Low Back PainNCT06156163
Effectiveness of Perturbation Training in Nonspecific Low Back Pain
A study testing Perturbation training and Exercise in people with Low Back Pain, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Perturbation training and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2023to 10 Dec 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nonspecific low back pain persisting for at least 3 months
- Pain intensity at least 3 on VAS
- Ability to perceive verbal and written Turkish instructions
- Having signed the voluntary consent form
Who cannot join
- History of spinal surgery/trauma
- Low back cpain associated with other pathologies (Rheumatic diseases, malignancy, MS)
- Having herniation at the level of sequestration and extrusion
- Instability conditions such as spondylolysis and spondylolisthesis
- Use of painkillers and antidepressants
- Pregnancy
Show all 9Show fewer
- Obesity (BMI≥30kg/m²)
- Orthopedic problems and chronic diseases that may prevent exercises
- FTR/steroid injection application within the last 3 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
About this study
Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low back pain. Spinal stabilization exercises, which are among the therapeutic exercises, aim to improve and improve muscle control to compensate for any loss of muscle movement caused by degenerative changes or injury. Perturbation training, which is among the neuromuscular exercises, is an intervention that aims to improve the control of rapid balance reactions and involves repetitive postural distortions. In perturbation training, the surface is moved in multiple directions with different forces and moments. The aim of this exercise is to develop the stabilization response that will be created by stresses applied from different directions. It is believed that the number of motor units participating in contraction and proprioceptive input will increase with perturbation exercise. Although the number of studies on low back pain is quite limited, it has been stated that applications that provide perturbation can reduce the incidence of low back pain and provide improvement in neuromuscular control of spinal stability. In the light of these data, the aim of this study is to investigate the effects of perturbation training given in addition to the exercise program on trunk muscle endurance, pain, disability, functionality, fear avoidance beliefs and quality of life parameters in individuals with nonspecific low back pain.
Read the detailed description
Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low back pain. In current guidelines, it has been reported that patient education and therapeutic exercises are treatment methods with a high level of evidence. Spinal stabilization exercises, which are among the therapeutic exercises, aim to improve and improve muscle control to compensate for any loss of muscle movement caused by degenerative changes or injury. With stabilization exercises, deep muscles are activated while excessive activity of superficial muscles is reduced. Thus, correcting muscle abnormalities and ensuring the correct function of the muscles supports the spine. Perturbation training, which is among the neuromuscular exercises, is an intervention that aims to improve the control of rapid balance reactions and involves repetitive postural distortions. In perturbation training, the surface is moved in multiple directions with different forces and moments. The aim of this exercise is to develop the stabilization response that will be created by stresses applied from different directions. It is believed that the number of motor units participating in contraction and proprioceptive input will increase with perturbation exercise. Previous studies have shown that the effects of perturbation training were mostly investigated in geriatric and neurological patient groups. However, current studies show that perturbation training is also applied to some orthopedic problems such as anterior cruciate ligament injury, shoulder pain, ankle instability and makes positive contributions to the healing process.
Although the number of studies on low back pain is quite limited, it has been stated that applications that provide perturbation can reduce the incidence of low back pain and provide improvement in neuromuscular control of spinal stability. In the light of these data, the aim of this study is to investigate the effects of perturbation training given in addition to the exercise program on trunk muscle endurance, pain, disability, functionality, fear avoidance beliefs and quality of life parameters in individuals with nonspecific low back pain.
- Conditions
- Low Back Pain
- Being tested
- Perturbation training, Exercise
- Keywords
- low back pain, nonspecific low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation trainingOther
The exercise program will be applied 2 days/week for 8 weeks, with the addition of progressive perturbation conditions.
ExerciseOther
The exercise program will be applied 2 days/week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation Group | Experimental | Exercise program with progressive perturbation conditions Receives: Other: Perturbation training |
| Exercise Group | Active comparator | Exercise program Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk extensor endurance test
Individuals are asked to hang their trunks from the bed starting from the spina iliaca anterior superior and cross both arms on the shoulders. The legs are fixed by the practitioner over the gastrocnemius muscle. The test is started when the individuals maintain the horizontal position and the time they maintain the position is recorded in seconds.
Measured: At baseline and after 8 weeks of intervention
Trunk flexor endurance test
The participant is positioned by the tester with the knees and hips at 90 degrees, the body at 60 degrees, the hands in a crossed position on both shoulders, and the soles of the feet firmly on the ground. The time this position can be maintained is recorded in seconds.
Measured: At baseline and after 8 weeks of intervention
Bilater side bridge endurance test
For the left lateral plank test, the participants' feet are placed on top of each other, the right arm is perpendicular to the ground, the elbow is on the mat, the left arm is at chest level, and the left hand is on the right shoulder. When the individual is ready, he is asked to lift his hips with support from his elbows and feet. As soon as the test position is taken in which the shoulders, hips and feet are in the same direction, the time is started by the researcher. The period ends when the individual cannot maintain the position and body swings forward and backward.
Measured: At baseline and after 8 weeks of intervention
Secondary outcomes (6)
Pain intensity
The pain felt by the participants at rest, during activity and at night will be questioned with the "0-10 cm" Visual Analogue Scale (VAS). On VAS, 0 means "no pain" and 10 means "worst pain ever felt".
Measured: At baseline and after 8 weeks of intervention
Disability
The disability levels of the participants will be evaluated with the 'Oswestry Disability Index (ODS)'. The survey contains 10 questions on 10 topics with 6 options. The increase in the total score is proportional to the increase in activity limitation.
Measured: At baseline and after 8 weeks of intervention
Timed Up and Go Test
The 3-meter area in front of the chair is determined. The patient is asked to get up from the chair, walk this distance and sit down again. The elapsed time gives the result of the test and the time is recorded in seconds. The test is performed twice with a 1-minute interval and the average time is taken.
Measured: At baseline and after 8 weeks of intervention
The Fear-Avoidance Beliefs Questionnaire (FABQ)
The Fear-Avoidance Beliefs Questionnaire (FABQ) is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability.
The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. [2] There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24).
Measured: At baseline and after 8 weeks of intervention
Health-related quality-of-life
Individuals' health-related quality of life will be evaluated with Short Form-12/SF-12. With SF-12, two subscores are obtained: physical component summary (PBS) and mental component summary (MBS). While the FBÖ-12 score is obtained from the sub-dimensions of general health, physical functionality, physical role and body pain, the MBÖ-12 score is obtained from the social functionality, emotional role, mental health and energy sub-dimensions. Both FBÖ-12 and MBÖ-12 scores range from 0 to 100, with a higher score representing better health.
Measured: At baseline and after 8 weeks of intervention
Patient Satisfaction
Patient satisfaction with the treatment will be evaluated with the Global Rating of Change scale. Participants will be asked to rate their condition compared to baseline after an 8-week intervention period, indicating whether they had significantly improved, slightly improved, remained unchanged, slightly deteriorated, or significantly worsened in this study.
Measured: After 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start16 Dec 2023
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Akgüller, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156163
- Sponsor's protocol ID
- takguller
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2023
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
PubMed 34719942Fitzgerald GK, Axe MJ, Snyder-Mackler L. The efficacy of perturbation training in nonoperative anterior cruciate ligament rehabilitation programs for physical active individuals. Phys Ther. 2000 Feb;80(2):128-40.
PubMed 10654060Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7.
PubMed 30630753Schafer R, Schafer H, Platen P. Perturbation-based trunk stabilization training in elite rowers: A pilot study. PLoS One. 2022 May 19;17(5):e0268699. doi: 10.1371/journal.pone.0268699. eCollection 2022.
PubMed 35587490Arampatzis A, Schroll A, Catala MM, Laube G, Schuler S, Dreinhofer K. A random-perturbation therapy in chronic non-specific low-back pain patients: a randomised controlled trial. Eur J Appl Physiol. 2017 Dec;117(12):2547-2560. doi: 10.1007/s00421-017-3742-6. Epub 2017 Oct 19.
PubMed 29052033Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
PubMed 17141568Shamsi MB, Rezaei M, Zamanlou M, Sadeghi M, Pourahmadi MR. Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial. Physiother Theory Pract. 2016;32(3):171-8. doi: 10.3109/09593985.2015.1117550. Epub 2016 Feb 11.
PubMed 26864057
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perturbation Training in Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06156163
- Acronym / sponsor ID
- takguller
- Conditions
- Low Back Pain
- Keywords
- low back pain, nonspecific low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 5 Dec 2023 (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.
Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low back pain. Spinal stabilization exercises, which are among the therapeutic exercises, aim to improve and improve muscle control to compensate for any loss of muscle movement caused by degenerative changes or injury. Perturbation training, which is among the neuromuscular exercises, is an intervention that aims to improve the control of rapid balance reactions and involves repetitive postural distortions. In perturbation training, the surface is moved in multiple directions with different forces and moments. The aim of this exercise is to develop the stabilization response that will be created by stresses applied from different directions. It is believed that the number of motor units participating in contraction and proprioceptive input will increase with perturbation exercise. Although the number of studies on low back pain is quite limited, it has been stated that applications that provide perturbation can reduce the incidence of low back pain and provide improvement in neuromuscular control of spinal stability. In the light of these data, the aim of this study is to investigate the effects of perturbation training given in addition to the exercise program on trunk muscle endurance, pain, disability, functionality, fear avoidance beliefs and quality of life parameters in individuals with nonspecific low back pain.
Detailed description
Nonspecific low back pain is defined as low back pain that cannot be associated with a specific identified pathology. Many methods such as patient education, medical treatment, physical modalities, exercise, manual therapy, massage, traction and cognitive behavioral therapy are used in the treatment of nonspecific low back pain. In current guidelines, it has been reported that patient education and therapeutic exercises are treatment methods with a high level of evidence. Spinal stabilization exercises, which are among the therapeutic exercises, aim to improve and improve muscle control to compensate for any loss of muscle movement caused by degenerative changes or injury. With stabilization exercises, deep muscles are activated while excessive activity of superficial muscles is reduced. Thus, correcting muscle abnormalities and ensuring the correct function of the muscles supports the spine. Perturbation training, which is among the neuromuscular exercises, is an intervention that aims to improve the control of rapid balance reactions and involves repetitive postural distortions. In perturbation training, the surface is moved in multiple directions with different forces and moments. The aim of this exercise is to develop the stabilization response that will be created by stresses applied from different directions. It is believed that the number of motor units participating in contraction and proprioceptive input will increase with perturbation exercise. Previous studies have shown that the effects of perturbation training were mostly investigated in geriatric and neurological patient groups. However, current studies show that perturbation training is also applied to some orthopedic problems such as anterior cruciate ligament injury, shoulder pain, ankle instability and makes positive contributions to the healing process.
Although the number of studies on low back pain is quite limited, it has been stated that applications that provide perturbation can reduce the incidence of low back pain and provide improvement in neuromuscular control of spinal stability. In the light of these data, the aim of this study is to investigate the effects of perturbation training given in addition to the exercise program on trunk muscle endurance, pain, disability, functionality, fear avoidance beliefs and quality of life parameters in individuals with nonspecific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation Group | Experimental | Other: Perturbation trainingExercise program with progressive perturbation conditions |
| Exercise Group | Active comparator | Other: ExerciseExercise program |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nonspecific low back pain persisting for at least 3 months
- Pain intensity at least 3 on VAS
- Ability to perceive verbal and written Turkish instructions
- Having signed the voluntary consent form
Key exclusion criteria (9 listed)
- History of spinal surgery/trauma
- Low back cpain associated with other pathologies (Rheumatic diseases, malignancy, MS)
- Having herniation at the level of sequestration and extrusion
- Instability conditions such as spondylolysis and spondylolisthesis
- Use of painkillers and antidepressants
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 |
|---|---|---|
| Perturbation trainingThe exercise program will be applied 2 days/week for 8 weeks, with the addition of progressive perturbation conditions. | Other | Perturbation Group |
| ExerciseThe exercise program will be applied 2 days/week for 8 weeks. | Other | Exercise Group |
Primary outcome
Trunk extensor endurance test
Time frame: At baseline and after 8 weeks of intervention
Individuals are asked to hang their trunks from the bed starting from the spina iliaca anterior superior and cross both arms on the shoulders. The legs are fixed by the practitioner over the gastrocnemius muscle. The test is started when the individuals maintain the horizontal position and the time they maintain the position is recorded in seconds.
