NCT02895828

Brief Summary

This study will compare the effects of 2 exercise programs including core stabilization exercise and general trunk strengthening exercise programs on trunk muscle activity, physical dysfunction, quality of life and lumbar motion in low back pain patient with clinical lumbar instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration 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

November 24, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

November 24, 2014

Last Update Submit

January 22, 2020

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Effect of 2-exercise on quality of life

    health-related quality of life was measured by using SF-36 questionnaire

    Change from baseline at 10-week after training session, and follow up session

Secondary Outcomes (4)

  • Effect of 2-exercise on physical disability

    Change from baseline at 10-week after training session, and follow up session

  • Effect of 2-exercise on trunk muscle activity

    Change from baseline at 10-week after training session, and follow up session

  • Effect of 2-exercise on lumbar segmental motion

    Change from baseline at 10-week after training session, and follow up session

  • Effect of 2-exercise on pain intensity

    Change from baseline at 10-week after training session, and follow up session

Study Arms (2)

Core Stabilization Exercise (CSE)

EXPERIMENTAL

The participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks

Other: Core Stabilization Exercise

General Strengthening Exercise (GSE)

EXPERIMENTAL

The participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks.

Other: General Strengthening Exercise

Interventions

Core Stabilization ExerciseOTHER

the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks

Core Stabilization Exercise (CSE)
General Strengthening ExerciseOTHER

the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks

General Strengthening Exercise (GSE)

Eligibility Criteria

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

You may qualify if:

  • Chronic low back pain due to clinical lumbar instability

You may not qualify if:

  • Specific low back pain
  • Cuada equine syndrome
  • Neurological deficit

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, 40000, Thailand

Location

Related Publications (2)

  • 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: 24399870BACKGROUND

  • Javadian Y, Behtash H, Akbari M, Taghipour-Darzi M, Zekavat H. The effects of stabilizing exercises on pain and disability of patients with lumbar segmental instability. J Back Musculoskelet Rehabil. 2012;25(3):149-55. doi: 10.3233/BMR-2012-0321.

    PMID: 22935853BACKGROUND

Study Officials

  • Wantanee Yodchaisarn, M.Sc.

    The Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Khon Kaen University, Thailand

    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
Principal investigator

Study Record Dates

First Submitted

November 24, 2014

First Posted

September 12, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

TH(1)