Chronic Non-Specific Low Back PainNCT07839052
The Effect of Core Stabilization Exercises on Balance in Older Adults With Low Back Pain
A study testing Core stabilisation exercises + usual physiotherapy care and Usual physiotherapy care + general exercise programme in people with Chronic Non-Specific Low Back Pain, run by University of West Attica at 1 site in Greece.
Trial summary
This research aims to investigate the effect of a core stabilization exercise programme, combined with usual physiotherapy care, on balance in older adults, aged over 65 years with chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Non-Specific Low Back Pain
- What is being tested?
- Core stabilisation exercises + usual physiotherapy care and Usual physiotherapy care + general exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 25 Oct 2026to 25 Oct 2029
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old or older.
- They have to be diagnosed with chronic non-specific low back pain lasting for at least 3 months.
- Low back pain intensity greater than 3/10 on the Visual Analog Scale (VAS).
- Functional independence.
- They have to be able to walk independently without assistive devices.
- Adequate cognitive function and ability to understand and follow instructions.
- Ability and willingness to provide written consent.
Who cannot join
- Severe spinal disorders, including spinal stenosis with neurological deficits, recent vertebral fracture or spondylolisthesis.
- Spinal surgery within the last 12 months.
- Acute low back pain, lasting less than 6 weeks.
- Neurological disorders affecting balance or postural control, including Parkinson's disease or stroke.
- Vestibular disorders that may significantly affect balance.
- Severe visual impairment or diagnosed cognitive impairment.
Show all 9Show fewer
- Malignancy.
- Musculoskeletal or cardiopulmonary conditions at a level that affects and contraindicates exercise.
- If they use regurarly hig-dose analgesic medication, specifically for the management of the symptoms of low 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.
Greece1 site
KINAISTHISI Physiotherapy Clinic Address: Pandora 2, Galatsi, 11146, Greece
Athens, Galatsi, 11146
About this study
This research aims to investigate the effect of a core stabilization exercise programme, combined with usual physiotherapy care, on balance in older adults, aged over 65 years with chronic non-specific low back pain. Participants will be randomly allocated to either an intervention group, receiving the core stabilization exercise programme additional to usual physiotherapy care, or a control group receiving usual physiotherapy care, combined with a general mobility and strengthening exercise programme. Participants will be assessed at baseline, after 12 weeks (3 months), and at a 6-month follow-up.
Read the detailed description
This study will investigate the effect of a progressive core stabilisation programme combined with usual physiotherapy care on balance in older adults with chronic non-specific low back pain. Participants will be randomly allocated to one of two groups.
The intervention group will receive a core stabilisation programme in combination with usual physiotherapy care. The exercise programme will focus on activation, motor control and strength of trunk muscles, and the exercises will be performed in supine, prone, quadruped, sitting, and standing positions.
The control group will receive usual physiotherapy care and an additional general exercise programme, that will include mobility, strengthening, stretching and low-to-moderate walking exercises.
Participants will undergo assessments at three points. Specifically at baseline (T0), after completion of the 12 week intervention (T1), and at 6 months after the completion of intervention (T2). The assessments will be performed by an independent assessor, blinded to group allocation, in order to minimize assessment bias.
- Conditions
- Chronic Non-Specific Low Back Pain
- Being tested
- Core stabilisation exercises + usual physiotherapy care, Usual physiotherapy care + general exercise programme
- Keywords
- core stability, core stability exercises, aging adults, older adults, balance, balance exercises, risk of falls, usual physiotherapy care, 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.
Core stabilisation exercises + usual physiotherapy careOther
The core stabilization exercise programme will include activation, motor control and strengthening exercises targeting the deep and superficial trunk muscles. The programme will consist of exercises such as abdominal drawing-in maneuver, camel-cat exercise, bird dog, dead bug, bridges, modified front and side planks. The intervention will be individually progressed according to functional capacity and exercise tolerance. The duration of the exercise programme per session will be approximately 20-25 minutes, additional to approximately 5 minutes of warm-up and 5 minutes of cool-down.
The usual physiotherapy care will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice relevant to the maintenance of physical activity. This component of the intervention will be the same for both groups.
