Efficacy of Internet-Based Cognitive Behavioral Therapy for Back Muscle Strength Loss, Chronic Pain, and Poor Patient Recovery Perceptions After Lumbar Fusion
NCT ID: NCT07030582
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-12-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The intervention group
The research team developed a comprehensive core muscle training protocol based on internet-delivered cognitive behavioral therapy through the digital rehabilitation platform.
Internet-delivered cognitive behavioral therapy
The intervention group received a comprehensive core muscle training protocol delivered through a digital rehabilitation platform from hospital admission to 6 months post-surgery. The protocol began with initial screening, including online assessments of cognitive misconceptions, kinesiophobia, and posture analysis. Pain-related cognitive restructuring was addressed through virtual reality sessions, educational videos, and mindfulness breathing guidance. Behavioral activation incorporated graded exposure therapy with EMG biofeedback, interactive knowledge quizzes, and peer modeling. Exercise skills were developed through personalized progressive training with real-time video guidance, and protocols were adjusted based on mid-term assessments. Behavioral reinforcement strategies included recovery support groups, compliance tracking, and integration of exercises into daily activities. A three-tier warning system (Red/Yellow/Green) was implemented to monitor safety and compliance, trigger
Basic Postoperative Care
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
The control group
The control group received conventional postoperative care interventions
Basic Postoperative Care
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
Conventional Postoperative Care
The control group received conventional postoperative care, which included the establishment of a WeChat support group and provision of a rehabilitation manual focusing on core muscle training on the first postoperative day. Physical therapists provided individualized bedside instruction to ensure proper exercise techniques. Structured follow-up was conducted via telephone or social media (weekly during the first month, then monthly from months 2-6, with each session lasting at least 15 minutes) to provide psychological support and exercise guidance through relaxation techniques and individualized core muscle training progression.
Interventions
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Internet-delivered cognitive behavioral therapy
The intervention group received a comprehensive core muscle training protocol delivered through a digital rehabilitation platform from hospital admission to 6 months post-surgery. The protocol began with initial screening, including online assessments of cognitive misconceptions, kinesiophobia, and posture analysis. Pain-related cognitive restructuring was addressed through virtual reality sessions, educational videos, and mindfulness breathing guidance. Behavioral activation incorporated graded exposure therapy with EMG biofeedback, interactive knowledge quizzes, and peer modeling. Exercise skills were developed through personalized progressive training with real-time video guidance, and protocols were adjusted based on mid-term assessments. Behavioral reinforcement strategies included recovery support groups, compliance tracking, and integration of exercises into daily activities. A three-tier warning system (Red/Yellow/Green) was implemented to monitor safety and compliance, trigger
Basic Postoperative Care
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
Conventional Postoperative Care
The control group received conventional postoperative care, which included the establishment of a WeChat support group and provision of a rehabilitation manual focusing on core muscle training on the first postoperative day. Physical therapists provided individualized bedside instruction to ensure proper exercise techniques. Structured follow-up was conducted via telephone or social media (weekly during the first month, then monthly from months 2-6, with each session lasting at least 15 minutes) to provide psychological support and exercise guidance through relaxation techniques and individualized core muscle training progression.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
* Surgical procedures performed by the same surgical team
* willingness to comply with the study protocol and restrictions
* availability of a home WiFi connection
Exclusion Criteria
* postoperative infection or revision surgery
* presence of cauda equina syndrome
* diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
* coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.
18 Years
55 Years
ALL
No
Sponsors
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Jiawei Jiang
OTHER
Responsible Party
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Jiawei Jiang
Attending Physician
Locations
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Affiliated 2 Hospital of Nantong University
Nantong, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TWang
Identifier Type: -
Identifier Source: org_study_id
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