Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery

Not Applicable

• Conditions: Low Back Pain; Lumbar Degenerative Disease
• Interventions: Behavioral: Perioperative Rehabilitation

• Registration Number: NCT04120532
• Lead Sponsor: Taipei Medical University Shuang Ho Hospital

Brief Summary

Lumbar degenerative disease surgery has been a routine clinical operation, and has good treatment effects. Although the patient's neurological symptoms improve after surgery, many patients still have postoperative muscle soreness. The postoperative rehabilitation intervention for the patients receiving traditional lumbar surgery has been confirmed to effectively improve pain and disability. However, in recent years, minimally invasive lumbar spinal surgery has gradually replaced traditional surgery, postoperative pain has been greatly reduced. Therefore, patients have the opportunity to receive early intervention in rehabilitation, but there is no standardization process for rehabilitation of minimally invasive lumbar spine surgery. Therefore, this study aims to establish a health education program for patients receiving minimally invasive lumbar spinal surgery, and conduct clinical trials to test its effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-25
• Status Verified: 2019-10
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-07
• Last Update Submitted: 2019-10-07
• Study First Posted: 2019-10-09
• Last Update Posted: 2019-10-09
• Primary Completion: 2021-10
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 45 and 90 years old.
• Low back pain has been persisting at least 3 months.
• Clinical degeneration diagnosis supports the need of MI-TLIF.
• Able to understand Chinese.

Exclusion Criteria

• Emergency surgery.
• Unstable vital sign.
• Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
• Had spinal surgery before.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education group	Perioperative Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Change of Oswestry Disability Index	The day before operation day, and 1, 3, 6 months after surgery	This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Change of Short Form 12 version 2	The day before operation day, and 1, 3, 6 months after surgery	This scale evaluates subject's health-related quality of life. We will record the subscales: physical component summary (PCS) and mental component summary (MCS). Higher values represent a better outcome.
Change of Functional reach test	The day before operation day, and 1, 3, 6 months after surgery	It is a dynamic measure of balance. A 100 cm yardstick will be horizontally set on the wall with the acromion height. The patient will be asked to make a fit and reach forward as far as possible without moving his/her feet. It will be measured twice and the better outcome will be recorded.
Change of Visual Analogue Scale	The day before operation day, and 1, 3, 6 months after surgery	This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.
Change of Timed Up and Go test	The day before operation day, and 1, 3, 6 months after surgery	It was developed to measure subjects' balance and mobility. The patient starts with a sitting position, stands up, walks a 3-meter distance, turns, walks back, and sits down. He/She will be encouraged to finish it safely as soon as possible. A shorter time indicates better function.
Change of 15-m walk test	The day before operation day, and 1, 3, 6 months after surgery	Gait speed shows good reliability and is valid to assess physical mobility. A 15-mile straight line will be mounted on a flat surface. The patient will be required to walk down the line at the maximal speed. He/She will be encouraged to finish it safely as soon as possible. A shorter time indicates better function.
Change of 30-second Chair Rise	The day before operation day, and 1, 3, 6 months after surgery	It is used to evaluate the lower limb function and strength relating to the daily activities. The patient starts with a sitting position, and need to repeat stand-to-sit movements. He/She will be encouraged to move safely as soon as possible in 30 minutes. Higher number indicates better function.

Secondary Outcome Measures

Name	Time	Method
Narcotic use during hospitalization	The duration between admission and discharge
Return-to-work status	up to 6 months after surgery
Adverse events	up to 6 months after surgery	The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
Length of hospitalization	The duration between admission and discharge

Trial Locations

Locations (1)

Taipei Medical University-Shuang Ho Hospital; 🇨🇳 Taipei, Taiwan