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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02435485
Recruitment Status : Unknown
Verified May 2018 by Mei-Yun Liaw, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Yun Liaw, Chang Gung Memorial Hospital

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date May 22, 2018
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Biodex balance test [ Time Frame: 8 weeks, 6 months ]
  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_______
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
Biodex balance test [ Time Frame: 8 weeks ]
  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_______
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2018)
  • Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire) [ Time Frame: 8 week, 6 months ]
    To measure a patient's permanent functional disability
  • Quebec back pain disability scale [ Time Frame: 8 weeks, 6 months ]
    This questionnaire is about the way patient's back pain affecting their daily life
  • Visual analog scale (VAS) of low back pain and radicular pain [ Time Frame: 8 weeks, 6 months ]
    Visual analog scale [VAS] is a measure of pain intensity
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
  • Oswestry Disability Index (Oswestry Low Back Pain Disability Questionnaire) [ Time Frame: 8 week ]
  • Quebec back pain disability scale [ Time Frame: 8 weeks ]
  • Visual analog scale (VAS) of low back pain and radicular pain [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
Official Title  ICMJE The Rehabilitation Outcome of Patients With Lumbar Spondylolisthesis. A Prospective Randomized Study
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 .

Detailed Description

Subjects :Seventy patients with lumbar spondylolisthesis will be randomly assigned to the group treated with balance training and without balance training, and another thirty-five age-matched lumbar spondylitis without spondylolisthesis will be assigned as control group.

Method: Patients older than 50 years of age with lumbar spondylitis or degenerative lumbar spondylolisthesis, 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 will be recruited as experimental group and thirty-five patients with lumbar spondylitis will be recruited as control group. Exclusion criteria are 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.

All subjects will receive Visual Analogue Scale (VAS), Oswestry Disability Index, Quebec back pain disability scale, and the postural stability test, 75% limits of stability test, modified clinical test of sensory integration, and the evaluation of fall risk test of Biodex balance system at beginning and at the end of program. Both the control and experimental groups will receive rehabilitation training, including hot packing, interferential therapy, core spine stabilization exercise and lower extremity strengthening exercise for 2-3 times a week, up to 8 weeks, 15 sessions in total. Patients in the experimental group will be randomly assigned to either a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program. The investigators will follow up with these patients by telephone 3 months after program completion.

The clinical history, age, gender, body weight, body height, job, symptoms and sign, Visual Analogue Scalce (VAS), Questionnairem (Quebec back pain disability scale) and Oswestry Disability Index will be recorded at base and after rehabilitation program. Every subject will sign the informed consent, which will be obtained from the Institutional Review Board of Chang Gung Memorial Hospital.

Physical examination It will include the duration, pain intensity, neurologic deficits, muscle power of lower limbs, deep tendon reflex, sensation, stretch sign or nerve conduction velocity, or electromyography examination.

Radiography All subjects will receive Kidney Ureter Bladder (KUB) and standing lateral radiography of lumbar-sacral spine in neutral, to determine the pelvic incidence, pelvic tilt, sacral slope etc. Furthermore the patients with spondylolisthesis will receive flexion-extension of lumbar-sacral spine to determine the degree of translational motion of vertebrae.

Rehabilitation Correct body posture and lifting techniques will be instructed. After patient's back pain subside to a degree of less than 5 of visual analogue scale (VAS), balance test will be assessed by using the Biodex Balance System (BBS), including postual stability test, limits of stability test, modified clinical test of sensory intergration and fall risk test. The spondylolisthesis patients will be assessed while wearing or without wearing lumbar corset at the beginning of the program, which will be tested in a random order. The tester for BBS will be blind to the patient's grouping. The anterio-posterior, medial-lateral stability index and overall stability index etc will be recorded.

Both groups will receive 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include 15-minute hot packing, 15-minutes interferential therapy, about 25 minutes of core spine stablilzation exercise and low extremity strengthening exercise on the stationary bicycle. And patients in the experimental group will be randomly assigned either to a balance training group or to a group without balance training. The balance training will include both weight shift training and random control training with Biodex balance system. A balance effect of wearing lumbar corset will be evaluated at the beginning of the program.

