NCT04120532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

October 6, 2019

Last Update Submit

October 7, 2019

Conditions

Low Back PainLumbar Degenerative Disease

Keywords

rehabilitationLumbar degenerative diseaseLow Back Pain

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (4)

  • 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

    up to 6 months after surgery

Study Arms (2)

Education group

EXPERIMENTAL
Behavioral: Perioperative Rehabilitation

Usual care group

NO INTERVENTION

Interventions

Perioperative RehabilitationBEHAVIORAL

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).

Education group

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University-Shuang Ho Hospital

Taipei, 235, Taiwan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heng-Wei Liu, Doctor

    ShuangHo Hospital

    STUDY CHAIR

Central Study Contacts

Chiao-Ling Chen, Master

CONTACT

886-02-2249008818395@s.tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 9, 2019

Study Start

April 25, 2019

Primary Completion

October 1, 2021

Study Completion

January 1, 2022

Last Updated

October 9, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)