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Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

Primary Purpose

Arthrosis; Spine, Spinal Stenosis Lumbar

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Experimental: Local Stabilization Exercise
Experimental: Global Stabilization Exercise
Experimental: Mixed Stabilization Exercise
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthrosis; Spine focused on measuring arthrodesis, core stabilization, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chile

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Local Stabilization Exercise

Global Stabilization Exercise

Mixed Stabilization Exercise

Arm Description

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).

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).

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.

Outcomes

Primary Outcome Measures

Pain
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.
Disability
Measured by Oswestry Disability Index, which ranges from 0 to 100. 0 is equated with no disability and 100 is the maximum disability possible.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2018
Last Updated
April 23, 2022
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03538093
Brief Title
Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine which type of lumbar stabilization exercise is more effective to improve functionality and reduce pain in patients operated with lumbar arthrodesis, to guide clinical practice in the rehabilitation of these patients.
Detailed Description
The objective of this study is to determine which exercise modality (global, local or mixed) is most effective in reducing pain and improving function at 6 and 12 weeks after the operation. The methodology will be a randomized experimental clinical trial. The study population will be subjects who underwent surgery for lumbar spinal stenosis due to decompression and posterolateral fusion. The estimation of the sample size was made on the basis of the ANOVA test measures, following the guidelines established by Stevens, for which an α = 0.05 and β = 0.2 were used, power = 80% and moderate effect size. As a result, the program (GPower) gave us a total sample size of 24 subjects, so we will use a sample of 30 subjects due to the possibility of departure of some of them abandoning during the process. The sample will be taken from a waiting list of lumbar spinal stenosis surgery at the Traumatological Institute of Santiago (IT). To measure the level of functionality, we will use the Oswestry Disability Index 2.0 in Spanish, and for pain, the Visual Analogue Scale, in addition to recording general data. For each instrument, 3 measurements will be taken: preoperative, 6 and 12 weeks after the operation. To analyze the data, the program of the latest version of IBM SPSS Statistics Base will be used, a Shapiro Wilks normality test will be performed to confirm a normal distribution and then an ANOVA of repeated measures to confirm the hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthrosis; Spine, Spinal Stenosis Lumbar
Keywords
arthrodesis, core stabilization, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local Stabilization Exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Global Stabilization Exercise
Arm Type
Experimental
Arm Description
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).
Arm Title
Mixed Stabilization Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Local Stabilization Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Global Stabilization Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: Mixed Stabilization Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
12 weeks
Title
Disability
Description
Measured by Oswestry Disability Index, which ranges from 0 to 100. 0 is equated with no disability and 100 is the maximum disability possible.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Lecaros, MSc
Organizational Affiliation
Instituto Traumatológico Dr. Teodoro Gebauer Weisser
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chile
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

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