Trunk flexor endurance test
Time frame: At baseline and after 8 weeks of intervention
The participant is positioned by the tester with the knees and hips at 90 degrees, the body at 60 degrees, the hands in a crossed position on both shoulders, and the soles of the feet firmly on the ground. The time this position can be maintained is recorded in seconds.
Bilater side bridge endurance test
Time frame: At baseline and after 8 weeks of intervention
For the left lateral plank test, the participants' feet are placed on top of each other, the right arm is perpendicular to the ground, the elbow is on the mat, the left arm is at chest level, and the left hand is on the right shoulder. When the individual is ready, he is asked to lift his hips with support from his elbows and feet. As soon as the test position is taken in which the shoulders, hips and feet are in the same direction, the time is started by the researcher. The period ends when the individual cannot maintain the position and body swings forward and backward.
6 secondary outcomes
Pain intensity
Time frame: At baseline and after 8 weeks of intervention
Disability
Time frame: At baseline and after 8 weeks of intervention
Timed Up and Go Test
Time frame: At baseline and after 8 weeks of intervention
The Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: At baseline and after 8 weeks of intervention
Health-related quality-of-life
Time frame: At baseline and after 8 weeks of intervention
Patient Satisfaction
Time frame: After 8 weeks of intervention
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 31 Dec 2024.
- Background: PubMed 34719942George SZ, Fritz JM, Silfies SP, Schneider MJ, Beneciuk JM, Lentz TA, Gilliam JR, Hendren S, Norman KS. Interventions for the Management of Acute and Chronic Low Back Pain: Revision 2021. J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. doi: 10.2519/jospt.2021.0304.
- Background: PubMed 10654060Fitzgerald GK, Axe MJ, Snyder-Mackler L. The efficacy of perturbation training in nonoperative anterior cruciate ligament rehabilitation programs for physical active individuals. Phys Ther. 2000 Feb;80(2):128-40.
- Background: PubMed 30630753Schinkel-Ivy A, Huntley AH, Aqui A, Mansfield A. Does Perturbation-Based Balance Training Improve Control of Reactive Stepping in Individuals with Chronic Stroke? J Stroke Cerebrovasc Dis. 2019 Apr;28(4):935-943. doi: 10.1016/j.jstrokecerebrovasdis.2018.12.011. Epub 2019 Jan 7.
- Background: PubMed 35587490Schafer R, Schafer H, Platen P. Perturbation-based trunk stabilization training in elite rowers: A pilot study. PLoS One. 2022 May 19;17(5):e0268699. doi: 10.1371/journal.pone.0268699. eCollection 2022.
- Background: PubMed 29052033Arampatzis A, Schroll A, Catala MM, Laube G, Schuler S, Dreinhofer K. A random-perturbation therapy in chronic non-specific low-back pain patients: a randomised controlled trial. Eur J Appl Physiol. 2017 Dec;117(12):2547-2560. doi: 10.1007/s00421-017-3742-6. Epub 2017 Oct 19.
- Background: PubMed 17141568Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
- Background: PubMed 26864057Shamsi MB, Rezaei M, Zamanlou M, Sadeghi M, Pourahmadi MR. Does core stability exercise improve lumbopelvic stability (through endurance tests) more than general exercise in chronic low back pain? A quasi-randomized controlled trial. Physiother Theory Pract. 2016;32(3):171-8. doi: 10.3109/09593985.2015.1117550. Epub 2016 Feb 11.
- Individual participant dataSharing planned: No
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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.
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 Perturbation training and Exercise in people with Low Back Pain, run by Istanbul Arel 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 4 inclusion and 9 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 31 Dec 2024. 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?
Trunk extensor endurance test (time frame: At baseline and after 8 weeks of intervention). The study lists 3 primary outcomes in all. 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 NCT06156163, which also lists 7 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 31 Dec 2024.