Degenerative Lumbar DiseaseNCT07550660
Rehabilitation Interventions for Postoperative Degenerative Lumbar Disease
A study testing Stretching and Core Stability Exercise Program (Group A), Core Stability Exercise Program (Group B) and Standard Postoperative Nursing Care in people with Degenerative Lumbar Disease and Neuropathic Pain, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the effects of different rehabilitation interventions on patients who have undergone surgery for degenerative lumbar disease. The study focuses on assessing improvements in neuropathic pain, functional recovery, and overall quality of life. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Degenerative Lumbar Disease, Neuropathic Pain
- What is being tested?
- Stretching and Core Stability Exercise Program (Group A), Core Stability Exercise Program (Group B) and Standard Postoperative Nursing Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2024to 27 Aug 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed by a neurosurgeon with lumbar spinal stenosis, spondylolisthesis, or spondylosis involving L2-S1 segments, and scheduled for lumbar spine surgery.
- First-time recipients of lumbar spine surgery.
- Adults who are conscious and able to communicate effectively in Mandarin/Taiwanese (verbally or through writing).
- No history of psychiatric disorders.
- Willing to participate and sign the informed consent form.
Who cannot join
- Lower back pain caused by infection, inflammation, or malignancy (cancer).
- History of previous lumbar spine surgery.
- Patients with substance or drug addiction.
- Presence of psychiatric disorders.
- Unable to communicate effectively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Rehabilitation Interventions on Neuropathic Pain, Functional Recovery, and Quality of Life in Postoperative Patients With Degenerative Lumbar Disease: A Randomized Controlled Trial
The purpose of this study is to evaluate the effects of different rehabilitation interventions on patients who have undergone surgery for degenerative lumbar disease. The study focuses on assessing improvements in neuropathic pain, functional recovery, and overall quality of life. Participants will be randomly assigned to different rehabilitation programs to determine which approach provides the best outcomes for postoperative recovery.
- Conditions
- Degenerative Lumbar Disease, Neuropathic Pain
- Being tested
- Stretching and Core Stability Exercise Program (Group A), Core Stability Exercise Program (Group B), Standard Postoperative Nursing Care
- Keywords
- Rehabilitation, Postoperative Recovery, Functional Recovery, Quality of Life
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretching and Core Stability Exercise Program (Group A)Behavioural
A progressive postoperative rehabilitation program.
Day 0: Ankle pumps and pelvic tilts (4 times/day, 5 reps).
Day 1: Added heel slides, straight leg raises (SLR), and knee-to-chest stretches (4 times/day, 10 reps); walking to the bathroom (3 times/day).
Day 2: Increased reps to 15; walking outside the room (5 mins, 3 times/day).
Day 3: Increased reps to 20; increased walking time (10 mins, 3 times/day).
Day 4 to Discharge: Continued exercises and increased walking.
Post-discharge: Continued for at least 1 month.
Core Stability Exercise Program (Group B)Behavioural
Similar to Group A but without knee-to-chest stretches. Includes ankle pumps, pelvic tilts, heel slides, and SLR. The frequency and progression (reps and walking duration) are identical to Group A. Continued for at least 1 month post-discharge.
Standard Postoperative Nursing CareOther
Participants receive routine postoperative nursing care and standard health education provided by the neurosurgery ward.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A: Stretching and Core Training | Experimental | Participants receive a combination of stretching exercises and core stability training. Receives: Behavioral: Stretching and Core Stability Exercise Program (Group A); Behavioral: Core Stability Exercise Program (Group B) |
| Experimental Group B: Core Training | Experimental | Participants receive core stability training only. Receives: Behavioral: Core Stability Exercise Program (Group B) |
| Control Group | Active comparator | Participants receive standard postoperative nursing care and education without specific exercise intervention. Receives: Other: Standard Postoperative Nursing Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score
The NPSI-T evaluates 4 dimensions of neuropathic pain: spontaneous pain, paroxysmal pain, evoked pain, and dysesthesia. It consists of 18 items (including added items for cold pain, itching, and numbness). Each item is scored from 0 to 10. The total score ranges from 0 to 180, where a higher score indicates more severe neuropathic pain.
Measured: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Secondary outcomes (4)
Change From Baseline in Oswestry Disability Index (ODI) Version 2.1 Score
The ODI evaluates the impact of back pain on daily functional activities, including 10 items (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). Each item is scored 0-5. The total score is converted to a percentage (0-100%). Scoring: 0-20% (minimal disability), 21-40% (moderate), 41-60% (severe), 61-80% (crippled), and 81-100% (bed-bound).
Measured: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in 12-item Short Form Health Survey (SF-12) Score
SF-12 measures health-related quality of life across physical (PCS) and mental (MCS) components. It consists of 12 items, and scores are transformed to a 0-100 scale. Higher scores indicate better physical and mental health status.
