Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
Primary Purpose
Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercises
neuromuscular electrical stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring multifidus, ultrasound
Eligibility Criteria
Inclusion Criteria: Low back pain persist more than 3 months NRS scale is above 3 Agree to participation and fill in the consent form Exclusion Criteria: radiculopathy low back pain persists less than 3 months neurological disease history of lumber spinal surgery pregnancy active skin infection obesity and morbid obesity (BMI more than 30) NMES contraindication
Sites / Locations
- Sultan 2. Abdulhamıd Han Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exercise Group
NMES Group
Arm Description
Lumbar stabilization exercises constitute the first step of treatment in chronic low back pain.
NMES will be applied in addition to lumbar stabilization exercises.
Outcomes
Primary Outcome Measures
multifudus muscle thickness
A curve probe is used for ultrasound imaging. Patients are placed prone on the examination table. A pillow is placed under the abdomen to keep the lumbosacral junction angle below 10 degrees. After visualizing the L4 spinous process in the parasagittal plane, the L4-L5 facet joint is seen by moving 2 cm laterally from the midline. Probe angulation is done to get a clearer image.
Secondary Outcome Measures
low back pain change
Numeric rating scale (NRS) is used to convert some values that cannot be measured numerically to numeric. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Full Information
NCT ID
NCT05761808
First Posted
February 27, 2023
Last Updated
June 3, 2023
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT05761808
Brief Title
Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
Official Title
In Patients With Chronic Low Back Pain, Ultrasonographic Evaluation Of The Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this clinical trial is to show the additive effects of neuromuscular electrical stimulation (NMES) applied to the multifidus muscle in addition to stabilization exercises in patients with chronic low back pain. The main question it aims to answer is:
Does NMES have additional effects on multifidus muscle thickness? Participants will go under a treatment protocol combination of lumber stabilization exercises and NMES.
Researchers will compare the groups Group 1 which has only lumber stabilization exercises and Group 2 which has both exercises and NMES to see if any changes occur in multifidus muscle thickness.
Detailed Description
Chronic low back pain is defined as low back pain lasting more than 3 months. Even if the acute pathology causing the pain is treated, chronic low back pain lasting up to 1 year can be seen in 20% of the patients. 80% of the population suffers from chronic low back pain at least once in their life. The causes of chronic low back pain can be very variable. Studies show that 70% of these pains are idiopathic and non-specific, that is, due to lumbar sprain and strain. This is followed by mechanical causes with 27%; spondylosis, spinal stenosis, lumbar disc herniation, osteoporotic fractures, congenital diseases. Apart from these, 2% referred pain; Pain due to malignancy and infection is seen in 1%.
Although the aim of the treatment of chronic low back pain varies according to the patient, the main purpose is to reduce the patient's pain and improve their functions. For this purpose, many treatment programs can be given to the patient. Exercises, physical therapy modalities, pharmacological treatments and surgical methods can be used.
Lumbar stabilization exercises are exercises for the abdominal and dorsal muscles, and many studies have previously shown their positive effects on pain and disability. However, these effects are usually short-term. Therefore, combining stabilization exercises with neuromuscular electrical stimulation (NMES) in patients with chronic low back pain and its clinical effect was questioned. Although this study could not prove the additive effect of NMES statistically, it showed important results on NMES tolerance of patients with chronic low back pain.
Multifudus muscle thickness was measured ultrasonographically in the studies. These studies show that multifidus muscle thickness is reduced in patients with chronic low back pain. Multifidus thickness measurement can be done statically and dynamically with the help of ultrasonography. In a study, static and dynamic multifudus thickness measurements were made at 3 levels (L3-L4, L4-L5, L5-S1), and high reliable results were obtained at L3-L4 and L4-L5 levels, and average reliable results were obtained at L5-S1 levels in static measurements. In dynamic measurements, reliable results were not obtained at all 3 levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
multifidus, ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Lumbar stabilization exercises constitute the first step of treatment in chronic low back pain.
Arm Title
NMES Group
Arm Type
Active Comparator
Arm Description
NMES will be applied in addition to lumbar stabilization exercises.
