Home-Based Rehabilitation Training for Chronic Low Back Pain Patients

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.

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.