Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercise Program on Pain Intensity and Functional Disability Reduction in Chronic Low Back Pain Patients: a Randomized Controlled Single-blind Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Functional disability
Study Overview
Brief Summary
Chronic low-back pain (CLBP) is a heterogeneous group of disorders, which according to the new classification of the International Association for Pain Research (IASP), is recognized as an independent entity and belongs to a mixed type of pain caused by central sensitization , which is present for more than 12 weeks. Studies have found that lumbar segmental instability (LSI) is one of the most significant cause of lumbar pain through the movement of each spinal segment where degenerative changes were observed in the discs. The aim of this study was to compare the program of lumbar stabilization exercises in the open and closed kinetic chain, in relation to the program of lumbar stabilization exercises and thoracic mobilization in a closed kinetic chain, to evaluate the clinical efficacy of both exercise programs and determine whether initial pain intensity values and disability levels affect the outcome of patients with chronic low back pain. The study was conducted as randomized, single-blind, controlled trial in 80 chronic low-back pain (CLBP) patients of both sexes (35 male, 45 female), average age (48.45 +/- 10.22 years, treated at the Rehabilitation Clinic "Dr. Miroslav Zotović" in Belgrade between June 2017 and March 2018. Respondents were divided into two groups of 40 patients by simple randomization. Participants were given laser therapy, transcutaneous electrical nerve stimulation (TENS) and an eight-week kinesiotherapy that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done after 4 and 8 weeks. Patients who performed lumbar stabilization and thoracic mobilization exercises program in a closed kinetic chain had better functional recovery and a significant reduction in pain intensity compared to respondents who performed a lumbar stabilization program in opened and closed kinetic chain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with lumbar pain present for more than 12 weeks,
- •pain during changing of the position,
- •radicular pain.
Exclusion Criteria
- •Cauda equina syndrome,
- •ankylosing spondylitis,
- •thoracic deformities (pectus carinatum, excavatum),
- •spina bifida,
- •fractures,
- •post-operative spinal conditions,
- •diabetes,
- •inflammatory processes,
- •pregnancy.
Arms & Interventions
lumbar stabilization group- thoracic
Lumbar stabilization and thoracic mobilization in a closed kinetic chain (LSTMC) group performed this exercises from the least to the largest painless motion amplitude and accordingly divided into three phases. The first phase lasted for two weeks, the second three and the last third phase, also for three weeks, and a total of 8 weeks.
Intervention: Lumbar stabilization exercises (Other)
lumbar stabilization group
Lumbar stabilization in a closed and opened kinetic chain (LSCO) group also performed exercises from the least to the largest painless motion amplitude in three phases.
Intervention: Lumbar stabilization exercises (Other)
Outcomes
Primary Outcomes
Functional disability
Time Frame: eight weeks
According to Oswestry disability Index, functional disability was assessed. This index contains ten categories of six questions. The intensity of pain, the ability to raise loads, take care of oneself, walk, sit, sexual functions, standing, social life, the quality of sleep and traveling. The patient completes the label in front of him, which most resembles his situation. Each category is scored on a scale of 0-5, where the first statement is zero and indicates the smallest amount of incapacity, and the last statement of 5 points shows a very difficult degree of disability.
Pain intensity
Time Frame: eight weeks
According to Visual Analogue scale, pain intensity was assessed for lumbosacral spine and for the leg in mm. On the graphic scale, there is a horizontal line of 10 cm. The beginning of the line with 0 is marked, which indicates that there is no pain, the middle with 5 and the end with 10, which marks the strongest pain. The respondents are asked to mark the site, which most closely indicates the intensity of his pain in the back in the past 24 hours, and then on the scale mark the severity of pain in the back and legs. After that, the ruler measures the obtained value in the millimeters and they are entered
Secondary Outcomes
- Prone instability test(eight weeks)
- Dolour Neuropathic test (DN4)(eight weeks)
Investigators
Stefan Kostadinović
Principal Investigator
University of Novi Sad