Effectiveness of Core Stabilization Exercise in Patients With Subacute Non-Specific Low Back Pain (CSENSLBP)

Comparison of Core Stabilization Exercise and Physical Therapy Treatment in Patients With Subacute Non-specific Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Core stabilization exercise; Other: Conventional treatment

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen
    • Muang Khon Kaen, Khon Kaen, Thailand, 40002
      • Faculty of Associated Medical Sciences, Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Core stabilization exercise; 7-weeks of core stabilization exercise	Other: Core stabilization exercise; 7-weeks of core stabilization exercise
Active Comparator: conventional treatment; 7-weeks of conventional treatment include therapeutic ultrasound and hot pack	Other: Conventional treatment; 7-weeks of conventional treatment include therapeutic ultrasound and hot pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline an week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline and week 7
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)	baseline and week 7
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)	baseline and week 7

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Study Director: Rungthip Chalermsan, Faculty of Associated Medical Sciences, Khon Kaen University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 31, 2015
• First Submitted That Met QC Criteria: January 1, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Estimate): October 6, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KKU-571H106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES