Chronic Low Back PainNCT05998434
Home-Based Rehabilitation Training for Chronic Low Back Pain Patients
A study of Chronic Low Back Pain, run by First Affiliated Hospital, Sun Yat-Sen University.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Home-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial
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?
Read more
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.
Read the 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.
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Improving Low Back Pain Through Motor Control Training
- Keywords
- Human Key-Point Detection, Core Stability Exercise, digital healthcare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving Low Back Pain Through Motor Control TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the digital therapy | 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. Receives: Behavioral: Improving Low Back Pain Through Motor Control Training |
| traditional exercise therapy | 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. Receives: Behavioral: Improving Low Back Pain Through Motor Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point numeric rating scale（NRS）
NRS;0=no pain, 10=unbearable pain
Measured: baseline，4 weeks and 16 weeks
Secondary outcomes (2)
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
Measured: baseline，4 weeks and 16 weeks
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.
Measured: baseline，4 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jan 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuming Zheng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998434
- Sponsor's protocol ID
- [2023]102
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuming Z, Zhicheng L, Huanjie H, Xinna Z, Rong C, Jiahui P, Liming Y, Xi C, Chuhuai W. Home-based rehabilitation training with human key point detection for chronic low back pain patients: a randomized controlled trial protocol. Trials. 2023 Nov 27;24(1):760. doi: 10.1186/s13063-023-07805-z.
PubMed 38012740
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Rehabilitation Training With Human Key-Point Detection for Chronic Low Back Pain Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05998434
- Acronym / sponsor ID
- [2023]102
- Conditions
- Chronic Low Back Pain
- Keywords
- Human Key-Point Detection, Core Stability Exercise, digital healthcare
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the digital therapy | Experimental | Behavioral: Improving Low Back Pain Through Motor Control TrainingThe 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. |
| traditional exercise therapy | Active comparator | Behavioral: Improving Low Back Pain Through Motor Control TrainingThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improving Low Back Pain Through Motor Control TrainingIn 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. | Behavioural | the digital therapy, traditional exercise therapy |
Primary outcome
11-point numeric rating scale（NRS）
Time frame: baseline，4 weeks and 16 weeks
NRS;0=no pain, 10=unbearable pain
2 secondary outcomes
the Oswestry Disability Index (ODI)
Time frame: baseline，4 weeks and 16 weeks
The 36-item Short Form Health Survey (SF-36)
Time frame: baseline，4 weeks and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Derived from this study: PubMed 38012740Fuming Z, Zhicheng L, Huanjie H, Xinna Z, Rong C, Jiahui P, Liming Y, Xi C, Chuhuai W. Home-based rehabilitation training with human key point detection for chronic low back pain patients: a randomized controlled trial protocol. Trials. 2023 Nov 27;24(1):760. doi: 10.1186/s13063-023-07805-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Low Back Pain, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point numeric rating scale（NRS） (time frame: baseline，4 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05998434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.