Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
7 oktober 2019 uppdaterad av: Taipei Medical University Shuang Ho Hospital
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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Taipei, Taiwan, 235
- Rekrytering
- Taipei Medical University-Shuang Ho Hospital
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Kontakt:
- Chiao-Ling Chen, Master
- Telefonnummer: 8127 886-02-22490088
- E-post: 18395@s.tmu.edu.tw
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
45 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Vanlig vårdgrupp
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Experimentell: Utbildningsgrupp
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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).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change of Oswestry Disability Index
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's physical function.
The range is 0 to 1. Higher values represent a better outcome.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Visual Analogue Scale
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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This scale evaluates subject's pain intensity.
"0" indicates no pain and "10" indicates the worst possible pain.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Short Form 12 version 2
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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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.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Functional reach test
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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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.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 30-second Chair Rise
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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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.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of Timed Up and Go test
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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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.
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The day before operation day, and 1, 3, 6 months after surgery
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Change of 15-m walk test
Tidsram: The day before operation day, and 1, 3, 6 months after surgery
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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.
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The day before operation day, and 1, 3, 6 months after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Length of hospitalization
Tidsram: The duration between admission and discharge
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The duration between admission and discharge
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Narcotic use during hospitalization
Tidsram: The duration between admission and discharge
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The duration between admission and discharge
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Return-to-work status
Tidsram: up to 6 months after surgery
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up to 6 months after surgery
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Adverse events
Tidsram: up to 6 months after surgery
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The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
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up to 6 months after surgery
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Heng-Wei Liu, Doctor, Shuangho Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 april 2019
Primärt slutförande (Förväntat)
1 oktober 2021
Avslutad studie (Förväntat)
1 januari 2022
Studieregistreringsdatum
Först inskickad
6 oktober 2019
Först inskickad som uppfyllde QC-kriterierna
7 oktober 2019
Första postat (Faktisk)
9 oktober 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 oktober 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 oktober 2019
Senast verifierad
1 oktober 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N201904001
Plan för individuella deltagardata (IPD)
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NEJ
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