Low Back PainNCT05529719
Effects of 12-Week Clinical Pilates Exercises on Mechanical Low Back Pain
A study testing Clinical Pilates Exercises in people with Low Back Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain. Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Clinical Pilates Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2020to 31 Jul 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 30 years of age; who had suffered from low back pain for at least three months; who had not used medication for low back pain in the last three months; who did not have a surgical history due to spinal problems; who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; who had not received any treatment related to low back within the last six months; who had not previously continued pilates exercise; and who had sufficient physical autonomy to participate in the physical activities required by the study.
Who cannot join
- Volunteers who did not meet the inclusion criteria were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 12-Week Clinical Pilates Exercises in Young Adults With Mechanical Low Back Pain a Randomized Controlled Study
Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.
Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.
Cases: A total of 63 mechanical low back pain volunteers were included. Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).
Read the detailed description
Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.
Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.
Cases: A total of 63 mechanical low back pain volunteers were included. The diagnosis of mechanical low back pain was made by a physical medicine and rehabilitation physician. Exercises are performed by an experienced physiotherapist with Clinical Pilates certification.
Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).
Leading measures: Dysfunction was evaluated with the Oswestry Dysfunction Index. The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Low bak pain was evaluated with the Visual Analog Scale (VAS). VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. And flexibility was evaluated with the sit and reach test test. The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles. Measurements were performed at baseline and the end of the 12th week of the study.
- Conditions
- Low Back Pain
- Being tested
- Clinical Pilates Exercises
- Keywords
- Clinical Pilates, Low back pain, Therapeutic Exercise
- 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.
Clinical Pilates ExercisesOther
Participants in the experimental group were included in the clinical Pilates intervention, which consisted of three weekly sessions for 50 minutes for 12 weeks. Clinical pilates sessions were performed by a clinically Pilates-certified instructor and a physiotherapist. The intervention was divided into three sections. Each session started with the warm-up section. The warm-up part started with breathing exercises, pelvic tilt centering, activation of deep trunk and pelvic floor muscles, and joint mobility. The Clinical Pilates exercises section consisted of matte level strength and flexibility exercises involving the trunk, upper and lower extremities. Finally, a cooling part was done that included some flexibility exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Patients assigned to the control group were given theoretical training and a brochure containing MBA information. The control group patients participating in the evaluation session were recommended to be included in the same clinical Pilates training conducted by the intervention group after the study was completed. Receives: Other: Clinical Pilates Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prim Outcome - Oswestry Dysability Index
Pain-related functional competence was evaluated with the Oswestry disability index (ODI). ODI is a questionnaire consisting of 10 questions measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleep, travel status, and cognitive status of pain. Each question is evaluated between 0-5 points, and the ratio of the received score to the total answered question score gives the patient score. It is known that functional competence decreases and disability increases as the total score increases. It is interpreted as 0% to 20% - minimum disability 20% to 40% - moderate disability; 40% to 60% - severe disability; 60% to 80% - disabled 80% to 100% - bed-bound (or exaggerated symptoms).
Measured: 12 weeks
Secondary outcomes (1)
Sec Outcome - Visual Analogue Scale
Visual analog scale (VAS) scores were recorded to inquire about the pain status from the participants' registration information. In VAS, which is a horizontal line ten centimeters long, 0 indicates that there is no pain, while 10 indicates the most severe pain. Studies showed that VAS scores for those with chronic musculoskeletal pain corresponded to mild pain, 3.5 to 7.4 corresponded to moderate pain, and 7.5corresponds to severe pain.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start3 Jul 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a randomized controlled trial. Participants were randomly assigned to the intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emir İbrahim IŞIK, Cukurova University
- Investigators
- Erkan KOZANOGLU, Professor, Study chair, Cukurova University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529719
- Sponsor's protocol ID
- Cp12wMlb
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) of this study available to other researchers.
Publications
Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.
PubMed 24994051Stoll J. THE LUMBAR SPINE: Mechanical Diagnosis and Therapy, R.A. Orthopedics. 1982 Oct;5(10):1378-82. doi: 10.3928/0147-7447-19821001-15. No abstract available.
PubMed 24830644Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.
PubMed 25395111van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the cochrane collaboration back review group. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2784-96. doi: 10.1097/00007632-200011010-00011.
PubMed 11064524Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004 Jan;35(1):57-64. doi: 10.1016/S0030-5898(03)00088-9.
PubMed 15062718Natour J, Cazotti Lde A, Ribeiro LH, Baptista AS, Jones A. Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2015 Jan;29(1):59-68. doi: 10.1177/0269215514538981. Epub 2014 Jun 25.
