Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercises in Chronic Low Back Pain Patients

NCT ID: NCT03862898

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2018-03-30

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lumbar stabilization exercises

Intervention Type: OTHER

Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.

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.

Group Type: ACTIVE_COMPARATOR

Lumbar stabilization exercises

Intervention Type: OTHER

Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.

Interventions

Lumbar stabilization exercises

Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stefan Kostadinović

OTHER

Sponsor Role: lead

Responsible Party

Stefan Kostadinović

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ljubica Konstantinovic, Phd

Role: STUDY_CHAIR

Clinic for rehabilitation "dr Miroslav Zotović", Belgrade

Locations

Clinic for rehabilitation "dr Miroslav Zotović"

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

01-39/122/1

Identifier Type: -

Identifier Source: org_study_id