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

NCT02645760 | Completed Results DMC

• 1 other identifier: KKU-571H106
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  baseline and week 7

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

  baseline and week 7

• Change From Baseline in Repositioning Error on Repositioning Test at Week 7

  baseline and week 7

Study Arms (2)

Core stabilization exercise

ACTIVE COMPARATOR

7-weeks of core stabilization exercise

Other: Core stabilization exercise

conventional treatment

ACTIVE COMPARATOR

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

Other: Conventional treatment

Interventions

Core stabilization exercise OTHER

7-weeks of core stabilization exercise

Core stabilization exercise

Conventional treatment OTHER

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

conventional treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Associated Medical Sciences, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rungthip Chalermsan
• Organization: Khonkaen University

chalermsanrungthip@gmail.com

+66 835603675

Study Officials

• Rungthip Chalermsan

  Faculty of Associated Medical Sciences, Khon Kaen University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Associated Medical Sciences

Study Record Dates

• First Submitted: December 31, 2015
• First Posted: January 5, 2016
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)