An interventional study of Internet-delivered cognitive behavioral therapy and Basic Postoperative Care in Internet-Based Cognitive Behavioral Therapy, sponsored by Jiawei Jiang. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-22.
Sponsored by Jiawei Jiang · Not applicable, Interventional, and Treatment
This study aims to develop an Internet-based Cognitive Behavioral Therapy protocol for core muscle training, based on an understanding of factors impeding postoperative core muscle training in lumbar surgery patients. The protocol is designed to reconstruct patients' cognition, eliminate adverse behaviors, and promote healthy behaviors such as core muscle training among LDH patients. The ultimate objectives are to alleviate postoperative pain, enhance lumbar stability, and facilitate disease rehabilitation in patients following lumbar surgery.
2,928 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
The research team developed a comprehensive core muscle training protocol based on internet-delivered cognitive behavioral therapy through the digital rehabilitation platform.
Behavioral: Internet-delivered cognitive behavioral therapy · Behavioral: Basic Postoperative Care
The control group received conventional postoperative care interventions
Behavioral: Basic Postoperative Care · Behavioral: Conventional Postoperative Care
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
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
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.
TSK Scores
The Tampa Scale of Kinesiophobia (TSK) was administered to evaluate kinesiophobia in both groups before and after intervention. The TSK is a validated 17-item questionnaire, with each item scored on a 4-point scale. The TSK consists of 17 items with a total score ranging from 17 to 68 points, with higher scores indicating greater severity of kinesiophobia.
Time frame: The TSK scores were collected at baseline and at 1 week, 1 month, 3 months, and 6 months post-intervention.
Exercise Adherence
The Orthopedic Patient Exercise Compliance Scale total score (ranging from 15 to 75 points) will be used to evaluate patients' adherence to postoperative functional exercises, using a 15-item questionnaire that assesses three dimensions (physical, psychological, and active learning aspects). Each item is scored on a 5-point Likert scale (1 = completely unable to 5 = completely able), with higher total scores indicating better exercise compliance (\>55 points represents high adherence, 20-55 points indicates partial adherence, and \<20 points indicates low adherence).
Time frame: Exercise adherence scores were collected at baseline and at follow-up intervals of 1 week, 1 month, 3 months, and 6 months post-intervention.
Pain Intensit
Pain severity will be measured using the Numerical Rating Scale (NRS) total score (ranging from 0 to 10 points), a validated 11-point scale for pain assessment. Pain levels are categorized according to the following scoring criteria: 0 = no pain, 1-3 points = mild pain, 4-6 points = moderate pain, 7-9 points = severe pain, and 10 points = extreme pain, with higher scores indicating greater pain severity.
Time frame: Pain scores were collected at baseline and follow-up intervals of 1 week (at discharge), 1 month, 3 months, and 6 months post-intervention.
Lumbar Function
Lumbar functional status will be measured using the Japanese Orthopaedic Association (JOA) scale total score (ranging from 0 to 29 points), a comprehensive assessment tool that evaluates four functional domains: subjective symptoms (low back pain, leg pain, and gait), clinical signs (straight leg raising, sensory disturbance, and motor dysfunction), restriction of activities of daily living, and bladder function, with lower scores indicating more severe functional impairment
Time frame: The JOA scores were collected at baseline, 3 months, and 6 months post-intervention.
Trunk Shift (Spinal Alignment)
Lateral deviation of vertebra prominens from the midline will be measured using the DIERS FORMETRIC III 4D motion analysis system (DICMA V2.x.x software, DIERS Medical Systems, Beijing, China). The measurement is expressed in millimeters (mm), with larger values indicating greater lateral deviation.
Time frame: Measurements were obtained at baseline, 3 months, and 6 months post-intervention.
Pelvic Torsion
Rotational angle between posterior superior iliac spines will be measured using the same DIERS FORMETRIC III 4D system. The measurement is expressed in degrees (°), with larger values indicating greater pelvic rotation.
Time frame: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.
Maximum Vertebral Rotation
The sum of maximum vertebral rotation angles will be measured using the same DIERS FORMETRIC III 4D system. The measurement is expressed in degrees (°), with larger values indicating greater vertebral rotation.
Time frame: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.
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