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Completed

NCT Number: NCT06212011

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

The goal of this randomized controlled trial, is to investigate the effect of functional 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 functional 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Neuromuscular Electrical Stimulation

Other

The functional NMES technique involves the application of electrical stimulation during functional activity. In our study, in the functional 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.

Conventional Neuromuscular Electrical Stimulation

Other

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.

Primary outcomes

  1. Changes in kinematics of the Lumbar Spine and Hip During sit-to-stand activity

    Time frame: Baseline and first week after 8-week intervention

    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).

  2. Changes in ground reaction force during sit-to-stand activity

    Time frame: Baseline and first week after 8-week intervention

    Ground reaction force will be evaluated using force plates (2xAMTI force plates).

Secondary outcomes

  1. Hip and Lumbar spine range of motion

    Time frame: Baseline and first week after 8-week intervention

    Hip and Lumbar spine range of motion will be evaluated using goniometer and recorded in degrees.

  2. Shortness of the hip flexor, knee flexor and plantar flexor muscles

    Time frame: Baseline and first week after 8-week intervention

    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.

  3. Beighton test

    Time frame: Baseline and first week after 8-week intervention

    The Beighton test is a screening technique for hypermobility. The test is a nine-point scale and requires the performance of 5 maneuvers.

  4. Visual analogue scale

    Time frame: Baseline and first week after 8-week intervention

    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.

  5. Oswestry Disability Index

    Time frame: Baseline and first week after 8-week intervention

    Oswestry Disability Index will be used to evaluate the degree of loss of function. Higher values represent greater disability.

  6. Roland-Morris Disability Questionnaire

    Time frame: Baseline and first week after 8-week intervention

    Roland-Morris Disability Questionnaire will be used to evaluate functional disabilities. Higher values represent greater disability.

  7. Tampa Kinesiophobia Scale

    Time frame: Baseline and first week after 8-week intervention

    Tampa Kinesiophobia Scale will be used to evaluate fear of movement/reinjury. Higher values represent greater kinesiophobia.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation on the Effect of Functional 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2024
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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