Low Back PainRCTNCT04135131
Efficacyof Pilates Exercises in Lowback Pain
A study testing pilates mat exercises and home exercises in people with Low Back Pain and Physical Therapy, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
OBJECTIVE: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Low Back Pain, Physical Therapy, Pilates
- What is being tested?
- pilates mat exercises and home exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 1 Jan 2019
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- chronic non-specific low back pain for >3 months,
- visual analog scale (VAS) score of 3-6
- female patients aged 18-60 years,
- body mass index (BMI) within normal limits (18.5-24.9 kg/m²)
- ability to continue the program.
Who cannot join
- Malignancies,
- infections
- inflammatory diseases
- severe osteoporosis,
- arthritis
- metabolic bone diseases
Show all 11Show fewer
- pregnancy
- cardiovascular diseases that limit effort capacity
- other musculoskeletal conditions that may impede attaining positions required in exercises
- a history of spinal surgery
- cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Education and Research Hospital
Istanbul
About this study
Official title: Comparison of The Efficacy of Pilates Exercises and Home Exercise Program on Pain, Functional Level and Thickness of Core Muscles in Patients With Low Back Pain
OBJECTIVE: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with home based exercise.
MATERIAL AND METHODS: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.
Read the detailed description
A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.
- Conditions
- Low Back Pain, Physical Therapy, Pilates
- Being tested
- pilates mat exercises and home exercises
- Keywords
- Abdominal Muscles, Exercise Therapy, Low back pain, Paraspinal Muscles
- 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.
pilates mat exercises and home exercisesOther
Patients with low back pain were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. Pilates mat exercise program comprised three sessions a week for 8 weeks (Monday, Wednesday, and Friday), with each session being scheduled for 1 h (5-min warm-up, 50-min exercise, and 5-min cooling) and each set comprising 10 repetitions. The home exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises.
| Study group | Role | What they receive |
|---|---|---|
| PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN | Experimental | Patients were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. The evaluations were made at the beginning and end of the treatment. Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests. Multifidus and abdominal muscle thickness were measured by ultrasound image Receives: Other: pilates mat exercises and home exercises |
| HOME EXERCISE | Placebo comparator | The exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises. Patients were asked to perform three sets of exercises (10 repetitions) for three times a week for 8 weeks. Exercise training was provided by a physiotherapist. Patients were also provided an illustrated exercise brochure along with an exercise diary to record the number of days on which exercise was performed. They were followed up by phone calls every 2 weeks Receives: Other: pilates mat exercises and home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOGUE SCALE (VAS) for pain
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
Measured: 6 months
The Oswestry Disability Index
lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability.
Measured: 6 months
The Quebec Back Pain Disability Scale
low back pain The minimum score is 20 and the maximum score is 100. Higher scores correlate to greater disability.
Measured: 6 months
Short Form-36
(quality of life) questionnaire that covers eight health domains;Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: 6 months
Beck Depression Questionnaire
depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
Measured: 6 months
Sit and reach test
flexibility
Measured: 6 months
Modified Schöber and sit up tests
flexibility and endurance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized-single blinded study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135131
- Sponsor's protocol ID
- HNEAH-KAEK 2017/kk/19
- Acronym
- RCT
- Status last verified
- Oct 2019
- First submitted
- 29 Sep 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Efficacy of Pilates Exercises and Home Exercise Program on Pain, Functional Level and Thickness of Core Muscles in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04135131
- Acronym / sponsor ID
- RCT / HNEAH-KAEK 2017/kk/19
- Conditions
- Low Back Pain, Physical Therapy, Pilates
- Keywords
- Abdominal Muscles, Exercise Therapy, Low back pain, Paraspinal Muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 22 Oct 2019 (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: To investigate the effects of pilates exercise by training the muscles responsible for core stabilization in patients with chronic non-specific low back pain (CNLPB); considering pain, functional level, depression, quality of life, and muscle thickness measured by Ultrasound Imaging and to compare it with home based exercise.
MATERIAL AND METHODS: A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.
Detailed description
A prospective, randomized-single blinded study included 60 female patients with CNLBP aged 18-60 years. Patients were randomized into 2 groups. The first group (n=30) performed pilates 3 days/week for 8 weeks. Sessions lasted about one hour and supervised by a pilates trainer. The second group (n=30) was given home exercise program 3 times/week for 8 weeks, each session lasting one hour. The evaluations were made both at the beginning and end of the treatment. Evaluation parameters included VAS (visual analogue scale), Oswestry Disability Index, Qubec Disability Scale, Short Form-36 (SF-36), Beck Depression Questionnaire, sit and reach test, Modified Schöber test, sit up test. Multifidus and abdominal muscle thickness were measured by Ultrasonographic Imaging.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized-single blinded study
| Arm | Type | Receives |
|---|---|---|
| PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN | Experimental | Other: pilates mat exercises and home exercisesPatients were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. The evaluations were made at the beginning and end of the treatment. Outcome parameters were VAS, Oswestry Disability Index, Qubec Disability Scale, Short Form-36, Beck Depression Questionnaire, sit and reach, Modified Schöber and sit up tests. Multifidus and abdominal muscle thickness were measured by ultrasound image |
| HOME EXERCISE | Placebo comparator | Other: pilates mat exercises and home exercisesThe exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises. Patients were asked to perform three sets of exercises (10 repetitions) for three times a week for 8 weeks. Exercise training was provided by a physiotherapist. Patients were also provided an illustrated exercise brochure along with an exercise diary to record the number of days on which exercise was performed. They were followed up by phone calls every 2 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- chronic non-specific low back pain for >3 months,
- visual analog scale (VAS) score of 3-6
- female patients aged 18-60 years,
- body mass index (BMI) within normal limits (18.5-24.9 kg/m²)
- ability to continue the program.
Key exclusion criteria (11 listed)
- Malignancies,
- infections
- inflammatory diseases
- severe osteoporosis,
- arthritis
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 |
|---|---|---|
| pilates mat exercises and home exercisesPatients with low back pain were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. Pilates mat exercise program comprised three sessions a week for 8 weeks (Monday, Wednesday, and Friday), with each session being scheduled for 1 h (5-min warm-up, 50-min exercise, and 5-min cooling) and each set comprising 10 repetitions. The home exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises. | Other | HOME EXERCISE, PILATES MAT EXERCISE EFFECT ON LOW BACK PAIN |
Primary outcome
VISUAL ANALOGUE SCALE (VAS) for pain
Time frame: 6 months
pain (min-max:0-10) Higher scores correlate to higher intensity of pain
The Oswestry Disability Index
Time frame: 6 months
lowback functional disability The minimum score is 0% and the maximum score is 100%. Higher scores correlate to greater disability.
The Quebec Back Pain Disability Scale
Time frame: 6 months
low back pain The minimum score is 20 and the maximum score is 100. Higher scores correlate to greater disability.
Short Form-36
Time frame: 6 months
(quality of life) questionnaire that covers eight health domains;Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Beck Depression Questionnaire
Time frame: 6 months
depression The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.
Sit and reach test
Time frame: 6 months
flexibility
Modified Schöber and sit up tests
Time frame: 6 months
flexibility and endurance
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 24 Oct 2019.
- Individual participant dataSharing planned: No
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.
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 pilates mat exercises and home exercises in people with Low Back Pain and Physical Therapy, run by Haydarpasa Numune Training and Research Hospital 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 11 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 24 Oct 2019. 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. Some participants in this study may receive a placebo. 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?
VISUAL ANALOGUE SCALE (VAS) for pain (time frame: 6 months). The study lists 7 primary outcomes in all. 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 24 Oct 2019.