Balance test

  1. Postual stability test: Patients will stand barefoot on the platform with a slight knee flexion, look straight ahead with arms across the chest on the platform, and then subject will be asked to maintain a quiet stance on the platform for seconds for initialization. Six stability trials will be performed with eyes open and eyes closed over a period of 20 seconds, 3 trials per each state, with 10-second count rest countdown in between the trials.
  2. Limits of stabitiy (LOS) test (75% LOS): an indicator of dynamic control within a normalized envelope. Nine targets blink in random order on the screen. Patient have to shift body weight to move the cursor frorm the center target to a blinking target and back as quickly and with as little deviation as possible. The overall direction control of overall, forward, backward, right, left, forward/right, forward/right, backward/right and backward/left will be recorded.
  3. Modified clinical test of sensory intergration: It consists of the first condition: eye open with firm surface, the second condition: eye closed with firm surface, the third condition: eye open with foam surface and the fourth condition: eye closed with foam surface
  4. Fall risk test: to identify the high potential fall risk patient.

Rehabilitation program (Home base or outpatient training) Education: Both of home base and outpatient training patients will be instructed to use superficial heat for relief of back pain, muscle spasm; and correct posture of the activities of daily living (sitting, standing, sleeping, working and driving), lifting techniques, avoidance of certain movements and postures, such as prolonged standing or sitting, slouched in a soft armchair, sagging bed mattresses, wearing high heels or carrying heavy objects. And lumbar corset for stabilization of spine will be recommended.

Outpatient program: Two to three times a week, 15 treatment sessions, about 60 minutes per session, up to 8 weeks. It will include hot pack and/or interferential therapy about 15 minutes. Exercise (about 25 min) will begin with a short warm-up aerobic exercise, upper back and shoulder extension exercise, pectoral stretching exercise, back extension exercise, combined with deep-breathing exercise; then a core strengthening program, including cat and camel, abdominal hollowing, bridge, dead bug, quadruped etc. The exercise will be 3 sessions of 10-15 repetitions.

Balance training Balance training: same as rehabilitation program (total 15 sessions, 2-3 times a weeks)

  1. Weight shifting training Guiding moving point (a) from quarter one to quarter three, (b) from quarter two to quarter four, (c) in parallel to the vertical line in the feedback screen (anterior-posterior direction)
  2. Random training It is ideal for motor control and vestibular training. Static mode : work within the sway envelope to move the cursor and attempt to keep it within the moving target.

Dynamic mode: use hip, knee and ankle strategies to manipulate the moving palteform's cursor to within the random moving target.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Spinal Instability
Intervention  ICMJE
  • Device: Biodex balance training
    1.weight shift training, 2. random control training with Biodex balance system.
  • Other: Rehabilitation including core spinal stabilization exercise
    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.
Study Arms  ICMJE
  • Experimental: spondylolisthesis with balance training
    Intervention: 1. Biodex balance training including weight shift training and random control training, 2. Regular rehabilitation including core spinal stabilization exercise.
    Interventions:
    • Device: Biodex balance training
    • Other: Rehabilitation including core spinal stabilization exercise
  • Active Comparator: spondylolisthesis, no balance training
    Intervention: Regular rehabilitation including core spinal stabilization exercise
    Intervention: Other: Rehabilitation including core spinal stabilization exercise
  • Active Comparator: lumbar spondylitis
    Intervention: Regular rehabilitation including core spinal stabilization exercise
    Intervention: Other: Rehabilitation including core spinal stabilization exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02435485
Other Study ID Numbers  ICMJE CMRPG8D0911
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mei-Yun Liaw, Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mei-Yun Liaw, MD Department of Physical Medicine and Rehabilitation, Kaohsiung Chang Gung Memorial Hospital.
PRS Account Chang Gung Memorial Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP