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Clinical Trials/NCT03349580
NCT03349580
Completed
N/A

Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength

Dejan Kernc0 sites27 target enrollmentApril 4, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lumbar Spine Fusion
Sponsor
Dejan Kernc
Enrollment
27
Primary Endpoint
Change of isometric trunk muscle strength
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

To analyze safety and the effects of early initiation of the rehabilitation. Including the objective measurement outcomes after lumbar spine fusion, based on the principles of strength training.

Detailed Description

The 27 patients were recruited for the study, aged 45 to 70 years, who had undergone lumbar spine fusion. The patients were randomized in to two groups. The strength training group started rehabilitation 3 weeks after surgery. The patients exercised two times per week, over 9 weeks. The focus was on muscle activation of lumbopelvic muscles stabilization. The control group followed a standard postoperative protocol, where no exercises were performed at the rehabilitation stage. The functional outcomes and the plain radiographs were evaluated after 3 weeks and subsequently after 3 and 18 months after the surgery.

Registry
clinicaltrials.gov
Start Date
April 4, 2014
End Date
September 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dejan Kernc
Responsible Party
Sponsor Investigator
Principal Investigator

Dejan Kernc

Principal Investigator

University Medical Centre Ljubljana

Eligibility Criteria

Inclusion Criteria

  • Primary diagnosis of degenerative, low-grade isthmic spondylolisthesis or degenerative disc disease with or without spinal stenosis.

Exclusion Criteria

  • Previous lumbar fusion surgery, degenerative or idiopathic scoliosis, inflammatory disease, and history of malignancy.

Outcomes

Primary Outcomes

Change of isometric trunk muscle strength

Time Frame: Baseline, 9 weeks and 18 months.

The isometric trunk muscle extension, flexion and lateral flexion strength were measured using a strain-gauge dynamometer. Maximum torque was calculated from the force sensor data (Newton) and the lever as a distance between the middle line of the belt and the iliac crest level (meter). A higher values represent a better outcome. The scale range were 48 Nm -830 Nm for extension, 12 Nm - 1010 Nm for flexion, 35 Nm - 680 Nm for lateral flexion right and 16 Nm - 640 Nm for lateral flexion left.

Change of low back pain disability as measured by the Oswestry Disability Index

Time Frame: Baseline, 9 weeks and 18 months.

Self-reported levels of low back pain disability. The Oswestry Disability Index is presented as a score from 0 to 100 where lower scores represent lower levels of low back pain disability.

Secondary Outcomes

  • Change of walking distance as measured by the 6-min walking test(Baseline, 9 weeks and 18 months.)
  • Change the repetition of stand-ups during the Chair stand test.(Baseline, 9 weeks and 18 months.)
  • Change of height as measured by the Standing reach height test.(Baseline, 9 weeks and 18 months.)
  • Change of Intra-abdominal pressure pre-activation pattern.(Baseline, 9 weeks and 18 months.)
  • Change of pain disability as measured by the Visual Analogue Scale.(Baseline, 9 weeks and 18 months.)

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