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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Internet-Based Cognitive Behavioral Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Internet-delivered cognitive behavioral therapy

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Basic Postoperative Care

Intervention Type BEHAVIORAL

All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.

Conventional Postoperative Care

Intervention Type BEHAVIORAL

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type 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) to provide psychological support and exercise guidance through relaxation techniques and individualized core muscle training progression.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jiawei Jiang

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiawei Jiang

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Tingting Wang

Role: CONTACT

15950804163

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tingting Wang

Role: primary

15950804163

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TWang

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Optimize Low Back Pain
NCT03859713 UNKNOWN PHASE3
Cognitive-Behavioral Physical Therapy
NCT01131611 COMPLETED PHASE1/PHASE2