Recruiting NCT07030582
Efficacy of Internet-Based Cognitive Behavioral Therapy for Back Muscle Strength Loss, Chronic Pain, and Poor Patient Recovery Perceptions After Lumbar Fusion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Internet-delivered cognitive behavioral therapy, Basic Postoperative Care, Conventional Postoperative Care.
- Who it may be relevant to
- Registry conditions: Internet-Based Cognitive Behavioral Therapy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral 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 - Behavioral Basic Postoperative Care
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period. - Behavioral 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)
Primary outcome measures
- TSK Scores [Time frame: The TSK scores were collected at baseline and at 1 week, 1 month, 3 months, and 6 months post-intervention.]
- Exercise 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 [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.]
Secondary outcome measures (4)
- Lumbar Function [Time frame: The JOA scores were collected at baseline, 3 months, and 6 months post-intervention.]
- Trunk Shift (Spinal Alignment) [Time frame: Measurements were obtained at baseline, 3 months, and 6 months post-intervention.]
- Pelvic Torsion [Time frame: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.]
- Maximum Vertebral Rotation [Time frame: Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.]
Eligibility criteria
Inclusion criteria
- age between 18 and 55 years
- 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
- lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated 2 Hospital of Nantong University — Nantong
Publications
- Wang T, Jiang J, Li C, Xuan Q, Sun L, Xu G, Gu H, Gao H. Effects of internet-based cognitive behavioral therapy on kinesiophobia, exercise adherence, and back muscle function after lumbar fusion surgery. BMC Musculoskelet Disord. 2026 Mar 18;27(1):357. doi: 10.1186/s12891-026-09617-z. PMID 41845320
Identifiers
NCT: NCT07030582 · TWang