- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237724
Effects of Motor Imagery on Pain, Function, Endurance, Kinesiophobia and Sleep Quality in Patients With Non-specific Low Back Pain
Non-specific low back pain (NSLBP) is one of the most common musculoskeletal disorders all over the world and a leading cause of disability. It affects individuals across different age groups and is typically characterized by pain, stiffness, and functional limitations that reduce physical activity and overall quality of life. Among established clinical approaches, Core exercises are frequently used in the management of LBP, reducing pain and improving functionality by stabilizing the spine. However, despite their widespread use, there is limited evidence on the effectiveness of combining core exercises with cognitive interventions, such as action observation.
Motor imagery (MI) and action observation (AO) offer practical, low-cost approaches that can be easily integrated into rehabilitation programs. Motor imagery involves the individual visualizing the physical movement in their mind without performing it, while action observation involves learning specific movements by observing them. These techniques can strengthen the effectiveness of physical exercises by increasing neuromuscular activation. However, it has been reported that motor imagery-based cortical processes facilitate the reorganization of sensory-motor functions during daily activities in LBP patients. Studies in this area are quite limited. The effectiveness of action observation therapy, which is primarily effective in neurological conditions, has not been investigated in non-specific low back pain. Therefore, in this study, the effects of combining action observation therapy with a core exercise program, Pain, Function, Endurance, Kinesiophobia, and Sleep Quality in patients with non-specific low back pain will be examined.
The study aims to investigate the effects of combining action observation therapy with core exercises compared with core exercises alone in patients with NSLBP. Patients attending Fizyowell physiotherapy and Healthy Services clinic who meet the inclusion criteria will be included in the study. This study seeks to explore the potential benefits of integrating cognitive techniques into a conventional exercise-based rehabilitation for NSLBP.
To establish participant eligibility before the study begins, a standardized demographic data form will be collected from all subjects who volunteered to participate in the study, including gender, age, height, weight, education, marital status, chronic diseases and medication use, smoking, and alcohol use. In addition, the Mini-Mental State Examination (MMSE) will be used to assess the patient's mental state, determine the ability to understand and follow instructions, and identify cognitive disorders that may make it difficult to perform mental interventions. The Movement Imagery Questionnaire-3 (MIQ-3) will be used to determine each participant's motor imagery ability. Once eligibility is confirmed, baseline assessments will be conducted, including pain intensity measured by the Visual Analog Scale (VAS), functional disability assessed using the Oswestry Low Back Pain Disability Index Questionnaire, kinesiophobia evaluated with the Tampa Scale for Kinesiophobia (TSK), core endurance tested through standardized endurance measures, and sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI).
After the initial evaluation, the treatment program will be started. Advances in the treatment method specific to the groups they belong to are explained in detail below.
Treatment:
After the first evaluation, the core exercise program will be applied to the patients in Group 1, 3 days per week for 6 weeks. All sessions will be conducted under the supervision of a physiotherapist at the clinic.
Group 2: Conservative Treatment + Action Observation Program. This group will have action observation therapy in addition to the core exercise program. The patients in this group will receive an action observation therapy for 6 minutes before each exercise therapy session. They will watch videos of 2 different activities, the duration of each video is 3 minutes, and they were recorded from 3 planes (frontal, back, and lateral).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Sara Hamdi Shalabi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being 18 years of age or older,
- Being a volunteer.
- Having nonspecific chronic low back pain for three months or more.
- No obvious structural or anatomical abnormality that could explain the pain.
- Scoring 24 or more out of 30 on the Mini-Mental State Examination.
- Those who score high in terms of imagery ability on the MIQ-3 questionnaire.
- Not having any pathology in vision or hearing
Exclusion Criteria:
- pregnancy
- Having a painful spinal deformity.
- Having a spinal surgery
- Having a mental illness and/or communication problem.
- Having pain radiating to the lower extremity.
- Having any back disease diagnosed by a specialist physician other than non-specific chronic back pain
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 |
|---|---|
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Active Comparator: Core Exercise Program
Participants receive supervised core exercise therapy 3 times per week for 6 weeks.
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Experimental: Core Exercise + Action Observation
Participants receive the same core exercise therapy plus an action observation session before each treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Level
Time Frame: Baseline (Day 1) and After 6 Weeks of Treatment
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The Visual Analog Scale (VAS) is an important instrument used for measuring the severity of low back pain at rest and during physical activity.
It provides a simple, validated method of transforming subjective pain experiences into numerical values suitable for statistical analysis.
Participants will be asked to rate their pain intensity on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "unbearably severe pain".
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Baseline (Day 1) and After 6 Weeks of Treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functionality Level
Time Frame: Baseline (Day 1) and Week 6.
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Oswestry Low Back Pain Disability Index Questionnaire (ODI) The Oswestry Questionnaire is a widely used tool to assess the level of functional disability in patients with low back pain.
It consists of 10 sections: pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and degree of pain change.
Each section has 6 response options scored from 0 to 5, with higher scores indicating greater disability.
The total score ranges from 0 to 50, which may be converted to a percentage (0-100% disability).
A higher total score reflects a higher level of functional disability.
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Baseline (Day 1) and Week 6.
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Core Muscle Endurance
Time Frame: At baseline and after 6 weeks of intervention
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Trunk Flexor Test - Trunk Extensor Test -Side Bridge Test - Prone plank Test
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At baseline and after 6 weeks of intervention
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Kinesiofobia Level
Time Frame: Baseline and Week 6.
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"Kinesiophobia" is a term referring to the fear of movement and physical activity due to fear of reinjury, pain or the belief that any physical effort may lead to further harm or complications.
The Tampa Scale for Kinesiophobia (TSK) is a validated 17-item questionnaire used to assess the fear of movement and reinjury.
Each item is scored from 1 (strongly disagree) to 4 (strongly agree), producing a total score range of 17 to 68.
Higher scores indicate greater fear of movement (higher kinesiophobia).
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Baseline and Week 6.
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Sleep Quality
Time Frame: From the start of treatment until 6 week after the end of treatment
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Pittsburgh Sleep Quality Index (PSQI): The Pittsburgh Sleep Quality Index is a validated 19-item self-report questionnaire assessing sleep quality over the past month. It produces a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. |
From the start of treatment until 6 week after the end of treatment
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Salik Sengul Y, Kaya N, Yalcinkaya G, Kirmizi M, Kalemci O. The effects of the addition of motor imagery to home exercises on pain, disability and psychosocial parameters in patients undergoing lumbar spinal surgery: A randomized controlled trial. Explore (NY). 2021 Jul-Aug;17(4):334-339. doi: 10.1016/j.explore.2020.02.001. Epub 2020 Feb 22.
- Ozturk O, Bombaci H, Kececi T, Algun ZC. Effects of additional action observation to an exercise program in patients with chronic pain due to knee osteoarthritis: A randomized-controlled trial. Musculoskelet Sci Pract. 2021 Apr;52:102334. doi: 10.1016/j.msksp.2021.102334. Epub 2021 Jan 24.
- Salik Sengul Y, Yilmaz A, Kirmizi M, Kahraman T, Kalemci O. Effects of stabilization exercises on disability, pain, and core stability in patients with non-specific low back pain: A randomized controlled trial. Work. 2021;70(1):99-107. doi: 10.3233/WOR-213557.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 61351342/020-65
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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