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

Primary Purpose

Low Back Pain, Lumbar Degenerative Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Perioperative Rehabilitation
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring rehabilitation, Lumbar degenerative disease, Low Back Pain

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Medical University-Shuang Ho HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education group

Usual care group

Arm Description

Outcomes

Primary Outcome Measures

Change of Oswestry Disability Index
This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Change of Visual Analogue Scale
This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Length of hospitalization
Narcotic use during hospitalization
Return-to-work status
Adverse events
The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).

Full Information

First Posted
October 6, 2019
Last Updated
October 7, 2019
Sponsor
Taipei Medical University Shuang Ho Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04120532
Brief Title
Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
Official Title
Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbar Degenerative Disease
Keywords
rehabilitation, Lumbar degenerative disease, Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education group
Arm Type
Experimental
Arm Title
Usual care group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Perioperative Rehabilitation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of Oswestry Disability Index
Description
This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of Visual Analogue Scale
Description
This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of Short Form 12 version 2
Description
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.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of Functional reach test
Description
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.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of 30-second Chair Rise
Description
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.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of Timed Up and Go test
Description
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.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Title
Change of 15-m walk test
Description
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.
Time Frame
The day before operation day, and 1, 3, 6 months after surgery
Secondary Outcome Measure Information:
Title
Length of hospitalization
Time Frame
The duration between admission and discharge
Title
Narcotic use during hospitalization
Time Frame
The duration between admission and discharge
Title
Return-to-work status
Time Frame
up to 6 months after surgery
Title
Adverse events
Description
The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
Time Frame
up to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiao-Ling Chen, Master
Phone
886-02-22490088
Ext
8127
Email
18395@s.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heng-Wei Liu, Doctor
Organizational Affiliation
ShuangHo Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University-Shuang Ho Hospital
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiao-Ling Chen, Master
Phone
886-02-22490088
Ext
8127
Email
18395@s.tmu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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