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出境医 / 临床实验 / Different Learning Methods of Motor Control Exercises

Different Learning Methods of Motor Control Exercises

Study Description
Brief Summary:
This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

Condition or disease Intervention/treatment Phase
Back Pain Without Radiation Other: Multimedia Learning of Exercises Other: Face-to-face Learning of Exercises Other: Manual Therapy Other: Home Exercise Program Not Applicable

Detailed Description:

For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.

So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Learning of Motor Control Exercises With Different Methods and Its Effects on Treatment Outcomes in Patients With Chronic Non-specific Low Back Pain: A Randomised Controlled Trial
Estimated Study Start Date : June 30, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 30, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Face-to-face Learning Group Other: Face-to-face Learning of Exercises
Physiotherapist teach exercises to patients

Other: Manual Therapy
Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area

Other: Home Exercise Program
Patients do at least 20 minutes motor control exercise in a day at home.

Experimental: Multimedia Learning Group Other: Multimedia Learning of Exercises
Patients learn exercise from multimedia content.

Other: Manual Therapy
Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area

Other: Home Exercise Program
Patients do at least 20 minutes motor control exercise in a day at home.

Outcome Measures
Primary Outcome Measures :
  1. Change from Baseline Pain Level at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]

    Full Scale Name: Visual Analog Scale

    Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.


  2. Change from Baseline Disability Score Level at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]

    Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0)

    The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.


  3. Change in Exercise Adherence Level between Eight Week and Third Month [ Time Frame: At eighth week and third month ]

    The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C.

    Section A, consists of 6 items not included in the scale scoring.

    Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high.

    Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.



Secondary Outcome Measures :
  1. Change from Baseline Walking Parameters at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]
    Mean Step Length and Total Walking Distance in Six Minute Walk Test


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic (>3 month), non-specific low back pain
  • 25- 55 years old
  • Have a capacity can understand exercise instructions (Montreal Cognitive Assessment > 21)
  • Being a computer literate

Exclusion Criteria:

  • Root nerve signs
  • Cauda equina syndrome
  • Fracture in the vertebra
  • Tumour
  • Have a neurologic disease
  • History of spine surgery
  • Knowing motor control exercises
  • Visual impairment
  • Hearing loss
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Erkan Sümer, MD 03123051576 erkansmr@hacettepe.edu.tr
Contact: Özlem Ülger, PhD 03123051576 ext 128 ozlemulger@yahoo.com

Sponsors and Collaborators
Hacettepe University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date June 13, 2019
Estimated Study Start Date  ICMJE June 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change from Baseline Pain Level at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]
    Full Scale Name: Visual Analog Scale Pain change will be measured throughout Study and Follow-up with Visual Analog Scale. This scale is a 100 millimeter line drawn horizontally on an A4 sheet of paper. The left end of the line shows "no pain at all", the right end shows "my pain is as bad as it could be", while the remaining part shows the intermediate values. So minimum score was 0, and maximum score was 100. The patient is asked to mark the severity of the pain on the chart. Validity and reliability were made. The minimal clinical significance difference in chronic low back pain was 20 millimeters.
  • Change from Baseline Disability Score Level at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]
    Full Scale Name: Turkish version of the Oswestry Disability Index (ODI) (2.0) The last reliable and validate Turkish Version of Oswestry Disability Index will be used. This version contains 10 multiple-choice questions that question how low back pain affects a person in his or her daily life. Each question has 6 options. As the disability increases, the score of each problem increases. In the worst case you can get 50 points. The last point is the patient's score 100.
  • Change in Exercise Adherence Level between Eight Week and Third Month [ Time Frame: At eighth week and third month ]
    The Exercise Adherence Rating Scale (EARS), which evaluates exercise compliance, will be administered 2 times to determine change at eight weeks and third month. This scale consists of 3 parts: A, B, C. Section A, consists of 6 items not included in the scale scoring. Section B consists 6 items, and every item have five point likert scale and describes how to do the recommended home exercise. Minimum point for this section 0, and maximum point is 24. The higher score shown exercise adherece is high. Section C is the section that evaluates the reason for the absence of compliance with the recommended home exercise and contains 10 items, every item have five point likert scale. Sections are calculated to result in a possible score between 0 and 40. The higher score shown exercise adherece is high.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
Change from Baseline Walking Parameters at Eight Week and Third Month [ Time Frame: At baseline, eighth week and third month ]
Mean Step Length and Total Walking Distance in Six Minute Walk Test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Learning Methods of Motor Control Exercises
Official Title  ICMJE Learning of Motor Control Exercises With Different Methods and Its Effects on Treatment Outcomes in Patients With Chronic Non-specific Low Back Pain: A Randomised Controlled Trial
Brief Summary This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
Detailed Description

For see the full effect of exercise treatment, exercise adherence should be high. In patients with chronic non-specific low back pain, the complex nature of the core-stabilization exercises decrease the exercise adherence. Some novel studies show that multimedia learning can increase efficiancy of complex skill learning and can be better from classic face to face learning.

So this study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Back Pain Without Radiation
Intervention  ICMJE
  • Other: Multimedia Learning of Exercises
    Patients learn exercise from multimedia content.
  • Other: Face-to-face Learning of Exercises
    Physiotherapist teach exercises to patients
  • Other: Manual Therapy
    Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area
  • Other: Home Exercise Program
    Patients do at least 20 minutes motor control exercise in a day at home.
Study Arms  ICMJE
  • Active Comparator: Face-to-face Learning Group
    Interventions:
    • Other: Face-to-face Learning of Exercises
    • Other: Manual Therapy
    • Other: Home Exercise Program
  • Experimental: Multimedia Learning Group
    Interventions:
    • Other: Multimedia Learning of Exercises
    • Other: Manual Therapy
    • Other: Home Exercise Program
Publications *
  • Balagué F, Mannion AF, Pellisé F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6. Review.
  • Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2:S192-300.
  • Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;(1):CD012004. doi: 10.1002/14651858.CD012004. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2019
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chronic (>3 month), non-specific low back pain
  • 25- 55 years old
  • Have a capacity can understand exercise instructions (Montreal Cognitive Assessment > 21)
  • Being a computer literate

Exclusion Criteria:

  • Root nerve signs
  • Cauda equina syndrome
  • Fracture in the vertebra
  • Tumour
  • Have a neurologic disease
  • History of spine surgery
  • Knowing motor control exercises
  • Visual impairment
  • Hearing loss
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984903
Other Study ID Numbers  ICMJE KA-180060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Utku BERBEROĞLU, Hacettepe University
Study Sponsor  ICMJE Hacettepe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hacettepe University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP