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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03527524
Other study ID # MahidolU_Wunpen1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date June 2015

Study information

Verified date May 2018
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.


Description:

For Patient Registries:

The participant was screened for inclusion criteria and was asked to sign the informed consent prior to participate. A randomized control trial was performed with participants randomly divided into one of the two treatment groups: core stabilization exercise with ball and core stabilization exercise without ball by using sealed envelopes.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years to 68 Years
Eligibility Inclusion Criteria:

1. Male and female with low back pain (LBP) > 3 months

2. Body mass index (BMI) = 18-25 kg/m2

3. Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)

4. Willing and able to perform exercise programs

5. No cognitive impairment

6. Age at least 19 years

Exclusion Criteria:

1. Having experiences in the core stabilization exercise and Swiss ball exercises

2. Past history of back and abdomen surgery

3. Recent fractures of spine, hip or lower limb

4. Current use of steroids or any other drugs for resolving back pain

5. Red flags (fractures, cancer, infection, cauda equine syndrome)

6. Pregnancy

7. Neuromuscular or respiratory disorders

8. Rheumatologic disorders

9. Hip and knee stiffness

10. Pain intensity > 60 of 100 mm assessed by the VAS

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise with ball
exercise with ball
exercise without ball
exercise without ball

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain scale a 0-100 mm of horizontal line (Visual analog scale) assessing pain intensity - reported the distance measured in millimeters from the left hand side of this line to the point that participant marked 4 weeks
Secondary Questionnaire scores of functional disability measure Thai modified Oswestry Disability Low Back Pain Disability Questionnaire 4 weeks
Secondary Levels of lumbar stability isometric abdominal contraction assessing lumbar stability 4 weeks
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