The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits

NCT05961774 | Completed DMC

• 1 other identifier: MU-CIRB 2023/027.1503
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate mechanism underlying lumbar multifidus muscle (LM) activation deficits in adults with chronic low back pain (CLBP). The main questions it aim to answer is whether motor cortex or muscular level is the underlying mechanism responsible for the LM activation deficits. Participants will:

• Undergo cortical excitability measurement using transcranial magnetic stimulation, LM activation measurement using ultrasound imaging, and force measurement using hand-held dynamometer.
• Be randomly assigned to either repetitive magnetic stimulation (rTMS) or neuromuscular electrical stimulation (NMES)
• Undergo all measurement at post-intervention Researchers will compare within and between groups to see changes in cortical excitability, LM activation, and force.

Conditions

Low Back Pain

Keywords

Low back pain; Transcranial magnetic stimulation; Neuromuscular electrical stimulation; Cortical excitability; Muscle activation

Outcome Measures

Primary Outcomes (7)

• Resting motor threshold

  The stimulus intensity that causes a minimum motor response in a resting muscle during single transcranial magnetic stimulation (TMS) pulses applied over the motor hotspot.

  Change from baseline after 1 session

• Active motor threshold

  The lowest stimulus intensity to elicit a motor evoked potential ≥ 200μV in 5 out of 10 consecutive trials during an isometric contraction of 10% maximum voluntary contraction in the target muscle.

  Change from baseline after 1 session

• Motor evoked potential

  The electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

  Change from baseline after 1 session

• Cortical silent period

  The temporary interruption of electromyographic signal from a muscle following a motor evoked potential triggered by transcranial magnetic stimulation over the primary motor cortex.

  Change from baseline after 1 session

• Muscle thickness

  Muscle contractility.

  Change from baseline after 1 session

• Muscle cross-sectional area

  Cross-sectional area can be related to joint torque production and isokinetic strength in different muscle groups.

  Change from baseline after 1 session

• Muscle pennation angle

  Pennation angle can represent the maximum force developed by a muscle

  Change from baseline after 1 session

Secondary Outcomes (1)

• Force generation

  Change from baseline after 1 session

Study Arms (2)

High frequency repetitive transcranial magnetic stimulation

EXPERIMENTAL

This group will receive high frequency repetitive transcranial magnetic stimulation.

Device: Transcranial magnetic stimulation

Neuromuscular electrical stimulation

ACTIVE COMPARATOR

This group will receive neuromuscular electrical stimulation.

Device: Neuromuscular electrical stimulation

Interventions

Transcranial magnetic stimulation DEVICE

The stimulation point is the lumbar multifidus hotspot. The parameters will be set at frequency 10 Hz, 50 number of pulses, 40 train of stimulation (5 seconds stimulation and 25 seconds inter-stimulation interval). The position of coil will be placed tangentially at 45 degrees on the LM hotspot. The stimulation will be 20 minutes.

High frequency repetitive transcranial magnetic stimulation

Neuromuscular electrical stimulation DEVICE

The neuromuscular electrical stimulation will be set as interferential current 6000 Hz, amplitude 20-50 Hz with scanning mode, duration 20 minutes, intensity to elicit the LM contraction.

Neuromuscular electrical stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female age between 18 and 40 years.
• Experience of low back pain at least 3 months, or recurrent of back pain for at least two episodes in 6 months that interferes with activities of daily living.

