Efficacy of Internet-Based Cognitive Behavioral Therapy for Back Muscle Strength Loss, Chronic Pain, and Poor Patient Recovery Perceptions After Lumbar Fusion

NCT07030582 | Recruiting

• 1 other identifier: TWang
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Internet-Based Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  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 Outcomes (4)

• Lumbar Function

  The JOA scores were collected at baseline, 3 months, and 6 months post-intervention.

• Trunk Shift (Spinal Alignment)

  Measurements were obtained at baseline, 3 months, and 6 months post-intervention.

• Pelvic Torsion

  Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.

• Maximum Vertebral Rotation

  Measurements will be obtained at baseline, 3 months, and 6 months post-intervention.

Study Arms (2)

The intervention group

EXPERIMENTAL

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

ACTIVE COMPARATOR

The control group received conventional postoperative care interventions

Behavioral: Basic Postoperative Care; Behavioral: Conventional Postoperative Care

Interventions

Internet-delivered cognitive behavioral therapy 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

The intervention group

Basic Postoperative Care 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 intervention group

Conventional Postoperative Care 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.

The control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiawei Jiang: lead

Study Sites (1)

Affiliated 2 Hospital of Nantong University

Nantong, Jiangsu, 0513, China

RECRUITING

Central Study Contacts

Tingting Wang

CONTACT

15950804163; 15950804163@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 22, 2025
• Study Start: December 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)