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

NCT ID: NCT04120532

Last Updated: 2019-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2022-01-31

Brief Summary

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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

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Conditions

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Low Back Pain Lumbar Degenerative Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Education group

Group Type EXPERIMENTAL

Perioperative Rehabilitation

Intervention Type BEHAVIORAL

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).

Usual care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heng-Wei Liu, Doctor

Role: STUDY_CHAIR

ShuangHo Hospital

Locations

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Taipei Medical University-Shuang Ho Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chiao-Ling Chen, Master

Role: CONTACT

886-02-22490088 ext. 8127

Facility Contacts

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Chiao-Ling Chen, Master

Role: primary

886-02-22490088 ext. 8127

Other Identifiers

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N201904001

Identifier Type: -

Identifier Source: org_study_id

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