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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862898
• Other study ID #: 01-39/122/1
• Status: Completed
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2019
• Source: University of Novi Sad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Serbia	Clinic for rehabilitation "dr Miroslav Zotovic"	Belgrade,

Sponsors (1)

Lead Sponsor	Collaborator
Stefan Kostadinovic

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	eight weeks
Secondary	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.	eight weeks