NCT02972073

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

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable low-back-pain

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

Study Start

First participant enrolled

May 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

November 17, 2016

Last Update Submit

March 21, 2018

Conditions

Keywords

Low back painNeuromuscular control

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

EXPERIMENTAL

There 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

Other: Exercise intervention

Healthy control

NO INTERVENTION

This 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.

Exercise intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 24450372BACKGROUND
  • 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
  • Spinelli 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

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peemongkon Wattananon, PhD

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

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

Locations