Clinical trial NCT05761808: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: multifidus
ultrasound
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: multifudus muscle thickness
timeFrame: 3 months
Secondary outcomes:
measure: low back pain change
timeFrame: 3 months
Other outcomes:
measure: Oswestry disability index
timeFrame: 3 months
measure: EQ- 5D- 3L General Quality of Life Scale
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: 3 months
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: 3 months
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 3 months
Locations:
city: Istanbul
country: Turkey
facility: Sultan 2. Abdulhamıd Han Training and Research Hospital
Study officials:
affiliation: Sultan 2. Abdulhamid Han Training and Research Hospital
name: emre ata, Ass. Prof.
role: STUDY_DIRECTOR
References: