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Clinical Trials/NCT05761808
NCT05761808
Recruiting
N/A

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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey1 site in 1 country40 target enrollmentMarch 1, 2023
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Enrollment
40
Locations
1
Primary Endpoint
multifudus muscle thickness
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
September 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

multifudus muscle thickness

Time Frame: 3 months

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 Outcomes

  • low back pain change(3 months)

Study Sites (1)

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