- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06859645
Motor Imagery Training in Non-Specific Low Back Pain
Effects of Telerehabilitation-Based Motor Imagery Training on Pain, Trunk Endurance, Functional Capacity, and Psychosocial Parameters in People With Non-Specific Low Back Pain: A Randomized Controlled Trial
Low back pain is a significant global health issue, affecting a large proportion of the population at some point in their lives. Among the different types of low back pain, non-specific low back pain is the most common. Chronic low back pain has been shown to impact trunk endurance, functional capacity, fatigue, anxiety, and depression levels.
Neuroscience-based studies aimed at improving pain management have demonstrated that chronic pain is associated with not only peripheral changes but also central changes. These central changes include abnormalities in the distribution of sensory cortical processing, disinhibition of the motor cortex, and disturbances in body schema perception.
Studies have shown that motor imagery training, defined as the mental simulation of movement without actual execution, functions as a cortical-level training method and has positive effects on impaired body schema perception, thereby reducing pain. A review of the literature indicates that motor imagery training contributes to the treatment of pathological pain syndromes such as complex regional pain syndrome, brachial plexus avulsion injury, phantom limb pain, distal radius fracture, and stroke by modulating cortical mechanisms. However, no randomized controlled trials have investigated the effectiveness of adding motor imagery training to exercise therapy in individuals with non-specific chronic low back pain, specifically regarding its impact on physical function and psychosocial parameters.
The aim of this study is to investigate the effects of a motor imagery training protocol, applied in addition to exercise therapy, on pain, physical, and psychosocial parameters in individuals with non-specific chronic low back pain.
A total of 32 individuals with chronic non-specific low back pain will be included in the study. Participants will be randomly assigned to either the intervention or control group. All participants will receive telerehabilitation-based exercise therapy under the supervision of a physiotherapist. In addition to the exercise therapy, participants in the intervention group will undergo asynchronous motor imagery training every day for eight weeks, while the control group will receive only exercise therapy.
Assessments will be conducted three times: before treatment, at the end of the 8-week intervention, and at the 12th week follow-up. All assessments will be performed through a telerehabilitation-based approach. The study will evaluate participants' pain, fatigue, disability level due to low back pain, anxiety and depression levels, and physical function.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Bilgi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18 and 55 years old
- Having a history of low back pain persisting for at least three months
- Experiencing recurrent episodes of low back pain
- Having a low back pain intensity score of 4 or higher on the Numeric Pain Rating Scale (NRS) out of 10 during both rest and activity
- Having the ability to use a computer, tablet, or smartphone at a level sufficient to participate in assessments and treatment sessions via videoconference, or having a caregiver who can assist with this
- Volunteering to participate in the study
- Being able to read and understand Turkish
Exclusion Criteria:
- A history of spinal surgery
- Having traumatic low back injuries
- Presence of severe comorbidities (neurological, neuromuscular, cardiological, psychiatric)
- Presence of tumoral conditions
- Having visual or hearing impairments
- Presence of cognitive impairments
- Receiving physiotherapy for low back pain within the last six months
- Changes in pain medication within the last two months
- Receiving additional treatments beyond routine care
- Being pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motor Imagery and Exercise Group
Participants in the intervention group will follow a pre-designed motor imagery program in addition to the prescribed exercise training for eight weeks.
This program will include exercise videos specifically targeting the lumbar region, along with synchronized audio recordings providing detailed explanations of the exercises.
The exercise videos will initially consist of simple exercises and will progressively advance to more complex movements over the course of the intervention.
Participants will receive new exercise videos weekly.
Each session will last approximately 20-25 minutes, and participants will be required to complete the program daily.
|
In addition to the prescribed exercise training, participants in the intervention group will follow a pre-designed motor imagery program for eight weeks, practicing daily.
This program will include pre-recorded exercise videos specifically targeting the lumbar region, along with synchronized audio recordings providing detailed explanations of the exercises.
All participants will receive telerehabilitation-based exercise training under the supervision of a physiotherapist for eight weeks.
The exercise program will be delivered via videoconferencing as part of a telerehabilitation-based approach.
The exercises, conducted under the physiotherapist's supervision, will consist of flexibility and stabilization exercises targeting the lumbar region and will last approximately 25 minutes per session.
|
|
Active Comparator: Exercise Group
Participants in the control group will receive only telerehabilitation-based exercise training under the supervision of a physiotherapist, twice a week for eight weeks.
|
All participants will receive telerehabilitation-based exercise training under the supervision of a physiotherapist for eight weeks.
The exercise program will be delivered via videoconferencing as part of a telerehabilitation-based approach.
The exercises, conducted under the physiotherapist's supervision, will consist of flexibility and stabilization exercises targeting the lumbar region and will last approximately 25 minutes per session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Scale
Time Frame: Baseline, at 8 week, at 12 week
|
The severity of general low back pain experienced by the participants in the last two days will be assessed numerically using the Numeric Pain Scale.
Participants will be informed that a score of 0 represents "no pain at all," while a score of 10 represents "the most unbearable pain."
Pain severity will be recorded numerically on a scale from 0 to 10.
|
Baseline, at 8 week, at 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: Baseline, at 8 week, at 12 week
|
The "Oswestry Disability Index" will be used to assess the level of disability related to low back pain among participants.
