Investigation of Trunk Neuromuscular Control in Patients With Non-specific Low Back Pain
1 other identifier
interventional
16
1 country
1
Brief Summary
The purposes of this study include 1) determine clinical utility of clinical observation of aberrant movement patterns during functional trunk and pelvic movements in asymptomatic individuals and patients with non-specific low back pain, 2) characterize trunk neuromuscular control in asymptomatic individuals and patients with non-specific low back pain, and 3) determine the appropriate physical therapy intervention that addresses trunk neuromuscular control deficits in patients with non-specific low back pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started May 2015
Longer than P75 for not_applicable low-back-pain
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
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 22, 2018
March 1, 2018
2.6 years
November 17, 2016
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Electromyography (EMG) muscle activity
Muscle activity recorded by surface-electromyography (EMG) during functional movements will be used to determine muscle activation pattern changes at 8 weeks after exercise intervention.
Change from baseline muscle activity at 8 weeks after exercise intervention.
Kinematic pattern of movement
Patterns of functional movement will be captured using electromagnetic tracking system and used to determine changes in kinematic pattern of movement at 8 weeks after exercise the exercise intervention.
Change from baseline movement pattern at 8 weeks after exercise intervention.
Secondary Outcomes (3)
Numeric pain rating scale
Change in pain from baseline at 8 weeks after exercise intervention
Oswestry disability index
Change from baseline disability level at 8 weeks after exercise intervention
Short-form general heath status (SF-36) questionnaire
Change from baseline general health status at 8 weeks after exercise intervention
Study Arms (2)
Exercise intervention
EXPERIMENTALThere are 4 different exercise interventions (4 independent intervention studies) based on different concepts in this entire project. Interventions include: 1. core stabilization exercise 2. movement system impairment approach 3. neuromuscular activation using suspension 4. kinematic linkage imbalance
Healthy control
NO INTERVENTIONThis healthy control group will be informed to maintain usual daily activities and avoid participating in activities that involve trunk muscle exercise
Interventions
Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.
Eligibility Criteria
You may qualify if:
- Between the ages of 21 and 65
- Current episode of back pain less than 3 months which they seek medical intervention
- Numeric pain rating scale (NPRS) greater than 5 on an 11-point scale (0 = no pain, 10 = worst pain ever)
- Oswestry disability score (Thai version) greater than 50%
- No medical or professional health care intervention including physical therapy for low back pain in last 6 months
- Between the ages of 21 and 65
- No episode of back pain for 3 months prior to the participation
- No regular exercise routine that is composed of core stabilization exercise.
You may not qualify if:
- Clinical signs of systemic disease
- Definitive neurologic signs including weakness or numbness in the lower extremity
- Previous spinal surgery
- Diagnosed osteoporosis, severe spinal stenosis, and/or inflammatory joint disease
- Pregnancy
- Any lower extremity condition that would potentially alter trunk movement in standing
- 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
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 (3)
Biely SA, Silfies SP, Smith SS, Hicks GE. Clinical observation of standing trunk movements: what do the aberrant movement patterns tell us? J Orthop Sports Phys Ther. 2014 Apr;44(4):262-72. doi: 10.2519/jospt.2014.4988. Epub 2014 Jan 22.
PMID: 24450372BACKGROUNDHicks 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: 16181938BACKGROUNDSpinelli BA, Wattananon P, Silfies S, Talaty M, Ebaugh D. Using kinematics and a dynamical systems approach to enhance understanding of clinically observed aberrant movement patterns. Man Ther. 2015 Feb;20(1):221-6. doi: 10.1016/j.math.2014.07.012. Epub 2014 Jul 24.
PMID: 25116648BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peemongkon Wattananon, PhD
Faculty of Physical Therapy, Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 23, 2016
Study Start
May 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 22, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
Only demographic and clinical outcome data will be made available for other researchers upon request after the end of the study