PubMed 24965957
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 12-Week Clinical Pilates Exercises in Young Adults With Mechanical Low Back Pain a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05529719
- Acronym / sponsor ID
- Cp12wMlb
- Conditions
- Low Back Pain
- Keywords
- Clinical Pilates, Low back pain, Therapeutic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 7 Sep 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.
Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.
Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.
Cases: A total of 63 mechanical low back pain volunteers were included. Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).
Detailed description
Objective: This study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain.
Design: This is a randomized controlled trial. Setting: This study was conducted in a university's physiotherapy and exercise practice laboratory.
Cases: A total of 63 mechanical low back pain volunteers were included. The diagnosis of mechanical low back pain was made by a physical medicine and rehabilitation physician. Exercises are performed by an experienced physiotherapist with Clinical Pilates certification.
Interventions: Participants were randomly assigned to the intervention group consisting of clinical Pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).
Leading measures: Dysfunction was evaluated with the Oswestry Dysfunction Index. The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. Low bak pain was evaluated with the Visual Analog Scale (VAS). VAS is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. And flexibility was evaluated with the sit and reach test test. The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles. Measurements were performed at baseline and the end of the 12th week of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a randomized controlled trial. Participants were randomly assigned to the intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Clinical Pilates ExercisesPatients assigned to the control group were given theoretical training and a brochure containing MBA information. The control group patients participating in the evaluation session were recommended to be included in the same clinical Pilates training conducted by the intervention group after the study was completed. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 to 30 years of age; who had suffered from low back pain for at least three months; who had not used medication for low back pain in the last three months; who did not have a surgical history due to spinal problems; who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; who had not received any treatment related to low back within the last six months; who had not previously continued pilates exercise; and who had sufficient physical autonomy to participate in the physical activities required by the study.
Key exclusion criteria (1 listed)
- Volunteers who did not meet the inclusion criteria were excluded.
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 |
|---|---|---|
| Clinical Pilates ExercisesParticipants in the experimental group were included in the clinical Pilates intervention, which consisted of three weekly sessions for 50 minutes for 12 weeks. Clinical pilates sessions were performed by a clinically Pilates-certified instructor and a physiotherapist. The intervention was divided into three sections. Each session started with the warm-up section. The warm-up part started with breathing exercises, pelvic tilt centering, activation of deep trunk and pelvic floor muscles, and joint mobility. The Clinical Pilates exercises section consisted of matte level strength and flexibility exercises involving the trunk, upper and lower extremities. Finally, a cooling part was done that included some flexibility exercises. | Other | Control group |
Primary outcome
Prim Outcome - Oswestry Dysability Index
Time frame: 12 weeks
Pain-related functional competence was evaluated with the Oswestry disability index (ODI). ODI is a questionnaire consisting of 10 questions measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleep, travel status, and cognitive status of pain. Each question is evaluated between 0-5 points, and the ratio of the received score to the total answered question score gives the patient score. It is known that functional competence decreases and disability increases as the total score increases. It is interpreted as 0% to 20% - minimum disability 20% to 40% - moderate disability; 40% to 60% - severe disability; 60% to 80% - disabled 80% to 100% - bed-bound (or exaggerated symptoms).
1 secondary outcome
Sec Outcome - Visual Analogue Scale
Time frame: 12 weeks
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 7 Sep 2022.
- Background: PubMed 24994051Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.
- Background: PubMed 24830644Stoll J. THE LUMBAR SPINE: Mechanical Diagnosis and Therapy, R.A. Orthopedics. 1982 Oct;5(10):1378-82. doi: 10.3928/0147-7447-19821001-15. No abstract available.
- Background: PubMed 25395111Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.
- Background: PubMed 11064524van Tulder M, Malmivaara A, Esmail R, Koes B. Exercise therapy for low back pain: a systematic review within the framework of the cochrane collaboration back review group. Spine (Phila Pa 1976). 2000 Nov 1;25(21):2784-96. doi: 10.1097/00007632-200011010-00011.
- Background: PubMed 15062718Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004 Jan;35(1):57-64. doi: 10.1016/S0030-5898(03)00088-9.
- Background: PubMed 24965957Natour J, Cazotti Lde A, Ribeiro LH, Baptista AS, Jones A. Pilates improves pain, function and quality of life in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2015 Jan;29(1):59-68. doi: 10.1177/0269215514538981. Epub 2014 Jun 25.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) of this study available to other researchers.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Erkan KOZANOGLU, Professor study chair
Cukurova University, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pilates Exercises in people with Low Back Pain, run by Cukurova 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 1 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 7 Sep 2022. 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?
Prim Outcome - Oswestry Dysability Index (time frame: 12 weeks). 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 NCT05529719, which also lists 6 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 7 Sep 2022.