Effect of Neuromuscular Electrical Stimulation Applied to the Lumbar Multifidus Muscle on Sit to Stand Kinematics in Individuals With Low Back Pain

Investigation on the Effect of Superimposed Neuromuscular Electrical Stimulation Technique Applied to the Lumbar Multifidus Muscle On Body Kinetics and Kinematics During Sit to Stand Activity In Individuals With Nonspecific Low Back Pain

The goal of this randomized controlled trial, is to investigate the effect of superimposed NMES and conventional NMES applied to the lumbar multifidus muscle on body kinematic and kinetic values during the sit-to-stand in individuals with non-specific low back pain. Our study will include 24 participants between the ages of 18-65. Which physiotherapy intervention will be applied to the participants will be determined by the block randomization method, using a table of random numbers. After randomization; NMES to the participants' lumbar multifidus muscle during physiotherapy intervention will be applied in two groups; In the first group, NMES will be applied with the conventional technique during prone position and in the second group, NMES will be applied with the superimposed technique during the sit-to-stand activity. Evaluations will be made twice for each participant- before and after the intervention. During the evaluation, data regarding the change in body kinetics and kinematics of individuals during the sit-to-stand activity will be recorded with a Vicon camera system. For secondary outcome measures, a visual analog scale will be used to evaluate pain, the Roland Morris Disability Questionnaire and the Oswestry Disability Index will be used to evaluate functional status, and the Tampa Kinesiophobia Scale will be used to evaluate fear-avoidance behavior.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Superimposed Neuromuscular Electrical Stimulation; Other: Conventional Neuromuscular Electrical Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Duygu Yılmaz, PT, M.Sc.; Phone Number: +905547936726; Email: duygu.dylmz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of chronic low back pain (12 weeks<)
• Pain in the lumbar and/or hip area (VAS>3)
• Volunteering to participate in the study

Exclusion Criteria:

• History of neurological, metabolic, cardiovascular disease
• Having had spinal surgery, specific lumbar pathology, scoliosis, pregnancy, history of systemic or degenerative disease
• Musculoskeletal system pathology in the last year
• Body mass index being over 30 kg/m2
• Continuing any exercise program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Superimposed Neuromuscular Electrical Stimulation Group; Superimposed NMES involves stimulating the lumbar multifidus muscle while the individual performs a sit-to-stand activity.	Other: Superimposed Neuromuscular Electrical Stimulation; The superimposed technique involves the application of electrical stimulation during voluntary muscle contraction. In our study, in the superimposed neuromuscular electrical simulation group, neuromuscular electrical stimulation will be applied to the lumbar multifidus muscle while individuals perform the activity of standing up from sitting.
Experimental: Conventional Neuromuscular Electrical Stimulation Group; Conventional NMES intervention involves only stimulating the lumbar multifidus muscle while the individual is in the prone position, and the individual will not reveal any voluntary contraction during stimulation.	Other: Conventional Neuromuscular Electrical Stimulation; The conventional neuromuscular electrical simulation technique, electrical stimulation is applied without the individual performing voluntary contractions. In our study, conventional NMES will be applied to the lumbar multifidus muscle with the individual lying in the prone position and the individual will not elicit any voluntary contractions during the simulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity	With kinematic analysis, the mean, minimum and maximum range of motion of the lumbar spine and hip joint during the sit-to-stand activity will be evaluated and recorded in degrees using the vicon motion capture system (Vicon, 6xVantage 5 Cameras 5MP@420FPS, 2xVue Video Cameras).	Baseline and first week after 8-week intervention
Changes in ground reaction force during sit-to-stand activity	Ground reaction force will be evaluated using force plates (2xAMTI force plates).	Baseline and first week after 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip and Lumbar spine range of motion	Hip and Lumbar spine range of motion will be evaluated using goniometer and recorded in degrees.	Baseline and first week after 8-week intervention
Shortness of the hip flexor, knee flexor and plantar flexor muscles	Shortness of the hip flexor, knee flexor and plantar flexor muscles will be evaluated by Thomas test, popliteal angle hamstring test and ankle dorsiflexion ROM measurements, respectively. Results will be recorded in degrees.	Baseline and first week after 8-week intervention
Beighton test	The Beighton test is a screening technique for hypermobility. The test is a nine-point scale and requires the performance of 5 maneuvers.	Baseline and first week after 8-week intervention
Visual analogue scale	Visual analog scale will be used to evaluate pain. The visual analog scale consists of a single 10 cm line used to evaluate pain intensity. Patients will be asked to mark the severity of their pain at rest, during activity and during night.	Baseline and first week after 8-week intervention
Oswestry Disability Index	Oswestry Disability Index will be used to evaluate the degree of loss of function. Higher values represent greater disability.	Baseline and first week after 8-week intervention
Roland-Morris Disability Questionnaire	Roland-Morris Disability Questionnaire will be used to evaluate functional disabilities. Higher values represent greater disability.	Baseline and first week after 8-week intervention
Tampa Kinesiophobia Scale	Tampa Kinesiophobia Scale will be used to evaluate fear of movement/reinjury. Higher values represent greater kinesiophobia.	Baseline and first week after 8-week intervention

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: December 24, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; electric stimulation; kinetic; kinematic; sit to stand
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 204574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes