Degenerative Lumbar Disease, Neuropathic Pain
Conditions
Keywords
Rehabilitation, Postoperative Recovery, Functional Recovery, Quality of Life
Brief 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. Participants will be randomly assigned to different rehabilitation programs to determine which approach provides the best outcomes for postoperative recovery.
Interventions
BEHAVIORALStretching 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.
BEHAVIORALCore 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.
OTHERStandard Postoperative Nursing Care
Participants receive routine postoperative nursing care and standard health education provided by the neurosurgery ward.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants were informed that they would be assigned to one of different postoperative rehabilitation programs but were not told the specific differences between the exercise protocols.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oswestry Disability Index (ODI) Version 2.1 Score | 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). |
| Change From Baseline in 12-item Short Form Health Survey (SF-12) Score | Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery. | 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. |
| Change From Baseline in 50-foot Walk Test Time | Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery. | 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. |
| Change From Baseline in Repeated Sit-to-Stand Test Time | Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery. | 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. |
Countries
Taiwan
Contacts
STUDY_CHAIRKuei Fen Liu, RN, PhD
National Taiwan University Hospital
Outcome results
None listed