Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04120532
Other study ID # N201904001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2019
Est. completion date January 2022

Study information

Verified date October 2019
Source Taipei Medical University Shuang Ho Hospital
Contact Chiao-Ling Chen, Master
Phone 886-02-22490088
Email 18395@s.tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2022
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 45 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Taiwan Taipei Medical University-Shuang Ho Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Length of hospitalization The duration between admission and discharge
Secondary Narcotic use during hospitalization The duration between admission and discharge
Secondary Return-to-work status up to 6 months after surgery
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03916705 - Thoraco-Lumbar Fascia Mobility N/A
Completed NCT04007302 - Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Recruiting NCT03600207 - The Effect of Diaphragm Muscle Training on Chronic Low Back Pain N/A
Completed NCT04284982 - Periodized Resistance Training for Persistent Non-specific Low Back Pain N/A
Recruiting NCT05600543 - Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain N/A
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Completed NCT03673436 - Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Completed NCT02546466 - Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain N/A
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05156242 - Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain. N/A
Recruiting NCT04673773 - MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain. N/A
Completed NCT06049277 - Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain N/A
Completed NCT06049251 - ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises N/A
Completed NCT04980469 - A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle N/A
Completed NCT04055545 - High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects N/A
Recruiting NCT05944354 - Wearable Spine Health System for Military Readiness
Recruiting NCT05552248 - Assessment of the Safety and Performance of a Lumbar Belt
Completed NCT05801588 - Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life N/A
Completed NCT05811143 - Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.