The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits

June 17, 2024 updated by: Peemongkon Wattananon, Mahidol University

The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits in Adults With Chronic Low Back Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedure The study will use a sample of convenience. The subject with CLBP will be recruited by the flyers posted at physical therapy clinic, as well as words of mouths. The participants who are interested in the study will undergo screening process for eligibility using the inclusion-exclusion criteria checklist. If the participants meet the eligibility criteria, participants will receive the brief information of the study and the consent process will be performed.

After receiving the informed consents, all participants will be requested to fill out the information sheet for demographic and clinical data. The participants will be asked to change the cloth of the top to be able to expose the lower back region. After collecting demographic and clinical data, 3-condition of LM thickness and cross-sectional area will be measured including 1) resting condition (Rest), maximum voluntary isometric contraction condition (MVIC), and maximum voluntary isometric contraction combined with neuromuscular electrical stimulation (COMB). The landmarks will be identified while the participants lay down in prone position. The landmarks include 1) lumbar spinous process of L2-L5 and 2) L4-5 facet joint (2 cm lateral to lower half of spinous process of L4). Rehabilitative ultrasound imaging (RUSI) will be used to measure LM activation and hand-held dynamometer will be used to measure force in this study across 3 conditions.

The participant will have 10 minutes rest before the transcranial magnetic stimulation (TMS). A pair of surface electrodes (Ag/AgCl, 10 mm) will be place according to SENIAM recommendation. The common ground electrode will be placed at the iliac crest. Two surface EMG electrodes will be placed relative to L4-5 along with the line joining from posterosuperior iliac spine and L1-L2 vertebral interspace (24) on the side of pain. The researcher will determine the hotspot of lumbar multifidus muscle area on the brain. The hotspot of the LM will be determined by least intensity of TMS which at least elicits 50 percent of measurable motor evoked potential (MEP) and this intensity will be the active motor threshold (AMT) of the participants. After the AMT is achieved, the 120% of AMT will be used as the intensity to induce the MEP. The MEP will be used to represent cortical excitability.

After the baseline RUSI and TMS data collection, the participants will be randomly assigned in to 2 groups include 1) NMES and high-frequency repetitive TMS (HF-rTMS) group. For HF-rTMS group, the participants will be in sitting position feet placed firmly on the floor. The stimulation point is the LM hot spot which is pre-determined by single pulse TMS as aforementioned. The HF-rTMS will be applied for participant individually. According to the theory, HF-rTMS results in facilitation of the targeted area; therefore, it will increase the excitability of the LM hot spot and potentially increase LM's neural drive and activation. 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) (34). The stimulation will approximately 20 minutes. The position of coil will be placed tangentially at 45 degrees on the LM hotspot. For the neuromuscular electrical stimulation (NMES) group, participants will be lying in prone position. The landmarks and electrodes placements are the same as mentioned in MVIC combined with NMES and LM thickness measurement. NMES parameters are interferential current 6000 Hz, amplitude 20-50 Hz with scanning mode, duration 20-minute, intensity to elicit the LM contraction (6). After the participants completed receiving the stimulation, the participant will undergo the collecting the LM thickness and force again using the same protocol.

Data will be used to 1) identify changes in cortical excitability, LM activation and force before and after stimulation at cortical level by HF-rTMS, 2) identify changes in cortical excitability, LM activation and force before and after stimulation at muscular level by NMES, and 3) compare the percent changes in cortical excitability, LM activation and force between stimulation at cortical (by HF-rTMS) and muscular (by NMES) levels.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Nakhon Pathom
      • Salaya, Nakhon Pathom, Thailand, 73170
        • Faculty of Physical Therapy, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High frequency repetitive transcranial magnetic stimulation
This group will receive high frequency repetitive transcranial magnetic stimulation.
Device: Transcranial magnetic stimulation
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.
Active Comparator: Neuromuscular electrical stimulation
This group will receive neuromuscular electrical stimulation.
Device: Neuromuscular electrical stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting motor threshold
Time Frame: Change from baseline after 1 session
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
Time Frame: Change from baseline after 1 session
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
Time Frame: Change from baseline after 1 session
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
Time Frame: Change from baseline after 1 session
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
Time Frame: Change from baseline after 1 session
Muscle contractility.
Change from baseline after 1 session
Muscle cross-sectional area
Time Frame: Change from baseline after 1 session
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
Time Frame: Change from baseline after 1 session
Pennation angle can represent the maximum force developed by a muscle
Change from baseline after 1 session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Force generation
Time Frame: Change from baseline after 1 session
Hand-held dynamometer will be used to measure muscle force.
Change from baseline after 1 session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

National Research Council of Thailand

Investigators

  • Principal Investigator: Peemongkon Wattananon, PhD, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Actual)

March 14, 2024

Study Completion (Actual)

June 14, 2024

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU-CIRB 2023/027.1503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unidentifiable data can be shared upon request.

IPD Sharing Time Frame

After June 2023 for 5 years.

IPD Sharing Access Criteria

Written request will be reviewed by principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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