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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain; Lumbar Degenerative Disease
• Intervention / Treatment: Behavioral: Perioperative Rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiao-Ling Chen, Master; Phone Number: 8127 886-02-22490088; Email: 18395@s.tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 235
    • Recruiting
    • Taipei Medical University-Shuang Ho Hospital
    • Contact: Chiao-Ling Chen, Master; Phone Number: 8127 886-02-22490088; Email: 18395@s.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care group
Experimental: Education group	Behavioral: Perioperative Rehabilitation; Physical therapist will be consulted one day before and after the operation (OP) day. On the day before the OP day, they focus on education, including how to get up from bed and stand up from a chair. Five rehabilitation exercises are also demonstrated: 1) ankle flexion and extension, 2) knee flexion and extension, 3) hip joint abduction and adduction, 4) hip joint flexion and extension, and 5) drawing-in maneuver. The participants will be required to repeat each component to confirm that they can do it correctly. Each exercise is suggested to be done 10 times per day following MI-TLIF, and the number will be recorded 3 days (pre-OP day, post-OP day, and post-OP day 2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Oswestry Disability Index	This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.	The day before operation day, and 1, 3, 6 months after surgery
Change of Visual Analogue Scale	This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.	The day before operation day, and 1, 3, 6 months after surgery
Change of Short Form 12 version 2	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.	The day before operation day, and 1, 3, 6 months after surgery
Change of Functional reach test	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.	The day before operation day, and 1, 3, 6 months after surgery
Change of 30-second Chair Rise	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.	The day before operation day, and 1, 3, 6 months after surgery
Change of Timed Up and Go test	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.	The day before operation day, and 1, 3, 6 months after surgery
Change of 15-m walk test	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.	The day before operation day, and 1, 3, 6 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Chair: Heng-Wei Liu, Doctor, ShuangHo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 6, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; Low Back Pain; Lumbar degenerative disease
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: N201904001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No