Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651099
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain Randomized Controlled Trial eBack Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eBack
Brief Summary:
The aim of this trial is to assess the effectiveness and cost-effectiveness of a supervised and more personalised mhealth intervention compared with conventional exercise therapy in people with chronic non-specific low back pain
Detailed Description:
Background Chronic non-specific low back pain CNLBP is a prevalent and costly condition that encourages research into self-management strategies Mobile health mhealth applications are promising interventions but current evidence on their effectiveness is still conflicting The aim is to investigate the cost-effectiveness of a supervised and personalized mhealth intervention compared with conventional exercise therapy in individuals with CNLBP Methods A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres Adults aged between 18 and 59 years and with self-reported LBP 12 weeks will be included Following the collection of baseline data participants will be randomly assigned to one of two groups using a permuted block randomization 1 mhealth 2 Conventional exercise delivered through a booklet Outcome assessments will be conducted following randomisation at five distinct time points resulting in a total follow-up period of 12 months The primary clinical outcome is disability Roland-Morris Disability Questionnaire while secondary outcomes include pain NRS utility EQ5D5L fears and beliefs FABQ self-efficacy PSEQ and global perceived effect A sample size of 146 participants was estimated 73 allocated to each group in order to detect a 2-point between-groups difference on disability A cost-effectiveness study will be conducted alongside the trial comparing the two interventions in terms of costs and clinical outcomes Discussion While mhealth applications show promise as interventions for people with LBP there is still a gap regarding the type of delivery and personalisation strategies This study investigates whether the implementation of stratified and tailored care within a mobile application based on patient-reported outcome measures and supervised by a physiotherapist is costeffective
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None