Low Back PainNCT04120532
Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
A study testing Perioperative Rehabilitation in people with Low Back Pain and Lumbar Degenerative Disease, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Low Back Pain, Lumbar Degenerative Disease
- What is being tested?
- Perioperative Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Apr 2019to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Emergency surgery.
- Unstable vital sign.
- Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
- Had spinal surgery before.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University-Shuang Ho Hospital
Taipei, 235
Chiao-Ling Chen, Master, 886-02-22490088 ext. 8127, 18395@s.tmu.edu.tw
About this study
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.
- Conditions
- Low Back Pain, Lumbar Degenerative Disease
- Being tested
- Perioperative Rehabilitation
- Keywords
- rehabilitation, Lumbar degenerative disease, Low Back Pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative RehabilitationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Education group | Experimental | Not described Receives: Behavioral: Perioperative Rehabilitation |
| Usual care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Oswestry Disability Index
This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The day before operation day, and 1, 3, 6 months after surgery
Secondary outcomes (4)
Length of hospitalization
Measured: The duration between admission and discharge
Narcotic use during hospitalization
Measured: The duration between admission and discharge
Return-to-work status
Measured: up to 6 months after surgery
Adverse events
The rate of infection and the rate of re-operation (including: dural tear, cage migration and retropulsion, and screw loosening).
Measured: up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start25 Apr 2019
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heng-Wei Liu, Doctor, Study chair, ShuangHo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120532
- Sponsor's protocol ID
- N201904001
- Status last verified
- Oct 2019
- First submitted
- 6 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health Education for Patients Received Minimally Invasive Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT04120532
- Acronym / sponsor ID
- N201904001
- Conditions
- Low Back Pain, Lumbar Degenerative Disease
- Keywords
- rehabilitation, Lumbar degenerative disease, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education group | Experimental | Behavioral: Perioperative Rehabilitation |
| Usual care group | No intervention | – |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Emergency surgery.
- Unstable vital sign.
- Any psychological, neurological, orthopedics, cardiopulmonary, and cancer history.
- Had spinal surgery before.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative RehabilitationPhysical 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). | Behavioural | Education group |
Primary outcome
Change of Oswestry Disability Index
Time frame: The day before operation day, and 1, 3, 6 months after surgery
This scale evaluates subject's physical function. The range is 0 to 1. Higher values represent a better outcome.
Change of Visual Analogue Scale
Time frame: The day before operation day, and 1, 3, 6 months after surgery
This scale evaluates subject's pain intensity. "0" indicates no pain and "10" indicates the worst possible pain.
Change of Short Form 12 version 2
Time frame: The day before operation day, and 1, 3, 6 months after surgery
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.
Change of Functional reach test
Time frame: The day before operation day, and 1, 3, 6 months after surgery
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.
Change of 30-second Chair Rise
Time frame: The day before operation day, and 1, 3, 6 months after surgery
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.
Change of Timed Up and Go test
Time frame: The day before operation day, and 1, 3, 6 months after surgery
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.
Change of 15-m walk test
Time frame: The day before operation day, and 1, 3, 6 months after surgery
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.
4 secondary outcomes
Length of hospitalization
Time frame: The duration between admission and discharge
Narcotic use during hospitalization
Time frame: The duration between admission and discharge
Return-to-work status
Time frame: up to 6 months after surgery
Adverse events
Time frame: up to 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heng-Wei Liu, Doctor study chair
ShuangHo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Rehabilitation in people with Low Back Pain and Lumbar Degenerative Disease, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiao-Ling Chen, Master (886-02-22490088 ext. 8127, 18395@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Oswestry Disability Index (time frame: The day before operation day, and 1, 3, 6 months after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.