Non-specific Low Back PainNCT07237724
Effects of Motor Imagery on Pain, Function, Endurance, Kinesiophobia and Sleep Quality in Patients With Non-specific Low Back Pain
A study testing Core Exercise Program and Action Observation Therapy in people with Non-specific Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Core Exercise Program and Action Observation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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).
- Conditions
- Non-specific Low Back Pain
- Being tested
- Core Exercise Program, Action Observation Therapy
- Keywords
- action observation, Non-specific Low Back Pain, core exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Exercise ProgramOther
- The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist
- patients will receive core exercises program, 3 days per week
- Treatment duration is 6 weeks
Action Observation TherapyOther
- The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist
- patients will receive the same core exercises program as the Active comparator group, 3 days per week for 6 weeks
- This group will receive action observation therapy for 6 minutes before every exercise therapy session. they will watch videos of 2 different activates, the duration of each video is 3 minutes and will be recorded from 3 planes (front, back and lateral )
| Study group | Role | What they receive |
|---|---|---|
| Core Exercise Program | Active comparator | Participants receive supervised core exercise therapy 3 times per week for 6 weeks. Receives: Other: Core Exercise Program |
| Core Exercise + Action Observation | Experimental | Participants receive the same core exercise therapy plus an action observation session before each treatment. Receives: Other: Action Observation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
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".
Measured: Baseline (Day 1) and After 6 Weeks of Treatment
Secondary outcomes (4)
Functionality Level
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.
Measured: Baseline (Day 1) and Week 6.
Core Muscle Endurance
Trunk Flexor Test - Trunk Extensor Test -Side Bridge Test - Prone plank Test
Measured: At baseline and after 6 weeks of intervention
Kinesiofobia Level
"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).
Measured: Baseline and Week 6.
Sleep Quality
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.
Measured: From the start of treatment until 6 week after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion16 Jan 2026 (estimated)
- Study completion16 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Hamdi Mohamed Kamal Shalabi, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237724
- Sponsor's protocol ID
- 61351342/020-65
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy considerations and restrictions imposed by the ethics committee
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.
PubMed 32147444Ozturk 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.
PubMed 33582621Salik 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.
PubMed 34487008
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery on Pain, Function, Endurance, Kinesiophobia and Sleep Quality in Patients With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07237724
- Acronym / sponsor ID
- 61351342/020-65
- Conditions
- Non-specific Low Back Pain
- Keywords
- action observation, Non-specific Low Back Pain, core exercises
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 16 Jan 2026 (estimated)
- Study completion
- 16 Jan 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Exercise Program | Active comparator | Other: Core Exercise ProgramParticipants receive supervised core exercise therapy 3 times per week for 6 weeks. |
| Core Exercise + Action Observation | Experimental | Other: Action Observation TherapyParticipants receive the same core exercise therapy plus an action observation session before each treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core Exercise Program* The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist * patients will receive core exercises program, 3 days per week * Treatment duration is 6 weeks | Other | Core Exercise Program |
| Action Observation Therapy* The patients will do their exercises at the clinic as face to face sessions. All sessions will be conducted under the supervision of a physiotherapist * patients will receive the same core exercises program as the Active comparator group, 3 days per week for 6 weeks * This group will receive action observation therapy for 6 minutes before every exercise therapy session. they will watch videos of 2 different activates, the duration of each video is 3 minutes and will be recorded from 3 planes (front, back and lateral ) | Other | Core Exercise + Action Observation |
Primary outcome
Pain Level
Time frame: Baseline (Day 1) and After 6 Weeks of Treatment
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".
4 secondary outcomes
Functionality Level
Time frame: Baseline (Day 1) and Week 6.
Core Muscle Endurance
Time frame: At baseline and after 6 weeks of intervention
Kinesiofobia Level
Time frame: Baseline and Week 6.
Sleep Quality
Time frame: From the start of treatment until 6 week after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 32147444Salik 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.
- Results publication: PubMed 33582621Ozturk 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.
- Results publication: PubMed 34487008Salik 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy considerations and restrictions imposed by the ethics committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Exercise Program and Action Observation Therapy in people with Non-specific Low Back Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level (time frame: Baseline (Day 1) and After 6 Weeks of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.