Clinical trial NCT03862898: Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercises in Chronic Low Back Pain Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of Novi Sad
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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,
* tumors,
* pregnancy.

Primary outcomes:
measure: Pain intensity
timeFrame: eight weeks
measure: Functional disability
timeFrame: eight weeks
Secondary outcomes:
measure: Dolour Neuropathic test (DN4)
timeFrame: eight weeks
measure: Prone instability test
timeFrame: eight weeks
Other outcomes:
Locations:
city: Belgrade,
country: Serbia
facility: Clinic for rehabilitation "dr Miroslav Zotović"
Study officials:
affiliation: Clinic for rehabilitation "dr Miroslav Zotović", Belgrade
name: Ljubica Konstantinovic, Phd
role: STUDY_CHAIR
References: