NCT03747185

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

November 13, 2018

Last Update Submit

February 18, 2020

Conditions

Keywords

Clinical lumbar instabilityHistory of low back painCorticospinal excitabilityStretching exerciseMovement system impairment

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

EXPERIMENTAL

Hamstring muscle stretching with lumbopelvic stiffening technique.

Other: Lumbopelvic stiffening techniqueOther: Lumbopelvic relaxing technique

Lumbopelvic relaxing technique

ACTIVE COMPARATOR

Hamstrings muscle stretching with lumbopelvic relaxing technique.

Other: Lumbopelvic stiffening techniqueOther: 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.

Lumbopelvic relaxing techniqueLumbopelvic stiffening technique

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.

Lumbopelvic relaxing techniqueLumbopelvic stiffening technique

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 18669505BACKGROUND
  • Tsao 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: 21333720BACKGROUND
  • Hicks 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: 16181938BACKGROUND
  • Sahrmann 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: 29097026BACKGROUND
  • Jandre 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

  • Peemongkon Wattananon, PhD

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

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
Model Details: Participants will be randomly assigned to either stretching exercise with lumbopelvic stiffening technique or lumbopelvic relaxing technique. They will be provided a 2-day wash-out period. Then, participants will cross-over to another technique.
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

The IPD of this study will be shared upon official request.

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.

Locations