Home-Based Rehabilitation Training for Chronic Low Back Pain Patients

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998434
• Other study ID #: [2023]102
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Traditional Exercise Therapy Group:

Participants in this group will receive traditional exercise therapy guided by a physical therapist. They will attend in-person sessions at a designated clinic, where they will receive personalized exercise recommendations and instructions. Similar to the digital therapy group, researchers will monitor exercise adherence and track changes in back function and pain intensity.

Quality Assurance and Data Management:

The study will implement a comprehensive quality assurance plan to ensure the accuracy and reliability of collected data. This plan will include data validation procedures, site monitoring, and auditing. Data checks will be conducted to identify inconsistencies or errors in the collected data. Source data verification will be employed to cross-reference registry data with external sources, such as medical records.

Data Dictionary and Standard Operating Procedures:

A data dictionary will be developed, detailing each variable used in the registry. This will include the source of the variable, coding information, and normal ranges if relevant. Standard Operating Procedures (SOPs) will be established to govern registry operations and analysis activities, covering patient recruitment, data collection, data management, analysis, adverse event reporting, and change management.

Sample Size and Missing Data:

A sample size assessment will be conducted to determine the number of participants or participant years required to demonstrate a statistically significant effect. A plan for handling missing data will be devised to address situations where variables are missing or inconsistent due to various reasons.

Statistical Analysis Plan:

A detailed statistical analysis plan will be developed, outlining the analytical principles and statistical techniques to address primary and secondary objectives outlined in the study protocol or plan. This will guide the analysis of data collected throughout the trial.

In summary, this comprehensive protocol describes the structure, procedures, and quality measures of a clinical trial comparing the effectiveness of a digital therapy and traditional exercise therapy in managing chronic low back pain. The implementation of rigorous quality assurance procedures and data management strategies will ensure the reliability and validity of the study's findings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 60 years;

2. Duration of low back pain of at least 12 weeks;

3. Strong willingness to participate in the study and signed informed consent.

Exclusion Criteria:

1. 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);

2. NRS score less than 4 points;

3. Regular engagement in core stability training in the past four weeks;

4. Inability to independently complete the Chinese electronic questionnaire.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Improving Low Back Pain Through Motor Control Training
In the digital healthcare group, participants utilized app-based online motor control training. In contrast, participants in the traditional treatment group underwent motor control training under the guidance of healthcare professionals at the hospital.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-point numeric rating scale(NRS)	NRS;0=no pain, 10=unbearable pain	baseline,4 weeks and 16 weeks
Secondary	the Oswestry Disability Index (ODI)	The ODI evaluated disability across 10 domains, encompassing pain intensity and functional abilities related to personal care, lifting, walking, sitting, standing, sleeping, sexual activities, social life, and traveling. Each domain was rated on a 6-point scale ranging from 0 to 5. A score of 0 indicated the highest level of functioning, while a score of 50 indicated total disability	baseline,4 weeks and 16 weeks
Secondary	The 36-item Short Form Health Survey (SF-36)	it evaluates an individual's physical, mental, and social health experiences across eight domains, including Physical Functioning, Mental Health, and more. With 36 questions, responses are scored from 0 to 100, reflecting higher scores for better health status. Its brevity, versatility, and comprehensive health dimension coverage are notable advantages. The SF-36 finds applications in clinical practice, epidemiology, and health outcome studies, aiding in diagnosis, treatment, and policy decisions.	baseline,4 weeks and 16 weeks