Subacute Low Back PainPilates-SLBPNCT06699511
Effectiveness of Pilates in Patients With Subacute Low Back Pain
A study testing Exercise in people with Subacute Low Back Pain, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Low Back Pain
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Dec 2024
- 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
- Adults aged between 18 and 65 years.D
- Diagnosis of subacute low back pain, defined as pain lasting between 6 and 12 weeks
- No previous Pilates experience.
Who cannot join
- History of spinal surgery or significant spinal deformities (e.g., scoliosis).
- Presence of serious medical conditions such as cardiovascular disease, uncontrolled hypertension, or neurological disorders.
- Pregnancy or planned pregnancy during the study period.
- Use of pain-relief medications that could interfere with the results of the study.
- Participation in any structured physical therapy program in the last three months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Beykent Univesity
Istanbul, Büyükçekmece, 34500
About this study
This study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Pilates is an exercise method that strengthens core muscle groups, improves flexibility, and supports body balance.
This research is designed as a comparative study between two groups. One group will participate in Pilates exercises, while the other group will follow a standard home exercise program. The study will assess outcomes such as pain level, mobility, and quality of life. Through this, the study aims to provide more insights into the potential of Pilates as a treatment method for subacute low back pain.
Read the detailed description
This study investigates the role of Pilates exercises in managing subacute low back pain, a condition defined as lasting between 4 and 12 weeks. Subacute low back pain often disrupts daily functioning and lowers quality of life, and effective interventions during this stage are crucial to prevent the transition to chronic pain. Pilates has been suggested as a beneficial exercise approach due to its focus on core stability, flexibility, and balanced body mechanics, which may reduce pain and improve functional outcomes in low back pain patients.
Participants in the study will be divided into two groups: a Pilates group and a home exercise group. The Pilates group will participate in a structured Pilates program designed to target core muscle strength and flexibility over a set period, while the home exercise group will follow a standard exercise program tailored for general low back pain relief. Both groups will perform their respective exercises for eight weeks.
The primary outcome measures will include pain intensity, physical function, and quality of life, assessed at baseline, post-treatment, and follow-up periods. The findings from this study will contribute to understanding whether Pilates can be a valuable addition to conservative treatment approaches for subacute low back pain.
- Conditions
- Subacute Low Back Pain
- Being tested
- Exercise
- Keywords
- Pilates, Subacute low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise
| Study group | Role | What they receive |
|---|---|---|
| pilates exercise | Active comparator | pilates exercise Receives: Behavioral: Exercise |
| Home exercis | Active comparator | Home exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The Visual Analog Scale (VAS) is used to measure pain intensity. The scale ranges from 0 to 10, where 0 represents 'no pain' and 10 represents 'worst possible pain.' Higher scores indicate worse outcomes, signifying greater pain intensity
Measured: pretreatment, post-treatment (8 weeks), and at 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2024 (estimated)
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 Subacute 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
- This study utilizes a parallel-group interventional study model to compare the effects of Pilates exercises versus a standard home exercise program on subacute low back pain. Participants are randomly assigned to one of two groups: Pilates Group: Participants in this group will receive a structured Pilates program targeting core stability, flexibility, and posture correction, which is specifically designed for low back pain management. Pilates exercises will be supervised by a qualified instructor to ensure proper technique and safety. Home Exercise Group: Participants in this group will follow a standard home exercise regimen tailored to relieve low back pain. These exercises focus on general strength and flexibility but are not specific to Pilates techniques. Both groups will participate in their respective programs for eight weeks. Outcomes, including pain levels, functional mobility, and quality of life, will be measured at three time points: baseline, post-treatment, and follow
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TUĞBA ŞAHBAZ, University of Beykent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699511
- Sponsor's protocol ID
- KAEK/2022.11.211
- Other IDs
- KAEK/2022.11.211
- Acronym
- Pilates-SLBP
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share IPD is currently under consideration and will depend on future funding resources and availability of data-sharing infrastructure.
Publications
Asik HK, Sahbaz T. Preventing chronic low back pain: investigating the role of Pilates in subacute management-a randomized controlled trial. Ir J Med Sci. 2025 Jun;194(3):949-956. doi: 10.1007/s11845-025-03939-y. Epub 2025 Apr 4.
PubMed 40183915
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pilates in Patients With Subacute Low Back Pain
- ClinicalTrials.gov ID
- NCT06699511
- Acronym / sponsor ID
- Pilates-SLBP / KAEK/2022.11.211
- Conditions
- Subacute Low Back Pain
- Keywords
- Pilates, Subacute low back pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Nov 2024 (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 study aims to evaluate the effectiveness of Pilates exercises in patients with subacute low back pain, which typically lasts between 4 and 12 weeks. Subacute low back pain is longer-lasting than acute pain and can negatively impact daily activities and quality of life. Pilates is an exercise method that strengthens core muscle groups, improves flexibility, and supports body balance.
This research is designed as a comparative study between two groups. One group will participate in Pilates exercises, while the other group will follow a standard home exercise program. The study will assess outcomes such as pain level, mobility, and quality of life. Through this, the study aims to provide more insights into the potential of Pilates as a treatment method for subacute low back pain.
Detailed description
This study investigates the role of Pilates exercises in managing subacute low back pain, a condition defined as lasting between 4 and 12 weeks. Subacute low back pain often disrupts daily functioning and lowers quality of life, and effective interventions during this stage are crucial to prevent the transition to chronic pain. Pilates has been suggested as a beneficial exercise approach due to its focus on core stability, flexibility, and balanced body mechanics, which may reduce pain and improve functional outcomes in low back pain patients.
Participants in the study will be divided into two groups: a Pilates group and a home exercise group. The Pilates group will participate in a structured Pilates program designed to target core muscle strength and flexibility over a set period, while the home exercise group will follow a standard exercise program tailored for general low back pain relief. Both groups will perform their respective exercises for eight weeks.
The primary outcome measures will include pain intensity, physical function, and quality of life, assessed at baseline, post-treatment, and follow-up periods. The findings from this study will contribute to understanding whether Pilates can be a valuable addition to conservative treatment approaches for subacute low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study utilizes a parallel-group interventional study model to compare the effects of Pilates exercises versus a standard home exercise program on subacute low back pain. Participants are randomly assigned to one of two groups: Pilates Group: Participants in this group will receive a structured Pilates program targeting core stability, flexibility, and posture correction, which is specifically designed for low back pain management. Pilates exercises will be supervised by a qualified instructor to ensure proper technique and safety. Home Exercise Group: Participants in this group will follow a standard home exercise regimen tailored to relieve low back pain. These exercises focus on general strength and flexibility but are not specific to Pilates techniques. Both groups will participate in their respective programs for eight weeks. Outcomes, including pain levels, functional mobility, and quality of life, will be measured at three time points: baseline, post-treatment, and follow
| Arm | Type | Receives |
|---|---|---|
| pilates exercise | Active comparator | Behavioral: Exercisepilates exercise |
| Home exercis | Active comparator | Behavioral: ExerciseHome exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged between 18 and 65 years.D
- Diagnosis of subacute low back pain, defined as pain lasting between 6 and 12 weeks
- No previous Pilates experience.
Key exclusion criteria (5 listed)
- History of spinal surgery or significant spinal deformities (e.g., scoliosis).
- Presence of serious medical conditions such as cardiovascular disease, uncontrolled hypertension, or neurological disorders.
- Pregnancy or planned pregnancy during the study period.
- Use of pain-relief medications that could interfere with the results of the study.
- Participation in any structured physical therapy program in the last three months.
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 |
|---|---|---|
| ExerciseExercise | Behavioural | Home exercis, pilates exercise |
Primary outcome
Visual Analog Scale
Time frame: pretreatment, post-treatment (8 weeks), and at 3-month follow-up
The Visual Analog Scale (VAS) is used to measure pain intensity. The scale ranges from 0 to 10, where 0 represents 'no pain' and 10 represents 'worst possible pain.' Higher scores indicate worse outcomes, signifying greater pain intensity
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 21 Nov 2024.
- Derived from this study: PubMed 40183915Asik HK, Sahbaz T. Preventing chronic low back pain: investigating the role of Pilates in subacute management-a randomized controlled trial. Ir J Med Sci. 2025 Jun;194(3):949-956. doi: 10.1007/s11845-025-03939-y. Epub 2025 Apr 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision to share IPD is currently under consideration and will depend on future funding resources and availability of data-sharing infrastructure.
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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 Exercise in people with Subacute Low Back Pain, run by University of Beykent 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 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?
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?
Visual Analog Scale (time frame: pretreatment, post-treatment (8 weeks), and at 3-month follow-up). 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 NCT06699511, 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 21 Nov 2024.