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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Taiwan Version of Neuropathic Pain Symptom Inventory (NPSI-T) Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
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 Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Experimental Group A: Stretching and Core Training
Participants receive a combination of stretching exercises and core stability training.
Intervention: Stretching and Core Stability Exercise Program (Group A) (Behavioral)
Experimental Group A: Stretching and Core Training
Participants receive a combination of stretching exercises and core stability training.
Intervention: Core Stability Exercise Program (Group B) (Behavioral)
Experimental Group B: Core Training
Participants receive core stability training only.
Intervention: Core Stability Exercise Program (Group B) (Behavioral)
Control Group
Participants receive standard postoperative nursing care and education without specific exercise intervention.
Intervention: Standard Postoperative Nursing Care (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in Oswestry Disability Index (ODI) Version 2.1 Score(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(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)
- Change From Baseline in 50-foot Walk Test Time(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)
- Change From Baseline in Repeated Sit-to-Stand Test Time(Baseline, 1 week, 2 weeks, 4 weeks, and 8 weeks post-surgery.)