Early Initiation of a Strength Training Based Rehabilitation After Lumbar Spine Fusion Improves Core Muscle Strength
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Primary Endpoint
- Change of low back pain disability as measured by the Oswestry Disability Index
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
The training group
The training group performed rehabilitation program twice per week over 9 weeks. The group commenced rehabilitation 3 weeks after the surgery. During the phase one training (week 1 to week 5), the isometric exercises were preformed on the trunk extension, flexion and lateral flexion muscles. During the phase 2 (week 6 to week 9), the exercises were performed on the strength machines and duration of the exercises were maintained and prolonged to 30 seconds. The leg adduction and hip extension exercises were added. The patients were instructed to perform abdominal bracing (IAP) and maintain the neutral position of their lumbar spine before and during the exercises.
Intervention: The training group (Behavioral)
The control group
The control group followed the hospital's standard protocol. These do not include exercises or physiotherapy before 3 months after surgery.
Outcomes
Primary Outcomes
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.
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.
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.)
Investigators
Dejan Kernc
Principal Investigator
University Medical Centre Ljubljana