Clinical trial NCT03538093: 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
Overall status: COMPLETED
Phase: NA
Conditions: Arthrosis; Spine
Spinal Stenosis Lumbar
Keywords: arthrodesis
core stabilization
physical therapy
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain
timeFrame: 12 weeks
measure: Disability
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: University of Chile
Study officials:
affiliation: Instituto Traumatológico Dr. Teodoro Gebauer Weisser
name: Mario Lecaros, MSc
role: PRINCIPAL_INVESTIGATOR
References: