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Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain

Primary Purpose

Exercise

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise with ball
exercise without ball
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Exercise focused on measuring exercise

Eligibility Criteria

20 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    exercise with ball

    exercise without ball

    Arm Description

    The participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.

    The participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Questionnaire scores of functional disability measure
    Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
    Levels of lumbar stability
    isometric abdominal contraction assessing lumbar stability

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    May 4, 2018
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03527524
    Brief Title
    Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
    Official Title
    Effects of Core Stabilization Exercises With and Without Ball on Pain, Functional Disability and Level of Lumbar Stability in Patients With Non-specific Chronic Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exercise
    Keywords
    exercise

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    exercise with ball
    Arm Type
    Experimental
    Arm Description
    The participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.
    Arm Title
    exercise without ball
    Arm Type
    Other
    Arm Description
    The participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    exercise with ball
    Intervention Description
    exercise with ball
    Intervention Type
    Other
    Intervention Name(s)
    exercise without ball
    Intervention Description
    exercise without ball
    Primary Outcome Measure Information:
    Title
    Pain scale
    Description
    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
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Questionnaire scores of functional disability measure
    Description
    Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
    Time Frame
    4 weeks
    Title
    Levels of lumbar stability
    Description
    isometric abdominal contraction assessing lumbar stability
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female with low back pain (LBP) > 3 months Body mass index (BMI) = 18-25 kg/m2 Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold) Willing and able to perform exercise programs No cognitive impairment Age at least 19 years Exclusion Criteria: Having experiences in the core stabilization exercise and Swiss ball exercises Past history of back and abdomen surgery Recent fractures of spine, hip or lower limb Current use of steroids or any other drugs for resolving back pain Red flags (fractures, cancer, infection, cauda equine syndrome) Pregnancy Neuromuscular or respiratory disorders Rheumatologic disorders Hip and knee stiffness Pain intensity > 60 of 100 mm assessed by the VAS
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Apinkarn Jaroenlarp, MSc
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain

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