Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery

University of Chile

Status: Completed

Conditions: Spinal Stenosis Lumbar; Arthrosis; Spine

Treatments: Other: Experimental: Local Stabilization Exercise; Other: Experimental: Global Stabilization Exercise; Other: Experimental: Mixed Stabilization Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03538093

UCHILEKINEIT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

Local Stabilization Exercise

Experimental group

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).

Treatment:

Other: Experimental: Local Stabilization Exercise

Global Stabilization Exercise

Experimental group

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).

Treatment:

Other: Experimental: Global Stabilization Exercise

Mixed Stabilization Exercise

Experimental group

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.

Treatment:

Other: Experimental: Mixed Stabilization Exercise