Back Pain Without Radiation Clinical Trial
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
Verified date | February 2023 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effects of self-learning exercise from multimedia content on pain and disability in patients with low back pain.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Samanpazari |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
At baseline, eighth week and third month | |
Primary | 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. |
At baseline, eighth week and third month | |
Primary | 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. |
At eighth week and third month | |
Secondary | Change from Baseline Walking Parameters at Eight Week and Third Month | Mean Step Length and Total Walking Distance in Six Minute Walk Test | At baseline, eighth week and third month |
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