Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

Not Applicable

Completed

• Conditions: Spinal Stenosis Lumbar; Arthrosis; Spine

• Registration Number: NCT03538093
• Lead Sponsor: University of Chile

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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-25
• Study Start: 2018-06-21
• Primary Completion: 2019-05-01
• Study Completion: 2019-07-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-23
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disability	12 weeks	Measured by Oswestry Disability Index, which ranges from 0 to 100. 0 is equated with no disability and 100 is the maximum disability possible.
Pain	12 weeks	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.

Trial Locations

Locations (1)

University of Chile; 🇨🇱 Santiago, Chile