Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain (CSENSLBP)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Core stabilization exercise
Conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Onset of back pain within 6 -12 weeks participants had no history of back pain for a period of 6 months prior to the current episode.
- Pain intensity measure by a numerical rating scale (0-10 NRS) and a score of pain at least 3 out of 10.
- Never receive the treatment by core stabilization exercise (CSE) during 3 months before participate in this study.
Exclusion Criteria:
- Pregnancy
- Onset of serious spinal pathology: spinal fracture, spinal tumor or spinal infection.
- Cauda equina syndrome.
- Presented at least 2 out of 3 signs of neurological deficit
Sites / Locations
- Faculty of Associated Medical Sciences, Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Core stabilization exercise
conventional treatment
Arm Description
7-weeks of core stabilization exercise
7-weeks of conventional treatment include therapeutic ultrasound and hot pack
Outcomes
Primary Outcome Measures
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
Secondary Outcome Measures
Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7
This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score
Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7
Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)
Change From Baseline in Repositioning Error on Repositioning Test at Week 7
This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)
Full Information
NCT ID
NCT02645760
First Posted
December 31, 2015
Last Updated
August 10, 2016
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT02645760
Brief Title
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain
Acronym
CSENSLBP
Official Title
Comparison of Core Stabilization Exercise and Physical Therapy Treatment in Patients With Subacute Non-specific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to examines the effectiveness of Core stabilization exercise on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain.
Detailed Description
This study is to compare the effectiveness of Core stabilization exercise and physical therapy on pain intensity at rest, functional disability, lumbar movement and ability to perform repositioning tasks (joint position sense) in patients with subacute non-specific low back pain. There are 2 groups receiving 2 different kinds of intervention: treatment group receiving core stabilization exercise (CSE) and control group receiving physical therapy including therapeutic ultrasound and hydrocollator pack. Each intervention will perform for 7 weeks. The patients will assess for all outcome measures at baseline, 7 weeks of intervention, and 1- month follow-up
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core stabilization exercise
Arm Type
Active Comparator
Arm Description
7-weeks of core stabilization exercise
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
7-weeks of conventional treatment include therapeutic ultrasound and hot pack
Intervention Type
Other
Intervention Name(s)
Core stabilization exercise
Intervention Description
7-weeks of core stabilization exercise
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
7-weeks of conventional treatment include therapeutic ultrasound and hot pack
Primary Outcome Measure Information:
Title
Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7
Description
The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)
Time Frame
baseline an week 7
Secondary Outcome Measure Information:
Title
Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7
Description
This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score
Time Frame
baseline and week 7
Title
Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7
Description
Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)
Time Frame
baseline and week 7
Title
Change From Baseline in Repositioning Error on Repositioning Test at Week 7
Description
This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)
Time Frame
baseline and week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Onset of back pain within 6 -12 weeks participants had no history of back pain for a period of 6 months prior to the current episode.
Pain intensity measure by a numerical rating scale (0-10 NRS) and a score of pain at least 3 out of 10.
Never receive the treatment by core stabilization exercise (CSE) during 3 months before participate in this study.
Exclusion Criteria:
Pregnancy
Onset of serious spinal pathology: spinal fracture, spinal tumor or spinal infection.
Cauda equina syndrome.
Presented at least 2 out of 3 signs of neurological deficit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rungthip Chalermsan
Organizational Affiliation
Faculty of Associated Medical Sciences, Khon Kaen University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Associated Medical Sciences, Khon Kaen University
City
Muang Khon Kaen
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain
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