You may not qualify if:

• Spondylolysis, spondylolisthesis, spine tumor and malignancy
• Radiculopathy or myelopathy
• History of lumbar or abdominal surgery
• Pregnancy
• Neurological Disease (e.g., stroke, Parkinson, traumatic brain injury, spinal cord injury)
• Major cardiovascular diseases (e.g., heart failure, coronary artery diseases, angina pain)
• Skin lesion (e.g., skin laceration) on site of stimulation.
• Experience of lumbar motor control exercise more than or equal to 2 weeks
• Metal implantation sensitive to magnetic field, or cardiac implantations
• BMI greater or equal to 30 kg/m2
• Taking any medications that would interfere with brain stimulation (e.g., Calcium channel blockers, Na+ channel blocker, NMDA antagonist, Glutamate receptor antagonist, nicotine uptake)

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (12)

• Songjaroen S, Sungnak P, Piriyaprasarth P, Wang HK, Laskin JJ, Wattananon P. Combined neuromuscular electrical stimulation with motor control exercise can improve lumbar multifidus activation in individuals with recurrent low back pain. Sci Rep. 2021 Jul 20;11(1):14815. doi: 10.1038/s41598-021-94402-2.

  PMID: 34285318 BACKGROUND

• Wattananon P, Sungnak P, Songjaroen S, Kantha P, Hsu WL, Wang HK. Using neuromuscular electrical stimulation in conjunction with ultrasound imaging technique to investigate lumbar multifidus muscle activation deficit. Musculoskelet Sci Pract. 2020 Dec;50:102215. doi: 10.1016/j.msksp.2020.102215. Epub 2020 Jul 13.

  PMID: 33220931 BACKGROUND

• Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.

  PMID: 31151377 BACKGROUND

• Wallwork TL, Stanton WR, Freke M, Hides JA. The effect of chronic low back pain on size and contraction of the lumbar multifidus muscle. Man Ther. 2009 Oct;14(5):496-500. doi: 10.1016/j.math.2008.09.006. Epub 2008 Nov 21.

  PMID: 19027343 BACKGROUND

• Tsao H, Danneels LA, Hodges PW. ISSLS prize winner: Smudging the motor brain in young adults with recurrent low back pain. Spine (Phila Pa 1976). 2011 Oct 1;36(21):1721-7. doi: 10.1097/BRS.0b013e31821c4267.

  PMID: 21508892 BACKGROUND

• Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23.

  PMID: 20655796 BACKGROUND

• Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. Corticomotor control of lumbar multifidus muscles is impaired in chronic low back pain: concurrent evidence from ultrasound imaging and double-pulse transcranial magnetic stimulation. Exp Brain Res. 2016 Apr;234(4):1033-45. doi: 10.1007/s00221-015-4528-x. Epub 2015 Dec 26.

  PMID: 26708518 BACKGROUND

• van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12.

  PMID: 29895230 BACKGROUND

• Strutton PH, Theodorou S, Catley M, McGregor AH, Davey NJ. Corticospinal excitability in patients with chronic low back pain. J Spinal Disord Tech. 2005 Oct;18(5):420-4. doi: 10.1097/01.bsd.0000169063.84628.fe.

  PMID: 16189454 BACKGROUND

• Masse-Alarie H, Beaulieu LD, Preuss R, Schneider C. The side of chronic low back pain matters: evidence from the primary motor cortex excitability and the postural adjustments of multifidi muscles. Exp Brain Res. 2017 Mar;235(3):647-659. doi: 10.1007/s00221-016-4834-y. Epub 2016 Nov 15.

  PMID: 27847987 BACKGROUND

• Patricio P, Roy JS, Macedo L, Roy M, Leonard G, Hodges P, Masse-Alarie H. Repetitive transcranial magnetic stimulation alone and in combination with motor control exercise for the treatment of individuals with chronic non-specific low back pain (ExTraStim trial): study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e045504. doi: 10.1136/bmjopen-2020-045504.

  PMID: 33762244 BACKGROUND

• O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD008208. doi: 10.1002/14651858.CD008208.pub3.

  PMID: 24729198 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Peemongkon Wattananon, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 27, 2023
• Study Start: March 15, 2023
• Primary Completion: March 14, 2024
• Study Completion: June 14, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After June 2023 for 5 years.
• Access Criteria: Written request will be reviewed by principal investigator.

Locations

TH (1)