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Completed

NCT Number: NCT02645760

Effectiveness of Core Stabilization Exercise 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Associated Medical Sciences, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Core stabilization exercise

Other

7-weeks of core stabilization exercise

conventional treatment

Other

7-weeks of conventional treatment include therapeutic ultrasound and hot pack

Primary outcomes

  1. Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7

    Time frame: baseline an 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 outcomes

  1. Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7

    Time frame: baseline and 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

  2. Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7

    Time frame: baseline and 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)

  3. Change From Baseline in Repositioning Error on Repositioning Test at Week 7

    Time frame: baseline and 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)

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Acronym: CSENSLBP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2016
Registry last updated
Oct 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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