search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Lumbar stabilization exercises
Sponsored by
Stefan Kostadinović
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinic for rehabilitation "dr Miroslav Zotović"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lumbar stabilization group- thoracic

lumbar stabilization group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Dolour Neuropathic test (DN4)
It is a questionnaire for assessing the neuropathic component of pain. Consists of four questions. Answers to the first two are obtained on the basis of an interview with the patient and they speak of the character of the pain, and the other two, based on a clinical examination. In the first, three responses are offered, in the second four, the third two, and in the last question, one answer. The respondent does not have to give an answer, and can respond to more than one offered. If the patient's score is 4 or greater, the test indicates that there is a specificity greater than 90% for the test subjects in determining the neuropathic pain component
Prone instability test
This test is performed by exposing the spinosus process of the lumbar spine to the hypothenar, while the patient is in the stomach position at the edge of the table, with toes on the floor. When the subject reports pain, the examiner instructs him to lift his fingers from the floor and lift his legs to a horizontal position. If the patient now has no discomfort or pain, the test is positive.

Full Information

First Posted
March 2, 2019
Last Updated
March 5, 2019
Sponsor
Stefan Kostadinović
search

1. Study Identification

Unique Protocol Identification Number
NCT03862898
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 29, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stefan Kostadinović

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lumbar stabilization group- thoracic
Arm Type
Experimental
Arm Description
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.
Arm Title
lumbar stabilization group
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Lumbar stabilization exercises
Intervention Description
Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
eight weeks
Title
Functional disability
Description
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.
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Dolour Neuropathic test (DN4)
Description
It is a questionnaire for assessing the neuropathic component of pain. Consists of four questions. Answers to the first two are obtained on the basis of an interview with the patient and they speak of the character of the pain, and the other two, based on a clinical examination. In the first, three responses are offered, in the second four, the third two, and in the last question, one answer. The respondent does not have to give an answer, and can respond to more than one offered. If the patient's score is 4 or greater, the test indicates that there is a specificity greater than 90% for the test subjects in determining the neuropathic pain component
Time Frame
eight weeks
Title
Prone instability test
Description
This test is performed by exposing the spinosus process of the lumbar spine to the hypothenar, while the patient is in the stomach position at the edge of the table, with toes on the floor. When the subject reports pain, the examiner instructs him to lift his fingers from the floor and lift his legs to a horizontal position. If the patient now has no discomfort or pain, the test is positive.
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ljubica Konstantinovic, Phd
Organizational Affiliation
Clinic for rehabilitation "dr Miroslav Zotović", Belgrade
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic for rehabilitation "dr Miroslav Zotović"
City
Belgrade,
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs