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

Low Back Pain Clinical Trial

— CSENSLBP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02645760
• Other study ID #: KKU-571H106
• Status: Active, not recruiting
• Phase: N/A
• First received: December 31, 2015
• Last updated: January 13, 2016
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2015
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Core stabilization exercise
7-weeks of core stabilization exercise
• Conventional treatment
7-weeks of conventional treatment include therapeutic ultrasound and hot pack

Locations

Country	Name	City	State
Thailand	Faculty of Associated Medical Sciences, Khon Kaen University	Muang Khon Kaen	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain intensity at rest	Pain intensity at rest (11-point NRS) will be assessed at baseline before randomization and assess again at 4-weeks of treatment, at 1 day after 7 weeks of treatment (accumulative effect or short-term effect), and 1-month after the last treatment session (intermediate-term effects).	baseline, at 4-weeks of treatment, at 1-day after 7 weeks of treatment, 1-month follow-up	Yes
Secondary	Functional disability	functional disability (RMDQ) will be assessed at baseline before randomization and assess again at 4-weeks of treatment, at 1 day after 7 weeks of treatment (accumulative effect or short-term effect), and 1-month after the last treatment session (intermediate-term effects).	baseline, at 4-weeks of treatment, at 1-day after 7 weeks of treatment, 1-month follow-up	Yes
Secondary	Back range of motion	Back range of motion (MMST) will be assessed at baseline before randomization and assess again at 4-weeks of treatment, at 1 day after 7 weeks of treatment (accumulative effect or short-term effect), and 1-month after the last treatment session (intermediate-term effects).	baseline, at 4-weeks of treatment, at 1-day after 7 weeks of treatment, 1-month follow-up	Yes
Secondary	Ability to perform re-positioning tasks	Ability to perform re-positioning tasks or lumbar motor control (RPS) will be assessed at baseline before randomization and assess again at 4-weeks of treatment, at 1 day after 7 weeks of treatment (accumulative effect or short-term effect), and 1-month after the last treatment session (intermediate-term effects).; The method of Repositioning (RPS): Sitting with feet supported, Lower back in neutral, 10 cm tape-measure, center of tape at S1, and marked by laser pointer. Lower back movement from max anterior-max posterior tilt. Subject reposition of Lower back (neutral), distance measured between center of tape at S1 and laser pointer.	baseline, at 4-weeks of treatment, at 1-day after 7 weeks of treatment, 1-month follow-up	Yes