Usual physiotherapy care + general exercise programmeOther
Participants will receive usual physiotherapy care including interventions commonly used for the management of chronic low back pain. These will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice regarding physical activity. This component of the intervention will be the same for both groups.
To ensure comparable overall treatment duration between groups, participants will perform approximately 20 minutes of general mobility and strengthening exercises for the spine and upper and lower limb, as well as stretching exercises, additional to moderate intensity walking exercises. This exercise programme will not include specific core stabilisation exercises or balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Core stabilisation exercises + usual physiotherapy care group | Experimental | Participants will receive a progressive core stabilization exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour. Receives: Other: Core stabilisation exercises + usual physiotherapy care |
| Usual Physiotherapy care + General exercise programme group | Active comparator | Participants will receive a general exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour. Receives: Other: Usual physiotherapy care + general exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale (BBS) is a 14-item standardized clinical assessment tool used to evaluate functional balance in older adults. It assesses static and dynamic balance during functional activities, including transfers, standing balance, turning, and single-leg stance. Each item is scored from 0 to 4, with a higher total score indicating better balance performance.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Secondary outcomes (6)
Timed Up and Go
The Timed Up and Go test is used to assess functional mobility and dynamic balance. The participant has the instruction to stand up from the chair, walk 3 meters, turn, return to the chair and sit down. The total time needed to complete the task is recorded.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Single Leg Stance test
The Single Leg Stance test is used to assess static postural balance. The duration of the participant's ability to maintain a single leg stance withoout external support wll be recorded.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Sit to Stand test
The Sit-to-Stand test will be used for the assessment of the functional lower limb strength and dynamic balance. Participants will perform a repeated sit to stand task. The time required to complete the task will be recorded.
Measured: Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)
Oswestry Disability Index
The Oswestry Disability Index is a subjective outcome measure used to assess functional disability associated with low back pain. The outcome is expressed as a percentage, with higher scores indicating greater disability.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
SF-36 Health Survey
The SF-36 Health Survey is a subjective, patient-reported, measure of health, related to the quality of life, that includes multiple subscales of physical and mental health.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Stabilizer Pressure Biofeedback
Trunk stabilization performance will be assessed with a Stabilizer Pressure Biofeedback device. The procedure will include two standardized tests.
In the first test, the device will be positioned beneath the participant's abdomen in the prone position at an initial pressure of 70 mmHg. The participant will perform an abdominal drawing in maneuver, in purpose to reduce the pressure by 10 mmHg and to maintain this position for as long as possible.
In the second test, the device will be positioned beneath the lumbar spine in the supine position at an initial pressure of 40 mmHg. The participant will perform a posterior pelvic tilt, aiming to increase the pressure by 10 mmHg and to maintain this position for as long as possible.
For both test, the duration for which the participant is able to maintain the target peressure will be recorded.
Measured: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start25 Oct 2026 (estimated)
- Primary completion25 Jul 2029 (estimated)
- Study completion25 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koutsampela Eva, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839052
- Sponsor's protocol ID
- 64954
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Exercises on Balance in Older Adults With Low Back Pain
- ClinicalTrials.gov ID
- NCT07839052
- Acronym / sponsor ID
- 64954
- Conditions
- Chronic Non-Specific Low Back Pain
- Keywords
- core stability, core stability exercises, aging adults, older adults, balance, balance exercises, risk of falls, usual physiotherapy care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 25 Jul 2029 (estimated)
- Study completion
- 25 Oct 2029 (estimated)
- First posted
- 24 Sep 2026 (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.
This research aims to investigate the effect of a core stabilization exercise programme, combined with usual physiotherapy care, on balance in older adults, aged over 65 years with chronic non-specific low back pain. Participants will be randomly allocated to either an intervention group, receiving the core stabilization exercise programme additional to usual physiotherapy care, or a control group receiving usual physiotherapy care, combined with a general mobility and strengthening exercise programme. Participants will be assessed at baseline, after 12 weeks (3 months), and at a 6-month follow-up.
Detailed description
This study will investigate the effect of a progressive core stabilisation programme combined with usual physiotherapy care on balance in older adults with chronic non-specific low back pain. Participants will be randomly allocated to one of two groups.
The intervention group will receive a core stabilisation programme in combination with usual physiotherapy care. The exercise programme will focus on activation, motor control and strength of trunk muscles, and the exercises will be performed in supine, prone, quadruped, sitting, and standing positions.
The control group will receive usual physiotherapy care and an additional general exercise programme, that will include mobility, strengthening, stretching and low-to-moderate walking exercises.
Participants will undergo assessments at three points. Specifically at baseline (T0), after completion of the 12 week intervention (T1), and at 6 months after the completion of intervention (T2). The assessments will be performed by an independent assessor, blinded to group allocation, in order to minimize assessment bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stabilisation exercises + usual physiotherapy care group | Experimental | Other: Core stabilisation exercises + usual physiotherapy careParticipants will receive a progressive core stabilization exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour. |
| Usual Physiotherapy care + General exercise programme group | Active comparator | Other: Usual physiotherapy care + general exercise programmeParticipants will receive a general exercise programme combined with usual physiotherapy care. The intervention will be delivered twice per week for 12 weeks. Each intervention session will last approximately one hour. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65 years old or older.
- They have to be diagnosed with chronic non-specific low back pain lasting for at least 3 months.
- Low back pain intensity greater than 3/10 on the Visual Analog Scale (VAS).
- Functional independence.
- They have to be able to walk independently without assistive devices.
Key exclusion criteria (9 listed)
- Severe spinal disorders, including spinal stenosis with neurological deficits, recent vertebral fracture or spondylolisthesis.
- Spinal surgery within the last 12 months.
- Acute low back pain, lasting less than 6 weeks.
- Neurological disorders affecting balance or postural control, including Parkinson's disease or stroke.
- Vestibular disorders that may significantly affect balance.
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 stabilisation exercises + usual physiotherapy careThe core stabilization exercise programme will include activation, motor control and strengthening exercises targeting the deep and superficial trunk muscles. The programme will consist of exercises such as abdominal drawing-in maneuver, camel-cat exercise, bird dog, dead bug, bridges, modified front and side planks. The intervention will be individually progressed according to functional capacity and exercise tolerance. The duration of the exercise programme per session will be approximately 20-25 minutes, additional to approximately 5 minutes of warm-up and 5 minutes of cool-down. The usual physiotherapy care will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice relevant to the maintenance of physical activity. This component of the intervention will be the same for both groups. | Other | Core stabilisation exercises + usual physiotherapy care group |
| Usual physiotherapy care + general exercise programmeParticipants will receive usual physiotherapy care including interventions commonly used for the management of chronic low back pain. These will include joint and soft-tissue mobilisation, myofascial release techniques, superficial heat, low-frequency TENS, postural education, ergonomic advice and advice regarding physical activity. This component of the intervention will be the same for both groups. To ensure comparable overall treatment duration between groups, participants will perform approximately 20 minutes of general mobility and strengthening exercises for the spine and upper and lower limb, as well as stretching exercises, additional to moderate intensity walking exercises. This exercise programme will not include specific core stabilisation exercises or balance exercises. | Other | Usual Physiotherapy care + General exercise programme group |
Primary outcome
Berg Balance Scale
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
The Berg Balance Scale (BBS) is a 14-item standardized clinical assessment tool used to evaluate functional balance in older adults. It assesses static and dynamic balance during functional activities, including transfers, standing balance, turning, and single-leg stance. Each item is scored from 0 to 4, with a higher total score indicating better balance performance.
6 secondary outcomes
Timed Up and Go
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Single Leg Stance test
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Sit to Stand test
Time frame: Baseline (T0), 12 weeks (T1), additional assessment at 6 months (T2)
Oswestry Disability Index
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
SF-36 Health Survey
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
Stabilizer Pressure Biofeedback
Time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)
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 29 Sep 2026.
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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.
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 stabilisation exercises + usual physiotherapy care and Usual physiotherapy care + general exercise programme in people with Chronic Non-Specific Low Back Pain, run by University of West Attica at 1 site in Greece.
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 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: opening soon, as of the sponsor's last update on 29 Sep 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 Greece. 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?
Contact EVA KOUTSAMPELA, PhD Canditate (+306984872699, ekoutsampela@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline (T0) to 12 weeks (T1), additional assessment at 6 months (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.