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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 55 years
• All sexes
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Internet-Based Cognitive Behavioral Therapy

Being tested

Internet-delivered cognitive behavioral therapy, Basic Postoperative Care, Conventional Postoperative Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Internet-delivered cognitive behavioral therapyBehavioural

  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 CareBehavioural

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

• Conventional Postoperative CareBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: The TSK scores were collected at baseline and at 1 week, 1 month, 3 months, and 6 months post-intervention.

2. 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).

   Measured: Exercise adherence scores were collected at baseline and at follow-up intervals of 1 week, 1 month, 3 months, and 6 months post-intervention.

3. 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.

   Measured: Pain scores were collected at baseline and follow-up intervals of 1 week (at discharge), 1 month, 3 months, and 6 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted22 Jun 2025
2. Study start1 Dec 2023
3. Primary completion31 Jul 2027 (estimated)
4. Study completion31 Dec 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Internet-Based Cognitive Behavioral TherapyStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.