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

NCT03862898 | Completed

• 1 other identifier: 01-39/122/1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  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

  eight weeks

• Functional disability

  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.

  eight weeks

Secondary Outcomes (2)

• Dolour Neuropathic test (DN4)

  eight weeks

• Prone instability test

  eight weeks

Study Arms (2)

lumbar stabilization group- thoracic

EXPERIMENTAL

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.

Other: Lumbar stabilization exercises

lumbar stabilization group

ACTIVE COMPARATOR

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.

Other: Lumbar stabilization exercises

Interventions

Lumbar stabilization exercises 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 group- thoracic

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with lumbar pain present for more than 12 weeks,
• pain during changing of the position,
• radicular pain.

You may not qualify if:

• Cauda equina syndrome,
• ankylosing spondylitis,
• thoracic deformities (pectus carinatum, excavatum),
• spina bifida,
• fractures,
• post-operative spinal conditions,
• diabetes,
• inflammatory processes,
• tumors,
• pregnancy.

Sponsors & Collaborators

• Stefan Kostadinović: lead

Study Sites (1)

Clinic for rehabilitation "dr Miroslav Zotović"

Belgrade, 11000, Serbia

Location

Study Officials

• Ljubica Konstantinovic, Phd

  Clinic for rehabilitation "dr Miroslav Zotović", Belgrade

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 5, 2019
• Study Start: June 29, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

SE (1)