacity of patients measured through the Oswestry Disability Index score (ODI)
Time Frame
day 0 (inclusion), day 15, day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient aged 18-65 years, Patients with subacute or chronic low back pain, day hospital follow-up (HDJ) or weekday hospital with a planned return home within 2 weeks of the inclusion visit (J0), Patient with common low back pain for at least 6 weeks before hospitalization, Patient having a smartphone, tablet/ or computer (compatible with the technical requirements of the DM) and having the possibility to connect (via a telephone subscription or a WIFI connection), Patient agreeing to install the Axomove Therapy® application and agreeing to follow the study protocol, Patient with physical, sensory and cognitive ability to use an application (digital tools) on a smartphone, tablet or computer and perform physical exercise programs, A patient who is a member of, or in receipt of, a social security scheme. Exclusion Criteria: Patients who are unable to understand, read or speak French, Inability to receive informed information, A patient with a sensory, visual or tactile impairment that prevents the correct use of a smartphone, tablet and/or computer, or prevents the exercise from being carried out safely, Patient with suspected or proven serious pathology such as recent vertebral fractures (less than 6 months), infection, malignant tumors and/or radiculopathy, Patient with a history of rheumatic inflammatory disease, Patient with true radiculalgia, Patient with scoliosis > 30°, Patient with lumbar surgery in the past 12 months, Pregnant patient, parturient or breastfeeding, Patient under legal protection (guardianship, curatorship), A patient with a serious and/or uncontrolled illness that, in the opinion of the investigator, could result in unacceptable safety risks or compromise protocol compliance, for example: an active or uncontrolled infection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie POUPARD
Phone
0675385354
Email
lucie.poupard@axomove.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie WIECZOREK, MD
Organizational Affiliation
CHU de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de LILLE
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie WIECZOREZ, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing the Impact of the Axomove Therapy Medical Device on Low Back Pain Patients

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