Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

Spinal Stenosis Lumbar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538093
• Other study ID #: UCHILEKINEIT
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: April 2022
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthrosis; Spine
• Constriction, Pathologic
• Osteoarthritis
• Spinal Stenosis
• Spinal Stenosis Lumbar

Intervention

Other:
• Experimental: Local Stabilization Exercise
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
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
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.

Locations

Country	Name	City	State
Chile	University of Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks