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Home-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial

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What is being tested

Improving Low Back Pain Through Motor Control Training

Behavioral
Who is being recruted

From 18 to 60 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial investigates the effectiveness of a digital therapy app compared to traditional exercise therapy in helping individuals manage chronic low back pain. Chronic low back pain can significantly impact daily life, and finding effective treatment methods is crucial for improving quality of life for those affected. The study involves people with long-term low back pain and aims to determine whether a digital approach can be as effective or better than conventional methods. Understanding which method offers better pain relief and improved back function could lead to enhanced treatment options for individuals struggling with this condition. Participants in the trial are randomly assigned to either use a digital therapy app or receive traditional exercise therapy. Those in the digital group use an app on their smartphones that guides them through specific exercises at home, while the traditional group attends in-person sessions with a therapist. Both groups perform exercises aimed at improving core stability, with researchers monitoring how well they follow the routines and any changes in their pain and back function. Data integrity is a priority, with measures in place to ensure accurate tracking of results, contributing to reliable findings on the effectiveness of each therapy method.

Official TitleHome-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial
NCT05998434
Principal SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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.

4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The participants randomly assigned to the intervention group will receive home-based exercise training with human key-point detection.They will be instructed to complete a minimum of three sports training sessions per week at their preferred time and location.The exercise prescription will be formulated based on previous comprehensive studies, encompassing exercises targeting strength, balance, flexibility, and mobility.Human key point detection technology accurately estimates 25 key points of the human body in pictures or videos using visual detection.

Group II

Active Comparator
The participants randomly assigned to the control group will receive traditional face-to-face exercise instruction. An experienced therapist( 10 years of experience) will be arranged to provide the subjects with 20-30 minutes of exercise instruction three times a week for four weeks. The training sessions were scheduled to start at 4 p.m. on Monday, Wednesday, and Friday of each week. The exercise training content selected for the control group will be consistent with that of the intervention group.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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