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The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Neuromuscular electrical stimulation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Transcranial magnetic stimulation, Neuromuscular electrical stimulation, Cortical excitability, Muscle activation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Faculty of Physical Therapy, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High frequency repetitive transcranial magnetic stimulation

Neuromuscular electrical stimulation

Arm Description

This group will receive high frequency repetitive transcranial magnetic stimulation.

This group will receive neuromuscular electrical stimulation.

Outcomes

Primary Outcome Measures

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.
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.
Motor evoked potential
The electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.
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.
Muscle thickness
Muscle contractility.
Muscle cross-sectional area
Cross-sectional area can be related to joint torque production and isokinetic strength in different muscle groups.
Muscle pennation angle
Pennation angle can represent the maximum force developed by a muscle

Secondary Outcome Measures

Force generation
Hand-held dynamometer will be used to measure muscle force.

Full Information

First Posted
July 13, 2023
Last Updated
July 23, 2023
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT05961774
Brief Title
The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits
Official Title
The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits in Adults With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2023 (Actual)
Primary Completion Date
March 14, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Transcranial magnetic stimulation, Neuromuscular electrical stimulation, Cortical excitability, Muscle activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High frequency repetitive transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
This group will receive high frequency repetitive transcranial magnetic stimulation.
Arm Title
Neuromuscular electrical stimulation
Arm Type
Active Comparator
Arm Description
This group will receive neuromuscular electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resting motor threshold
Description
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.
Time Frame
Change from baseline after 1 session
Title
Active motor threshold
Description
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.
Time Frame
Change from baseline after 1 session
Title
Motor evoked potential
Description
The electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.
Time Frame
Change from baseline after 1 session
Title
Cortical silent period
Description
The temporary interruption of electromyographic signal from a muscle following a motor evoked potential triggered by transcranial magnetic stimulation over the primary motor cortex.
Time Frame
Change from baseline after 1 session
Title
Muscle thickness
Description
Muscle contractility.
Time Frame
Change from baseline after 1 session
Title
Muscle cross-sectional area
Description
Cross-sectional area can be related to joint torque production and isokinetic strength in different muscle groups.
Time Frame
Change from baseline after 1 session
Title
Muscle pennation angle
Description
Pennation angle can represent the maximum force developed by a muscle
Time Frame
Change from baseline after 1 session
Secondary Outcome Measure Information:
Title
Force generation
Description
Hand-held dynamometer will be used to measure muscle force.
Time Frame
Change from baseline after 1 session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peemongkon Wattananon, PhD
Phone
66-2-441-5450
Ext
21803
Email
peemongkon.wat@mahidol.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peemongkon Wattananon, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Mahidol University
City
Salaya
State/Province
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peemongkon Wattananon, PhD
Phone
66-2-441-5450
Ext
21803
Email
peemongkon.wat@mahidol.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34285318
Citation
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.
Results Reference
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PubMed Identifier
33220931
Citation
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.
Results Reference
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Results Reference
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Citation
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PubMed Identifier
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Citation
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The Investigation of Underlying Mechanism of Lumbar Multifidus Muscle Activation Deficits

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