Home-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 104
- Primary Endpoint
- 11-point numeric rating scale（NRS）
Study Overview
Brief Summary
The goal of this clinical trial is to test the effectiveness of a new digital therapy for managing chronic low back pain in adults. The main questions it aims to answer are:
- Does the digital therapy improve back function and reduce pain intensity in participants with chronic low back pain?
- How does the digital therapy's impact compare to traditional exercise therapy?
Participants in this study will be asked to use the digital therapy app on their smartphones. They will receive guided core stability exercises through the app and will be encouraged to perform these exercises at home. Researchers will assess participants' progress by monitoring their exercise adherence and tracking changes in their back function and pain intensity over time.
To compare the effects of the digital therapy, some participants will follow a traditional exercise therapy program guided by a physical therapist. Researchers will compare the outcomes of these two groups to determine whether the digital therapy is as effective as traditional therapy in improving back function and reducing pain intensity in individuals with chronic low back pain.
Detailed Description
This detailed description provides an extended overview of the protocol for the clinical trial focused on testing the efficacy of a digital therapy for managing chronic low back pain. The trial seeks to compare the digital therapy's impact against traditional exercise therapy in individuals with chronic low back pain.
Participants and Procedures:
Participants will be recruited based on specific eligibility criteria, including age, medical history, and duration of chronic low back pain. After obtaining informed consent, participants will be randomly assigned to one of two groups: the digital therapy group or the traditional exercise therapy group.
Digital Therapy Group:
Participants in this group will receive access to a digital therapy app on their smartphones. The app will guide them through core stability exercises, providing step-by-step instructions and visual demonstrations. Participants will be encouraged to perform these exercises regularly at home. Researchers will monitor participants' exercise adherence and collect data on their back function and pain intensity over the study period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 18 and 60 years;
- •Duration of low back pain of at least 12 weeks;
- •Strong willingness to participate in the study and signed informed consent.
Exclusion Criteria
- •Presence of potential "red flag signs" (e.g., unilateral leg pain and numbness consistent with nerve distribution, intermittent claudication, unexplained sudden weight loss, nocturnal lumbar pain, traumatic lumbago);
- •NRS score less than 4 points;
- •Regular engagement in core stability training in the past four weeks;
- •Inability to independently complete the Chinese electronic questionnaire.
Outcomes
Primary Outcomes
11-point numeric rating scale（NRS）
Time Frame: baseline，4 weeks and 16 weeks
NRS;0=no pain, 10=unbearable pain
Secondary Outcomes
- the Oswestry Disability Index (ODI)(baseline，4 weeks and 16 weeks)
- The 36-item Short Form Health Survey (SF-36)(baseline，4 weeks and 16 weeks)
Investigators
Fuming Zheng
Principal Investigator
First Affiliated Hospital, Sun Yat-Sen University