Measured: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in 50-foot Walk Test Time
Participants are asked to walk a 25-foot distance back and forth (total 50 feet/15 meters) as fast as possible without increasing pain. The time taken to complete the task is recorded in seconds using a stopwatch. A decrease in time indicates improvement in functional mobility.
Measured: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in Repeated Sit-to-Stand Test Time
Participants perform 5 consecutive sit-to-stand repetitions from a fixed-height chair as fast as possible. The time taken is recorded in seconds. A shorter duration indicates improved lower extremity strength and balance.
Measured: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Dec 2024
- Primary completion27 Jun 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuei Fen Liu, RN, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550660
- Sponsor's protocol ID
- 202404136RINB
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Rehabilitation Interventions on Neuropathic Pain, Functional Recovery, and Quality of Life in Postoperative Patients With Degenerative Lumbar Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07550660
- Acronym / sponsor ID
- 202404136RINB
- Conditions
- Degenerative Lumbar Disease, Neuropathic Pain
- Keywords
- Rehabilitation, Postoperative Recovery, Functional Recovery, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 24 Apr 2026 (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.
The purpose of this study is to evaluate the effects of different rehabilitation interventions on patients who have undergone surgery for degenerative lumbar disease. The study focuses on assessing improvements in neuropathic pain, functional recovery, and overall quality of life. Participants will be randomly assigned to different rehabilitation programs to determine which approach provides the best outcomes for postoperative recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A: Stretching and Core Training | Experimental | Behavioral: Stretching and Core Stability Exercise Program (Group A), Behavioral: Core Stability Exercise Program (Group B)Participants receive a combination of stretching exercises and core stability training. |
| Experimental Group B: Core Training | Experimental | Behavioral: Core Stability Exercise Program (Group B)Participants receive core stability training only. |
| Control Group | Active comparator | Other: Standard Postoperative Nursing CareParticipants receive standard postoperative nursing care and education without specific exercise intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed by a neurosurgeon with lumbar spinal stenosis, spondylolisthesis, or spondylosis involving L2-S1 segments, and scheduled for lumbar spine surgery.
- First-time recipients of lumbar spine surgery.
- Adults who are conscious and able to communicate effectively in Mandarin/Taiwanese (verbally or through writing).
- No history of psychiatric disorders.
- Willing to participate and sign the informed consent form.
Key exclusion criteria (5 listed)
- Lower back pain caused by infection, inflammation, or malignancy (cancer).
- History of previous lumbar spine surgery.
- Patients with substance or drug addiction.
- Presence of psychiatric disorders.
- Unable to communicate effectively.
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 |
|---|---|---|
| Stretching and Core Stability Exercise Program (Group A)A progressive postoperative rehabilitation program. Day 0: Ankle pumps and pelvic tilts (4 times/day, 5 reps). Day 1: Added heel slides, straight leg raises (SLR), and knee-to-chest stretches (4 times/day, 10 reps); walking to the bathroom (3 times/day). Day 2: Increased reps to 15; walking outside the room (5 mins, 3 times/day). Day 3: Increased reps to 20; increased walking time (10 mins, 3 times/day). Day 4 to Discharge: Continued exercises and increased walking. Post-discharge: Continued for at least 1 month. | Behavioural | Experimental Group A: Stretching and Core Training |
| Core Stability Exercise Program (Group B)Similar to Group A but without knee-to-chest stretches. Includes ankle pumps, pelvic tilts, heel slides, and SLR. The frequency and progression (reps and walking duration) are identical to Group A. Continued for at least 1 month post-discharge. | Behavioural | Experimental Group A: Stretching and Core Training, Experimental Group B: Core Training |
| Standard Postoperative Nursing CareParticipants receive routine postoperative nursing care and standard health education provided by the neurosurgery ward. | Other | Control Group |
Primary outcome
Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
The NPSI-T evaluates 4 dimensions of neuropathic pain: spontaneous pain, paroxysmal pain, evoked pain, and dysesthesia. It consists of 18 items (including added items for cold pain, itching, and numbness). Each item is scored from 0 to 10. The total score ranges from 0 to 180, where a higher score indicates more severe neuropathic pain.
4 secondary outcomes
Change From Baseline in Oswestry Disability Index (ODI) Version 2.1 Score
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in 12-item Short Form Health Survey (SF-12) Score
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in 50-foot Walk Test Time
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Change From Baseline in Repeated Sit-to-Stand Test Time
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- 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.
Kuei Fen Liu, RN, PhD study chair
National Taiwan University 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 Stretching and Core Stability Exercise Program (Group A), Core Stability Exercise Program (Group B) and Standard Postoperative Nursing Care in people with Degenerative Lumbar Disease and Neuropathic Pain, run by National Taiwan University 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 5 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score (time frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.). 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 24 Apr 2026.