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NCT Number: NCT07550660

Rehabilitation Interventions for Postoperative Degenerative Lumbar Disease

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.

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Key information

Conditions

Degenerative Lumbar Disease Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan, 100

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stretching and Core Stability Exercise Program (Group A)

Behavioral

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)

Behavioral

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 Care

Other

Participants receive routine postoperative nursing care and standard health education provided by the neurosurgery ward.

Primary outcomes

  1. 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

  1. 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).

  2. 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.

    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.

  3. Change From Baseline in 50-foot Walk Test Time

    Time frame: 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.

  4. Change From Baseline in Repeated Sit-to-Stand Test Time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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