Clinical trial NCT04120532: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lumbar Degenerative Disease
Keywords: rehabilitation
Lumbar degenerative disease
Low Back Pain
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of Oswestry Disability Index
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of Visual Analogue Scale
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of Short Form 12 version 2
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of Functional reach test
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of 30-second Chair Rise
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of Timed Up and Go test
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
measure: Change of 15-m walk test
timeFrame: The day before operation day, and 1, 3, 6 months after surgery
Secondary outcomes:
measure: Length of hospitalization
timeFrame: The duration between admission and discharge
measure: Narcotic use during hospitalization
timeFrame: The duration between admission and discharge
measure: Return-to-work status
timeFrame: up to 6 months after surgery
measure: Adverse events
timeFrame: up to 6 months after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
Study officials:
affiliation: ShuangHo Hospital
name: Heng-Wei Liu, Doctor
role: STUDY_CHAIR
References: