NCT02200913

Brief Summary

Recent studies indicate that patients with chronic low back pain (LBP) present problems in balance. Alterations in proprioception are the possible causes of alteration of postural balance in LBP. Previous studies reported an improvement of CSE on joint mobility, pain, functional disability, and trunk muscle activation pattern in patients with clinical lumbar instability (CLI); however, it was an immediate effect. However, previous studies did not report indirect effect may occur in CLI as postural balance and other kinds of exercise as strengthening in CLI. The general trunk strengthening exercise is common used in physical therapy clinic on LBP, that improve pain, physical disability, and trunk muscles activity. To our knowledge, the usefulness of CSE has not yet been investigated in CLI patients with outcome measure of balance. The present study will conduct to fill the gaps of previous studies which will provide immediate-, accumulative- and detraining-effects of CSE on postural balance, pain intensity and ratio activation of trunk muscles and included blinding process of the assessor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

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

July 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4.8 years

First QC Date

July 24, 2014

Last Update Submit

January 22, 2020

Conditions

Lumbar Spine Instability

Outcome Measures

Primary Outcomes (1)

  • center of pressure

    up to 3-months after the last intervention session

Study Arms (2)

core stabilization exercise

EXPERIMENTAL

core stabilization exercise 2 times/week 10 weeks

Other: general trunk strengthening exercise

general trunk strengthening exercise

EXPERIMENTAL

general trunk strengthening exercise, 2 times/week, 10 weeks

Other: core stabilization exercise

Interventions

core stabilization exerciseOTHER

core stabilization exercise, 2 times/week, 10 weeks

general trunk strengthening exercise
general trunk strengthening exerciseOTHER

general trunk strengthening exercise, 2 times/week, 10 weeks

core stabilization exercise

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male or female
  • aged between 20-60 years
  • low back pain (LBP) with or without radiating leg pain for period of at least 12 weeks
  • answer 'yes' at least seven items of questionnaire
  • present positive sign of the aberrant movement sign
  • Present at least one positive sign from painful catch , prone instability catch test, or apprehension symptom

You may not qualify if:

  • Be pregnant.
  • Have serious spinal pathology: spinal fracture, spinal malignancy or spinal infection
  • Have quada equina syndrome
  • Have neurological deficit (at least 2 of the following signs: weakness of lower limbs (muscle power \< grade 3 using manual muscle test), reflex changes, or abnormality or loss of sensation of lower limbs associated with the spinal nerve root
  • Have obvious abnormal movement of the lumbar motion segment when assessed by flexion-extension radiographs: sagittal plane translation larger than 4.5mm or 15 percent of vertebral body width according to other vertebral segment, or sagittal plane rotation larger than 15 degrees at L1-L2, L2-L3 or L3-L4, 20 degrees at L4-L5 or 25 degrees at L5-S1
  • Have visual disorder, vestibular disorder, neuromuscular diseases such as polyneuropathy, or diabetes neuropathy
  • Participate in their intervention less than 5 out of the 10 week of intervention.
  • Regularly treat with core stabilization exercise (CSE), or trunk strengthen exercises.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center in Back, Neck, Other Joint Pain and Human Performance

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

  • Puntumetakul R, Areeudomwong P, Emasithi A, Yamauchi J. Effect of 10-week core stabilization exercise training and detraining on pain-related outcomes in patients with clinical lumbar instability. Patient Prefer Adherence. 2013 Nov 19;7:1189-99. doi: 10.2147/PPA.S50436. eCollection 2013.

    PMID: 24399870RESULT

Study Officials

  • Wantanee Yodchaisarn, M.Sc.

    Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Center in Back, Neck, Other Joint Pain and Human Performance

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 25, 2014

Study Start

August 1, 2014

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

TH(1)