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Different Learning Methods of Motor Control Exercises

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ClinicalTrials.gov Identifier: NCT03984903
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Utku BERBEROĞLU, Hacettepe University

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.


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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

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984903


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

Sponsors and Collaborators
Hacettepe University
  Study Documents (Full-Text)

Documents provided by Utku BERBEROĞLU, Hacettepe University:

Publications:
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Responsible Party: Utku BERBEROĞLU, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier: NCT03984903     History of Changes
Other Study ID Numbers: KA-180060
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Utku BERBEROĞLU, Hacettepe University:
Back Pain without Radiation
Low Back Pain, Mechanical

Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms