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Different Learning Methods of Motor Control Exercises

Primary Purpose

Back Pain Without Radiation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multimedia Learning of Exercises
Face-to-face Learning of Exercises
Manual Therapy
Home Exercise Program
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Without Radiation focused on measuring Back Pain without Radiation, Low Back Pain, Mechanical

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Face-to-face Learning Group

Multimedia Learning Group

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline Pain Level at Eight 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
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
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

Change from Baseline Walking Parameters at Eight Week and Third Month
Mean Step Length and Total Walking Distance in Six Minute Walk Test

Full Information

First Posted
May 30, 2019
Last Updated
February 27, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03984903
Brief Title
Different Learning Methods of Motor Control Exercises
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Without Radiation
Keywords
Back Pain without Radiation, Low Back Pain, Mechanical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Face-to-face Learning Group
Arm Type
Active Comparator
Arm Title
Multimedia Learning Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Multimedia Learning of Exercises
Intervention Description
Patients learn exercise from multimedia content.
Intervention Type
Other
Intervention Name(s)
Face-to-face Learning of Exercises
Intervention Description
Physiotherapist teach exercises to patients
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area
Intervention Type
Other
Intervention Name(s)
Home Exercise Program
Intervention Description
Patients do at least 20 minutes motor control exercise in a day at home.
Primary Outcome Measure Information:
Title
Change from Baseline Pain Level at Eight Week and Third Month
Description
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.
Time Frame
At baseline, eighth week and third month
Title
Change from Baseline Disability Score Level at Eight Week and Third Month
Description
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.
Time Frame
At baseline, eighth week and third month
Title
Change in Exercise Adherence Level between Eight Week and Third Month
Description
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.
Time Frame
At eighth week and third month
Secondary Outcome Measure Information:
Title
Change from Baseline Walking Parameters at Eight Week and Third Month
Description
Mean Step Length and Total Walking Distance in Six Minute Walk Test
Time Frame
At baseline, eighth week and third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Samanpazari
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
21982256
Citation
Balague F, Mannion AF, Pellise 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.
Results Reference
background
PubMed Identifier
16550448
Citation
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(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
Results Reference
background
PubMed Identifier
26742533
Citation
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;2016(1):CD012004. doi: 10.1002/14651858.CD012004.
Results Reference
background

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Different Learning Methods of Motor Control Exercises

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