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

NCT05761808 | Unknown

• 1 other identifier: 2259
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

multifidus; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• low back pain change

  3 months

Other Outcomes (5)

• Oswestry disability index

  3 months

• EQ- 5D- 3L General Quality of Life Scale

  3 months

• Hospital Anxiety and Depression Scale (HAD)

  3 months

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR

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

Other: exercises

NMES Group

ACTIVE COMPARATOR

NMES will be applied in addition to lumbar stabilization exercises.

Other: neuromuscular electrical stimulation

Interventions

exercises 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.

Exercise Group

neuromuscular electrical stimulation 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.

NMES Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Low back pain persist more than 3 months
• NRS scale is above 3
• Agree to participation and fill in the consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamıd Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• emre ata, Ass. Prof.

  Sultan 2. Abdulhamid Han Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

emre ata, Ass. Prof.

CONTACT

5336152162; emreata.ftr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)