Telerehabilitation-based Motor Imagery in Nonspecific Low Back Pain

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Telerehabilitation-based motor imagery training

Stabilization exercises group

About this trial

This is an interventional treatment trial for Motor Imagery focused on measuring non-specific low back pain, telerehabilitation, motor imagery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Bilge KaraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Telerehabilitation-based motor imagery group

Stabilization Exercises group

Healthy control group

Arm Description

Behavioral: Telerehabilitation-based motor imagery group Participants in the Telerehabilitation-based motor imagery group will imagine for the lumbar region exercises (e.g. bridges, knee-to-chest stretches, pelvic tilts) in the sessions in home using the study audio-video motor imagery script for 2 times per week; 30 min per day for 10 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). In addition, the participants will be given stabilization exercises In addition, the participants will be given stabilization exercises for 10 weeks for 40 minutes, 2 days a week.

Behavioral: Stabilization Exercises group An exercise program consisting of lumbar stabilization exercises for the participants will be planned for the pelvic ring muscles to develop the neutral lumbar spine. Co-contraction of the transversus abdominus muscle and the multifidus muscle will form the basis of the exercises. Stabilization exercises will be given for 10 weeks for 40 minutes, 2 days a week.

no specific intervention

Outcomes

Primary Outcome Measures

Feasibility of the methods - minimum recruitment rate

A minimum recruitment rate of 10 participants per month will be accepted as feasiable.

Feasibility of the methods - minimum retention rate

A target retention rate of 80% will be accepted as feasiable

Feasibility of the methods - minimum adherence rate

A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.

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

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT05049772

First Posted

September 8, 2021

Last Updated

September 11, 2023

Sponsor

Izmir Katip Celebi University

Collaborators

Dokuz Eylul University

1. Study Identification

Unique Protocol Identification Number

NCT05049772

Brief Title

Telerehabilitation-based Motor Imagery in Nonspecific Low Back Pain

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 8, 2022 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

June 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Izmir Katip Celebi University

Collaborators

Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motor Imagery

Keywords

non-specific low back pain, telerehabilitation, motor imagery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telerehabilitation-based motor imagery group

Arm Type

Experimental

Arm Description

Behavioral: Telerehabilitation-based motor imagery group Participants in the Telerehabilitation-based motor imagery group will imagine for the lumbar region exercises (e.g. bridges, knee-to-chest stretches, pelvic tilts) in the sessions in home using the study audio-video motor imagery script for 2 times per week; 30 min per day for 10 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week). In addition, the participants will be given stabilization exercises In addition, the participants will be given stabilization exercises for 10 weeks for 40 minutes, 2 days a week.

Arm Title

Stabilization Exercises group

Arm Type

Active Comparator

Arm Description

Behavioral: Stabilization Exercises group An exercise program consisting of lumbar stabilization exercises for the participants will be planned for the pelvic ring muscles to develop the neutral lumbar spine. Co-contraction of the transversus abdominus muscle and the multifidus muscle will form the basis of the exercises. Stabilization exercises will be given for 10 weeks for 40 minutes, 2 days a week.

Arm Title

Healthy control group

Arm Type

No Intervention

Arm Description

no specific intervention

Intervention Type

Behavioral

Intervention Name(s)

Telerehabilitation-based motor imagery training

Intervention Description

10 weeks of motor imagery training and stabilization exercises.

Intervention Type

Behavioral

Intervention Name(s)

Stabilization exercises group

Intervention Description

10 weeks of stabilization exercises.

Primary Outcome Measure Information:

Title

Feasibility of the methods - minimum recruitment rate

Description

A minimum recruitment rate of 10 participants per month will be accepted as feasiable.

Time Frame

through Study Completion, an Average of 10 Months

Title

Feasibility of the methods - minimum retention rate

Description

A target retention rate of 80% will be accepted as feasiable

Time Frame

through Study Completion, an Average of 10 Months

Title

Feasibility of the methods - minimum adherence rate

Description

A target minimum adherence rate of 70% of the overall practice sessions will be accepted as feasiable.

Time Frame

through Study Completion, an Average of 10 Months

Title

Feasibility of the methods - adverse events

Description

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

Time Frame

through Study Completion, an Average of 10 Months

Secondary Outcome Measure Information:

Title

Kinesthetic and Visual Imagery Questionnaire

Description

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.

Time Frame