- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538093
Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery
Clinical and Functional Differences Between Local, Global and Mixed Lumbar Stabilization Exercises in Rehabilitation of Adult Patients With Lumbar Arthrodesis Surgery Due to Spinal Stenosis: a Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Santiago, Chile
- University of Chile
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged over 18 years old, operated of lumbar spine arthrodesis for degenerative spinal stenosis at Traumatological Institute of Santiago de Chile
Exclusion Criteria:
- Overweight
- Underweight
- Previous Surgeries
- Postoperative complications
- Higher pain in lower limbs than in low back
- Inability to exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Local Stabilization Exercise
Experimental: Local Stabilization Exercise Consists of a standard inpatient and outpatient rehabilitation program which includes exercises that focuses the activation of the muscles considered as local stabilizers of the core (Transversus Abdominis and Multifidus).
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Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: manual transversus a. activation exercises, multifidus cross activation exercise, sitting on the edge of the bed. Day 3: bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions. Outpatient phase:4th-6th week: hot compress + electrotherapy IFT (fr: 4kHz, AMF 100Hz, modulation 20Hz, 20 mins), stabilizer training. Hamstring, quadriceps, gluteus maximus and psoas stretching, stationary bicycle without load. 7th-9th week: stabilizer training elevating a leg, stationary bicycle low load. 10th-12th week: 1kg to elevated leg on stabilizer training, stationary bicycle moderate load. |
Experimental: Global Stabilization Exercise
Experimental: Global Stabilization Exercise Consists of a standard inpatient and outpatient rehabilitation program which includes exercises that focuses the activation of the muscles considered as global stabilizers of the core (Erector Spinae, Quadratus Lumborum, Abdominal External Oblique, Abdominal Internal Oblique and Rectus Abdominis).
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Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: add obliques cross exercises in supine with contralateral leg, lumbopelvic bridge exercises, sitting on the edge of the bed. Day 3: add bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions. Outpatient phase: physiotherapy: 4th-6th week: hot compress + electrotherapy IFT, lumbopelvic bridge exercises, obliques cross exercises. Hamstring, quadriceps, gluteus maximus and medius stretching, stationary bicycle without load. 7th-9th week: FST, global exercises, stationary bicycle low load. 10th-12th week: physiotherapy, side plank, unilateral bridge, stationary bicycle moderate load. |
Experimental: Mixed Stabilization Exercise
Experimental: Mixed Stabilization Exercise Consists of a standard inpatient and outpatient rehabilitation program which includes exercises that focuses the activation of both local and global core stabilizer muscles.
|
Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: manual transversus abdominis activation exercises, multifidus cross activation exercise, sitting on the edge of the bed. Day 3: bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions. 4th-6th week: hot compress + electrotherapy IFT, stabilizer training, hamstring, quadriceps, gluteus maximus and medius stretching, stationary bicycle without load. 7th-9th week: FST, global exercises, change stationary bicycle load to low load. 10th-12th week: physiotherapy, advanced global exercise (side plank), unilateral bridge,stationary bicycle moderate load. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 12 weeks
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Visual Analog Scale of pain.
The range of the scale goes from 0 (no pain) to 10 (unbearable pain), and from a color spectrum between blue (0) and red (10).
The result is measured as the distance (in milimeters), from 0 to the point the patient indicates.
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12 weeks
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Disability
Time Frame: 12 weeks
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Measured by Oswestry Disability Index, which ranges from 0 to 100.
0 is equated with no disability and 100 is the maximum disability possible.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mario Lecaros, MSc, Instituto Traumatologico Dr. Teodoro Gebauer Weisser
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCHILEKINEIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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