Corticospinal Excitability of Deep Back and Abdominal Muscles
1 other identifier
interventional
24
1 country
1
Brief Summary
This study aims to understand the roles of corticospinal excitability in controlling the trunk movement, and the clinical utility of clinical observation, as well as the effect of lumbopelvic stabilization during hamstrings muscle stretching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2020
CompletedFebruary 20, 2020
February 1, 2020
1.1 years
November 13, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Resting and active motor threshold
Resting and active motor threshold (MT) for ipsilateral and contralateral responses for transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Motor evoke potentials
Motor evoke potentials (MEP) for transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Center of gravity of Topography
Center of gravity coordinate of Topography of transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Volume of Topography
Volume of Topography of transverse abdominis and lumbar multifidus muscles.
These data will be collected at baseline only.
Clinical observation of aberrant movement.
Clinical observation of aberrant movement patterns during functional movement will be performed by two physical therapists.
These data will be collected at baseline only.
Motion data.
Clinical motion analysis system will be used to measure lumbar, pelvic, lumbopelvic, and knee motions. This system is composed of triple axis accelerometers (MPU6050, China), data acquisition board (Arduino Uno R3, Italy), and a LabVIEW software version 2012 (National Instrument, USA). The system will be used to measure pre- and post-intervention of angle of lumbar, pelvic, and lumbopelvic motions through a custom LabVIEW program at 100 Hz.
These data will be measure at baseline and immediately after receiving stretching exercise technique.
Secondary Outcomes (4)
Passive straight leg raising to test clinical lumbar instability
These data will be collected at baseline only.
Muscle length based on modified Thomas and Trendelenburg test
These data will be collected at baseline only.
Abdominal and back muscle strength .
These data will be collected at baseline only.
1-year follow-up.
1 year after data collection.
Study Arms (2)
Lumbopelvic stiffening technique
EXPERIMENTALHamstring muscle stretching with lumbopelvic stiffening technique.
Lumbopelvic relaxing technique
ACTIVE COMPARATORHamstrings muscle stretching with lumbopelvic relaxing technique.
Interventions
Participants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands "during adjusting the bed up, please tense the back rigid". After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands "During adjusting the bed up, please relax the back". The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions.
Eligibility Criteria
You may qualify if:
- Between the ages of 20 and 40
- No history of LBP that interferes with activities of daily living and/or required treatment
- Between the ages of 20 and 40
- A recurrent pattern of LBP at least two episodes that interfered with activities of daily living and/or required treatment
- Presenting aberrant movement pattern during active forward bend test
- Passive straight leg raising test (SLR) greater than 91 degrees
- Having hamstrings muscle tightness of both legs (passive knee extension in supine with 90° hip flexion position greater than 20 degrees)
You may not qualify if:
- History of seizure for either the subject or any family member
- Implanted pacemaker
- Clinical signs of systemic disease
- Definitive neurologic signs including pain, weakness or numbness in the lower extremity
- Previous spinal surgery
- Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
- Any lower extremity condition that would potentially alter trunk movement
- Vestibular dysfunction
- Extreme psychosocial involvement
- Body mass index (BMI) greater than 30 kg/m2
- Active treatment of another medical illness that would preclude participation in any aspect of the study
- Menstruation or pregnancy (for female subject)
- Diagnosed herniated nucleus pulposus (HNP)
- Pain medication usage (e.g., NSAID)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170, Thailand
Related Publications (5)
Tsao H, Galea MP, Hodges PW. Reorganization of the motor cortex is associated with postural control deficits in recurrent low back pain. Brain. 2008 Aug;131(Pt 8):2161-71. doi: 10.1093/brain/awn154. Epub 2008 Jul 18.
PMID: 18669505BACKGROUNDTsao H, Tucker KJ, Hodges PW. Changes in excitability of corticomotor inputs to the trunk muscles during experimentally-induced acute low back pain. Neuroscience. 2011 May 5;181:127-33. doi: 10.1016/j.neuroscience.2011.02.033. Epub 2011 Feb 17.
PMID: 21333720BACKGROUNDHicks GE, Fritz JM, Delitto A, McGill SM. Preliminary development of a clinical prediction rule for determining which patients with low back pain will respond to a stabilization exercise program. Arch Phys Med Rehabil. 2005 Sep;86(9):1753-62. doi: 10.1016/j.apmr.2005.03.033.
PMID: 16181938BACKGROUNDSahrmann S, Azevedo DC, Dillen LV. Diagnosis and treatment of movement system impairment syndromes. Braz J Phys Ther. 2017 Nov-Dec;21(6):391-399. doi: 10.1016/j.bjpt.2017.08.001. Epub 2017 Sep 27.
PMID: 29097026BACKGROUNDJandre Reis FJ, Macedo AR. Influence of Hamstring Tightness in Pelvic, Lumbar and Trunk Range of Motion in Low Back Pain and Asymptomatic Volunteers during Forward Bending. Asian Spine J. 2015 Aug;9(4):535-40. doi: 10.4184/asj.2015.9.4.535. Epub 2015 Jul 28.
PMID: 26240711BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Peemongkon Wattananon, PhD
Faculty of Physical Therapy, Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The assessor and investigator will be blinded to the random order. This process will be handled by the research manager.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 13, 2018
First Posted
November 20, 2018
Study Start
December 14, 2018
Primary Completion
January 6, 2020
Study Completion
January 6, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The supporting information will be sent upon official request.
- Access Criteria
- Having an official written request.
The IPD of this study will be shared upon official request.