Telerehabilitation-based Motor Imagery in Nonspecific Low Back Pain

Motor Imagery Clinical Trial

Official title:

Investigation of the Effects of Telerehabilitation-based Motor Imagery Training in Patients With Nonspecific Low Back Pain: A Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049772
• Other study ID #: 6385-GOAEK
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: June 15, 2024

Study information

• Verified date: March 2024
• Source: Izmir Katip Celebi University
• Contact: Muhammed Z UZ, Lecturer
• Phone: +905326369774
• Email: fzt32[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low back pain is a common problem in society and causes loss of workforce. Its lifetime prevalence reaches 80% and annual hospital admission rates in the adult population reach 15%.Most studies on motor imagery suggested the effects of motor imagery are related to neuroplastic changes in the brain. Studies have shown that similar brain regions are activated during motor imagery and real movement. However, the level of evidence about the effect of motor imagery on autonomic functions is limited. Today, interest in telerehabilitation has increased due to the Covid-19 pandemic.

The aim of this study is to examine the effects of telerehabilitation-based motor imagery training in patients with non-specific low back pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those who can read and write

• Patients who have not undergone surgery

• Those with a body mass index less than 30 m2/kg

• To have sufficient computer knowledge to participate in the study or to have a relative who can help in this regard

• Having a computer and active internet connection at home

Exclusion Criteria:

• Medically uncontrolled and uncooperative patients

• Patients who have undergone surgery to the lumbar region

• History of falling in the last 6 months

• Those with serious orthopedic, vascular, neurological, psychiatric problems affecting balance

• Active malignancy

• Pregnancy

• Having severe vision and hearing problems

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Motor Imagery

Intervention

Behavioral:
• Telerehabilitation-based motor imagery training
10 weeks of motor imagery training and stabilization exercises.
• Stabilization exercises group
10 weeks of stabilization exercises.

Locations

Country	Name	City	State
Turkey	Bilge Kara	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Katip Celebi University	Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the methods - minimum recruitment rate	A minimum recruitment rate of 10 participants per month will be accepted as feasiable.	through Study Completion, an Average of 10 Months
Primary	Feasibility of the methods - minimum retention rate	A target retention rate of 80% will be accepted as feasiable	through Study Completion, an Average of 10 Months
Primary	Feasibility of the methods - minimum adherence rate	A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.	through Study Completion, an Average of 10 Months
Primary	Feasibility of the methods - adverse events	A record sheet was prepared for possible adverse events during the tests and intervention. It includes information about seriousness, expectedness, severity, causality, time, duration of the event and clinical action taken. The numbers of adverse events will be reported	through Study Completion, an Average of 10 Months
Secondary	Kinesthetic and Visual Imagery Questionnaire	The Kinesthetic and Visual Imagery Questionnaire-Short Form consists of 10 movements in total, measuring 5 visual and 5 kinesthetic visualization skills, developed to determine the extent to which individuals visualize and feel the imagined movements. The questionnaire is not a self-report scale, but is administered with an evaluator. All movements are evaluated in the sitting position. Higher scores indicate greater visual clarity or intensity of sensations.	Change from Baseline at 10 Weeks
Secondary	Movement Imagery Questionnaire-Revised	The Movement Imagery Questionnaire-Revised assesses visual and kinesthetic movement imagery ability and is comprised of four visual and four kinesthetic items. Each item entails performing a movement, visually or kinesthetically imaging that movement and then rating the ease or difficulty of generating that image on a 7-point scale from 1 = very hard to see/feel to 7 = very easy to see/feel. Higher scores indicate higher visual or kinesthetic movement imagery ability.	Change from Baseline at 10 Weeks
Secondary	Oswestry Disability Questionnaire,	The Oswestry Disability Questionnaire, which allows the patient to self-evaluate, is used to evaluate the limitations that patients compare in daily life. The total score ranges from 0 to 100, and a high score indicates an increased level of disability.	Change from Baseline at 10 Weeks
Secondary	International Physical Activity Questionnaire	It is grouped as Low (Category 1), Medium (Category 2), Very active (Category 3). Calculation is made on a weekly basis as MET level x minutes of activity.	Change from Baseline at 10 Weeks
Secondary	VISUAL ANALOGUE SCALE	Visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.	Change from Baseline at 10 Weeks
Secondary	Wechsler Adult Intelligence Scale- Revised	In this test, the patient is asked to repeat the digits read to him, one second apart, in the same order backwards, starting from the last. The test starts with a two-digit number sequence, and when repeated correctly, one digit is increased and continues until the seventh sequence of eight numbers. The patient must repeat at least one of the two sequences of numbers of the same length in the correct order in order to progress in the test. Scoring is based on the total number of correct and repetitions.	Change from Baseline at 10 Weeks
Secondary	d2 Attention-Tests	The test form consists of 14 lines, each with 47 marked letters. There are 16 letters "p" and "d" marked with one, two, three or four lowercase lines in each line. The patient is asked to find and cross out the letters "d" with only two signs. For each line, the patient is given 20 seconds.	Change from Baseline at 10 Weeks
Secondary	Trail Making Test	The Trail Making test consists of two parts. In Part A, the patient is asked to put together the circles with numbers in the correct order, which are scattered on the test form. In Part B, the patient is asked to combine the circles, which are scattered on the test form and contain both numbers and letters, in the correct order (1-A, 2-B, 3-C).	Change from Baseline at 10 Weeks
Secondary	Pittsburg Sleep Quality Index	The Pittsburg Sleep Quality Index evaluates sleep quality over the past month. 19 of the 24 questions included in the Pittsburg Sleep Quality Index are self-report questions. Five questions are answered by the spouse or a roommate. The 18 items participating in the scoring are grouped into 7 component scores. Each item is evaluated over 0-3 points. The sum of the 7 component scores gives the overall Pittsburg Sleep Quality Index score.	Change from Baseline at 10 Weeks
Secondary	SF-36 Short Fotm	The SF-36 has a total of 8 sub-components: physical function, physical role limitation, pain, general perception of health, vitality (energy), social function, emotional role limitation, and mental health. The answers to the questions answered by the participants are scored between 0-100. A high score indicates a good quality of life, and a low score indicates a poor quality of life.	Change from Baseline at 10 Weeks