- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07550660
Rehabilitation Interventions for Postoperative Degenerative Lumbar Disease
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
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
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Taipei, Taiwan, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group A: Stretching and Core Training
Participants receive a combination of stretching exercises and core stability training.
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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.
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.
|
|
Experimental: Experimental Group B: Core Training
Participants receive core stability training only.
|
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.
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Active Comparator: Control Group
Participants receive standard postoperative nursing care and education without specific exercise intervention.
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Participants receive routine postoperative nursing care and standard health education provided by the neurosurgery ward.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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).
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Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
|
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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.
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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.
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Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
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Change From Baseline in 50-foot Walk Test Time
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
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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.
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Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
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Change From Baseline in Repeated Sit-to-Stand Test Time
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
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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.
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Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.
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Collaborators and Investigators
Investigators
- Study Chair: Kuei Fen Liu, RN, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202404136RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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