The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study

NCT02435485 | Unknown DMC

• 1 other identifier: CMRPG8D0911
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with degenerative lumbar spondylolisthesis usually are present with low back pain, muscle spasm and weakness, radicular symptoms, intermittent claudication, insomnia, even urine or stool incontinence. There are very few research on the effectiveness of core spine stabilization exercise, balance training, and the balance effect while wearing lumbar corset in these patients. Purpose: To investigate 1) the correlation of dynamic balance and the degree of disability with the characteristics of spinopelvic alignment. 2) potential predictors of dynamic spino-pelvic instability, 3) the effectiveness of core spine stabilization exercise, balance training and balance effect of the wearing of lumbar corset in patients with degenerative lumbar spondylolisthesis .

Conditions

Spinal Instability

Keywords

degerative lumbar spondylolisthesis; rehabilitation; balance

Outcome Measures

Primary Outcomes (1)

• Biodex balance test

  1. Postural stability test: overall index\_\_\_, anterior-posterior index\_\_\_, medial-lateral index\_\_\_\_ 2. Limits of stability test: forward\_\_\_, backward\_\_\_, right\_\_\_, left\_\_\_, forward/right\_\_\_, forward/left\_\_\_, backward/right\_\_\_, backward/left\_\_\_ 3. Modified clinical test of sensory integration: sway index: eye open, firm\_\_\_; eye close,firm\_\_\_, eye open, foam\_\_\_, eye close foam\_\_\_ 4. Fall risk test: actual score, STD\_\_\_\_\_\_\_

  8 weeks, 6 months

Secondary Outcomes (3)

• Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire)

  8 week, 6 months

• Quebec back pain disability scale

  8 weeks, 6 months

• Visual analog scale (VAS) of low back pain and radicular pain

  8 weeks, 6 months

Study Arms (3)

spondylolisthesis with balance training

EXPERIMENTAL

Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise.

Device: Biodex balance training; Other: Rehabilitation including core spinal stabilization exercise

spondylolisthesis, no balance training

ACTIVE COMPARATOR

Intervention: Regular rehabilitation including core spinal stabilization exercise

Other: Rehabilitation including core spinal stabilization exercise

lumbar spondylitis

ACTIVE COMPARATOR

Intervention: Regular rehabilitation including core spinal stabilization exercise

Other: Rehabilitation including core spinal stabilization exercise

Interventions

Biodex balance training DEVICE

1.weight shift training, 2. random control training with Biodex balance system.

spondylolisthesis with balance training

Rehabilitation including core spinal stabilization exercise OTHER

Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.

lumbar spondylitis; spondylolisthesis with balance training; spondylolisthesis, no balance training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, low back pain, or radicular symptoms and diagnosed by KUB and lateral radiography of the lumbar-sacral spine in neutral, flexion-extension, will be recruited. Among them, seventy patients with degenerative lumbar spondylolisthesis as the experimental group and thirty-five patients with lumbar spondylitis will be included as the control group.

You may not qualify if:

• Patient older than 80 years of age, with stroke, spinal cord injury, head injury or other neurological deficits, previous operation of vertebrae fracture, pelvis or lower limb, isthmic lumbar spondylolisthesis, or cognitive impairment. -

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

Kaohsiung City, 83305, Taiwan

RECRUITING

Study Officials

• Mei-Yun Liaw, MD

  Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Yun Liaw, MD

CONTACT

886-7-7317123; meiyunliaw@cgmh.org.tw

Ling-Yi Wang, MD

CONTACT

886-7-7317123; s801121@cloud.cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of physical medicine and rehabilitation

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 6, 2015
• Study Start: October 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: May 22, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)