Condition or disease | Intervention/treatment | Phase |
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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 |
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 : | 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 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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.
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.
Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erkan Sümer, MD | 03123051576 | erkansmr@hacettepe.edu.tr | |
Contact: Özlem Ülger, PhD | 03123051576 ext 128 | ozlemulger@yahoo.com |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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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. |
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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 |
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Condition ICMJE | Back Pain Without Radiation | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |