Rehabilitation Interventions for Postoperative Degenerative Lumbar Disease

NCT07550660 | Completed

• 1 other identifier: 202404136RINB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Degenerative Lumbar Disease

Keywords

Rehabilitation; Postoperative Recovery; Functional Recovery; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (3)

Experimental Group A: Stretching and Core Training

EXPERIMENTAL

Participants receive a combination of stretching exercises and core stability training.

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.

Behavioral: Core Stability Exercise Program (Group B)

Control Group

ACTIVE COMPARATOR

Participants receive standard postoperative nursing care and education without specific exercise intervention.

Other: Standard Postoperative Nursing Care

Interventions

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.

Experimental Group A: Stretching and Core Training

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.

Experimental Group A: Stretching and Core Training; Experimental Group B: Core Training

Standard Postoperative Nursing Care OTHER

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

Control Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kuei Fen Liu, RN, PhD

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 24, 2026
• Study Start: December 1, 2024
• Primary Completion: June 27, 2025
• Study Completion: August 27, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)