Low Back PainNCT05433311
The Effect of Exercise on Motion Perception and Fear in Low Back Pain
A study testing Exercises in people with Low Back Pain, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily accepting the study
- Having nonspecific low back pain for 3 months or longer
- Not having had spinal surgery in the last 6 months
- Not having an orthopedic or neurological disability that would prevent them from doing their exercises
- Patients who regularly continue their exercises without interrupting
Who cannot join
- Patients with non-specific low back pain who do not meet the inclusion criteria and want to drop out of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise Program on Perception of Exercise and Fear of Movement in Nonspecific Low Back Pain
Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Contrary to what is known, this cycle aggravates pain. With this result, it is suggested that the exercise to be done will improve the perception of benefit in the person and eliminate the fear of movement, and that it will cure the disease. In this context, the aim of the study is to examine the effect of exercise on the perception of exercise and fear of movement in patients with NLBP.
Read the detailed description
The study will be composed of volunteers, non-specific low back pain individuals who meet the inclusion criteria. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, trunk flexibility measurements) will be recorded by the physiotherapist in the evaluation form. In addition to these measurements, the state of fear of physical movement and activity will be evaluated with the Tampa Kinesiophobia Scale.
- Conditions
- Low Back Pain
- Being tested
- Exercises
- Keywords
- nonspesific low back pain, flexibility, kinesiphobia, pain
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Exercises | Active comparator | Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises Receives: Other: Exercises |
| Routine | No intervention | Only routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Benefit/Barrier Scale
This scale is a 4 scores Likert-type. Scale consisting 43 questions. A high score means exercise perception. When Benefit Scale is evaluated on its own, how high the total score of 29 items is it means that exercise perception is beneficial in high level. In Barrier Scale which consists 14 items, the higher obtained total score is, higher the barrier level perceived against exercise is.
Measured: Change in participate in life ine one month
Secondary outcomes (1)
Tampa Scale of Kinesiophobia
Tampa Scale of Kinesiophobia is a checklist of 17 questions. 4-point Likert scale on the scale rating (1= strongly disagree, 4= I totally agree). Person between 17-68 total gets a score. The score of the person on the scale high, kinesiophobia is also high. shows. Total score in studies use is recommended.
Measured: Change in participate in life ine one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start6 Sep 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- Patients included in the treatment group had 15 sessions. Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises will be done face-to-face with a physiotherapist. At the end of the 15 sessions of face-to-face training the patients will be perform the same exercises at home for 15 days. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in the both groups will be made three that pre-treatment, post-treatment, 15 days after the end of treatment.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine ARGALI DENIZ, Suleyman Demirel University
- Investigators
- Mine ARGALI DENIZ, PT, PhD, Study director, Suleyman Demirel University Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433311
- Sponsor's protocol ID
- 72867572-050.01.04-95550
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Argali Deniz M, Ozuberk B, Soyupek F. The effect of exercise program on exercise perception and fear of movement in low back pain. Eur Spine J. 2026 May;35(5):2934-2944. doi: 10.1007/s00586-025-09720-0. Epub 2026 Jan 9.
PubMed 41507620
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Program on Perception of Exercise and Fear of Movement in Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT05433311
- Acronym / sponsor ID
- 72867572-050.01.04-95550
- Conditions
- Low Back Pain
- Keywords
- nonspesific low back pain, flexibility, kinesiphobia, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 27 Jun 2022 (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.
Nonspesific low back pain (NLBP), which negatively affects functionality, activity participation, and financial situation, is now one of the leading causes of disability in the world. In NLBP, pain causes kinesiophobia known as fear of movement and limitation of activity. Contrary to what is known, this cycle aggravates pain. With this result, it is suggested that the exercise to be done will improve the perception of benefit in the person and eliminate the fear of movement, and that it will cure the disease. In this context, the aim of the study is to examine the effect of exercise on the perception of exercise and fear of movement in patients with NLBP.
Detailed description
The study will be composed of volunteers, non-specific low back pain individuals who meet the inclusion criteria. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, trunk flexibility measurements) will be recorded by the physiotherapist in the evaluation form. In addition to these measurements, the state of fear of physical movement and activity will be evaluated with the Tampa Kinesiophobia Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients included in the treatment group had 15 sessions. Neutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises will be done face-to-face with a physiotherapist. At the end of the 15 sessions of face-to-face training the patients will be perform the same exercises at home for 15 days. The patients will not given any exercises in the control group. Measurements and evaluations of the patients in the both groups will be made three that pre-treatment, post-treatment, 15 days after the end of treatment.
| Arm | Type | Receives |
|---|---|---|
| Exercises | Active comparator | Other: ExercisesNeutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises |
| Routine | No intervention | –Only routine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily accepting the study
- Having nonspecific low back pain for 3 months or longer
- Not having had spinal surgery in the last 6 months
- Not having an orthopedic or neurological disability that would prevent them from doing their exercises
- Patients who regularly continue their exercises without interrupting
Key exclusion criteria (1 listed)
- Patients with non-specific low back pain who do not meet the inclusion criteria and want to drop out of the study
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 |
|---|---|---|
| ExercisesNeutral position training, transversus abdominis/multifidius/abdominal/back extensors strengthening exercise, bridge exercise, cat-camel exercise, lumbal extensor/hamstring/gastrosoleus/latissimus dorsi/gluteal stretching exercises | Other | Exercises |
Primary outcome
Exercise Benefit/Barrier Scale
Time frame: Change in participate in life ine one month
This scale is a 4 scores Likert-type. Scale consisting 43 questions. A high score means exercise perception. When Benefit Scale is evaluated on its own, how high the total score of 29 items is it means that exercise perception is beneficial in high level. In Barrier Scale which consists 14 items, the higher obtained total score is, higher the barrier level perceived against exercise is.
1 secondary outcome
Tampa Scale of Kinesiophobia
Time frame: Change in participate in life ine one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 41507620Argali Deniz M, Ozuberk B, Soyupek F. The effect of exercise program on exercise perception and fear of movement in low back pain. Eur Spine J. 2026 May;35(5):2934-2944. doi: 10.1007/s00586-025-09720-0. Epub 2026 Jan 9.
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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. This study is not recruiting at the moment.
Mine ARGALI DENIZ, PT, PhD study director
Suleyman Demirel University Education and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Low Back Pain, run by Suleyman Demirel 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise Benefit/Barrier Scale (time frame: Change in participate in life ine one month). 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 NCT05433311, which also lists 1 linked publication.
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 19 Oct 2026.