Effect Of Applied Neuromuscular Electrical Stimulation In Addition To Lumber Stabilization Exercises On The Multifidus Muscle Thickness

NCT ID: NCT05761808

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-09-01

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

Lumbar stabilization exercises constitute the first step of treatment in chronic low back pain.

Group Type: ACTIVE_COMPARATOR

exercises

Intervention Type: OTHER

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.

NMES Group

NMES will be applied in addition to lumbar stabilization exercises.

Group Type: ACTIVE_COMPARATOR

neuromuscular electrical stimulation

Intervention Type: OTHER

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.

Interventions

exercises

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

neuromuscular electrical stimulation

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

emre ata, Ass. Prof.

Role: STUDY_DIRECTOR

Sultan 2. Abdulhamid Han Training and Research Hospital

Locations

Sultan 2. Abdulhamıd Han Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

emre ata, Ass. Prof.

Role: CONTACT

emreata.ftr@gmail.com

5336152162

Facility Contacts

emre ata, ass. prof.

Role: primary

emreata.ftr@gmail.com

05336152162

Other Identifiers

2259

Identifier Type: -

Identifier Source: org_study_id