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
Before being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. First of all, exercises to learn transversus abdominis activation will be performed in patients. They will then be included in the stretching and strengthening exercise program. Stretching and strengthening exercises were planned as dynamic abdominal bracing, finding and maintaining neutral position, and exercises on all fours. Exercise therapy will be applied by the same physiotherapist 3 days a week for 5 weeks. Patients will continue to exercise for 7 more weeks as a home program. During this period, they will be called once a week by phone.
Intervention Type
Other
Intervention Name(s)
neuromuscular electrical stimulation
Intervention Description
NMES intensity will be planned individually according to the patients. Before being included in the study, the multifudus muscle thickness at the L4-L5 level of each patient will be measured ultrasonographically. NMES application will be applied by a specialist physiotherapist 3 days a week for 5 weeks, for a total of 15 sessions. Exercises will be applied 3 days a week for 5 weeks, accompanied by a physiotherapist. Patients will continue to exercise for 7 more weeks as a home program. In this process, patients will be called once a week by phone.
Primary Outcome Measure Information:
Title
multifudus muscle thickness
Description
A curve probe is used for ultrasound imaging. Patients are placed prone on the examination table. A pillow is placed under the abdomen to keep the lumbosacral junction angle below 10 degrees. After visualizing the L4 spinous process in the parasagittal plane, the L4-L5 facet joint is seen by moving 2 cm laterally from the midline. Probe angulation is done to get a clearer image.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
low back pain change
Description
Numeric rating scale (NRS) is used to convert some values that cannot be measured numerically to numeric. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end, and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Oswestry disability index
Description
It was developed to evaluate the degree of loss of function in low back pain. The Turkish validity and reliability of the Oswestry Disability Index (OSI), which was demonstrated in 2004, consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of change in pain, travel and social life. Under each item, there are six statements that the patient marked as appropriate for his/her condition. The first statement is scored as "0" and the sixth statement is scored as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100", the minimum score is "0". As the total score increases, the level of disability also increases.
Time Frame
3 months
Title
EQ- 5D- 3L General Quality of Life Scale
Description
It was developed to assess health-related quality of life. It consists of two parts. The first part defines the health profile in 5 dimensions: mobility, self-care, social life, pain and psychological state. Contains 3 phrases, all according to difficulty. It is evaluated as 1: little, 2: medium, 3: too much of a problem. The second part includes the analogue scale in which individuals evaluate their current health status between 0-100.
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HAD)
Description
It is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and those applying to primary health care services, and to measure the level and change in severity.
Time Frame
3 months
Title
Fear Avoidance Beliefs Questionnaire
Description
This questionnaire is a questionnaire that measures fear avoidance beliefs evaluating the effects of physical activity and work on low back pain. The questionnaire is filled by the patient. It consists of two parts. The first part is Physical Activity consisting of 5 items, and the second part is a questionnaire collected under the title of Job consisting of 11 items. Physical Activity section can get a minimum of 0 and a maximum of 24 points. The division of labor can get a minimum of 0 and a maximum of 42 points. It is accepted that there is a decrease in fear-avoidance behavior within the department as the total score approaches 0 in the evaluation, and an increase in fear-avoidance behavior as it approaches the maximum score.
Time Frame
3 months
Title
International Physical Activity Questionnaire (IPAQ)
Description
The IPAQ scale was developed in order to make physical activity inadequacy a general health problem, to require large population studies and to make comparisons between countries. In a multi-country validity and reliability study, this questionnaire was shown to be at least as good as other established measures of physical activity.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low back pain persist more than 3 months
NRS scale is above 3
Agree to participation and fill in the consent form
Exclusion Criteria:
radiculopathy
low back pain persists less than 3 months
neurological disease
history of lumber spinal surgery
pregnancy
active skin infection
obesity and morbid obesity (BMI more than 30)
NMES contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
emre ata, Ass. Prof.
Phone
5336152162
Email
emreata.ftr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emre ata, Ass. Prof.
Organizational Affiliation
Sultan 2. Abdulhamid Han Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sultan 2. Abdulhamıd Han Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emre ata, ass. prof.
Phone
05336152162
Email
emreata.ftr@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness
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