This index evaluates the impact of low back pain on daily activities through 10 questions, each scored between 0 and 5, covering aspects such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and changes in pain severity.
A lower score indicates a higher quality of life.
The validity and reliability of the Turkish version of the index have been established, with a reported Cronbach's alpha of 0.91.
|
Baseline, at 8 week, at 12 week
|
|
Fatigue Severity Scale
Time Frame: Baseline, at 8 week, at 12 week
|
The "Fatigue Severity Scale," commonly used in clinical and experimental studies, will be employed to determine participants' fatigue levels.
The scale consists of nine questions, each scored from 1 to 7 (1: strongly disagree, 7: strongly agree).
The total score is obtained by summing the scores of all items and calculating the average.
Higher scores indicate greater fatigue.
This scale was developed and adapted into Turkish.
|
Baseline, at 8 week, at 12 week
|
|
Hospital Anxiety and Depression Scale
Time Frame: Baseline, at 8 week, at 12 week
|
The "Hospital Anxiety and Depression Scale" will be used to evaluate participants' levels of anxiety and depression.
This scale is utilized to determine the risk, severity, and level of anxiety and depression in individuals.
The HADS consists of a total of 14 self-report items, divided into two subscales: seven related to anxiety and seven related to depression.
Items are rated on a four-point Likert scale ranging from 0 to 3. Higher scores indicate more severe symptoms.
|
Baseline, at 8 week, at 12 week
|
|
Sit-up Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "Sit-up Test" will be used to assess trunk endurance among participants.
This test measures the strength and endurance of abdominal muscles.
Participants will begin in a supine position with knees flexed at approximately 140 degrees, feet flat on the floor, legs slightly abducted, arms parallel to the trunk with palms facing downward.
They will be instructed to perform sit-up movements by extending their arms forward and then returning to the starting position.
The number of sit-ups completed within one minute will be recorded.
Time will be tracked using a stopwatch.
The validity and reliability of remote application of this test have been established.
|
Baseline, at 8 week, at 12 week
|
|
Modified Push-up Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "Modified Push-up Test" will be conducted to assess trunk endurance.
Participants will assume a prone position with hands positioned at shoulder level, elbows flexed, and the body aligned to allow for elbow extension and flexion.
They will be asked to lift their head, shoulders, and trunk off the ground by fully extending their elbows and to repeat this movement for 40 seconds.
The number of completed push-ups within this duration will be recorded.
The validity and reliability of remote application of this test have been confirme.
|
Baseline, at 8 week, at 12 week
|
|
Plank Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "Plank Test" will be used to evaluate trunk endurance.
Participants will be positioned in a prone posture, resting on their forearms and toes, with their pelvis elevated and their body forming a straight line parallel to the ground.
They will be instructed to maintain this position for as long as possible.
The duration (in seconds) until the participant can no longer hold the position will be recorded.
The validity and reliability of remote application of this test have been verified.
|
Baseline, at 8 week, at 12 week
|
|
Side Bridge Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "Side Bridge Test" will be used to assess trunk endurance.
Participants will be instructed to lie on their side with their legs extended and the upper arm placed across the chest, touching the opposite shoulder.
The supporting elbow will be flexed, allowing weight to be distributed through the elbow and forearm.
Participants will be asked to lift their hips off the ground while maintaining a straight body alignment, supported by the elbow and feet.
The test will end when the participant loses the correct posture, and the duration (in seconds) of holding the position will be recorded.
This test will be performed bilaterally.
The validity and reliability of remote application of this test have been confirmed.
|
Baseline, at 8 week, at 12 week
|
|
Timed Up and Go Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "Timed Up and Go Test" will be used to assess participants' functional capacity.
Participants will be asked to stand up from a chair with armrests, walk three meters, turn around, return to the chair, and sit down.
The total time taken to complete this task will be measured.
The validity and reliability of remote application of this test have been established.
|
Baseline, at 8 week, at 12 week
|
|
30-Second Chair Stand Test
Time Frame: Baseline, at 8 week, at 12 week
|
The "30-Second Chair Stand Test" will be used to assess participants' functional capacity.
Participants will use a chair with a seat height of 45-47 cm, ensuring their feet are in contact with the ground.
Beginning in a seated position with arms crossed over the chest, they will be asked to stand up and sit down as many times as possible within 30 seconds.
The number of completed repetitions will constitute the test score.
The participant must fully extend their hips and knees while standing.
The validity and reliability of remote application of this test have been confirmed.
|
Baseline, at 8 week, at 12 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MotorImagery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Ache Laboratorios Farmaceuticos S.A.Unknown
Clinical Trials on Motor imagey training
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
University of California, San DiegoCompletedAutism Spectrum Disorder | Autistic DisorderUnited States
-
University of PlymouthRecruiting
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtCompleted
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanRecruitingChronic StrokeTaiwan
-
University Hospital TuebingenParkinson StiftungNot yet recruitingMild Cognitive Impairment (MCI) | PARKINSON DISEASE (Disorder)Germany
-
Riphah International UniversityCompleted
-
Lev-Hasharon Mental Healtlh CenterTel Aviv University; University of Haifa; Institute of Physical Education and...Unknown
-
National Cheng-Kung University HospitalNot yet recruitingDevelopmental Delay | Preterm Children