Pilates ExercisesNCT07359144
Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women
A study testing Pilates program + Home exercise program and Home exercise program in people with Pilates Exercises and Nonspecific, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to investigate the effects of Pilates for postnatal women with Non-specific low back pain (NSLBP). Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Pilates Exercises, Nonspecific, Low Back Pain
- What is being tested?
- Pilates program + Home exercise program and Home exercise program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2026to 1 Jul 2026
- 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 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ranges from 20 and 30 years old.
- Body mass index (BMI) doesn't exceed 30 kg/m2.
- Patients who are referred from a gynecologist with a diagnosis of nonspecific low back pain.
- Patients who have pain for more than three months.
- Patients who have parity ranging from one to three (to control the extreme physiological changes from multiple childbirths, ensuring a more uniform sample).
- Patients who have score more than 4 on the Visual Analog Scale (VAS).
Who cannot join
- Mechanical low back pain (LBP).
- Women who had performed any spinal surgery e.g. unilateral hemilaminectomy or microdiscectomy.
- Women with history of vertebral fracture or trauma.
- Women with systemic disorder e.g. diabetes mellitus.
- Women who are pregnant.
- Women who had received physiotherapy treatment for their LBP one month before the start of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University (Faculty of Physical Therapy)
Kafr ash Shaykh, Kafrelsheikh, 33516
Eman M Elsheikh, MBBCH, 00201009094244, emanelshiekh858@gmail.com
Fayiz F Elshamy, MD
About this study
Official title: The Effect of Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women
This study aims to investigate the effects of Pilates for postnatal women with Non-specific low back pain (NSLBP).
Read the detailed description
Low back pain (LBP) is of high prevalence among adults, which can be related to factors such as sedentary lifestyle, being overweight or work conditions.
Non-specific LBP (NSLBP) is defined as pain in the lower back region that cannot be attributed to a recognizable, specific pathology such as infection, fracture, or nerve root compression.
Pilates exercises focus on improving core stability, flexibility, posture, and body awareness through controlled, precise movements. The integration of breathing techniques and concentration enhances the mind-body connection, which can contribute to pain reduction and functional improvement. For individuals with LBP, Pilates has been shown to improve strength and flexibility, reduce pain intensity, and enhance overall physical function, making it a promising intervention for managing musculoskeletal disorders.
- Conditions
- Pilates Exercises, Nonspecific, Low Back Pain, Postnatal Women
- Being tested
- Pilates program + Home exercise program, Home exercise program
- 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 program + Home exercise programOther
Patients will do a comprehensive exercise consisting of a home exercise program (bridges, bridge with leg extension (bridge dog), back extensions, spine twist, and child's pose), a Pilates program, and oral paracetamol as needed for pain relief.
Home exercise programOther
Patients will perform a home-based exercise program consisting solely of postural correction exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) (Study group): | Experimental | Patients will do a comprehensive exercise consisting of a home exercise program (bridges, bridge with leg extension (bridge dog), back extensions, spine twist, and child's pose), a Pilates program, and oral paracetamol as needed for pain relief. Receives: Other: Pilates program + Home exercise program |
| Group (B) (Control group) | Active comparator | Patients will perform a home-based exercise program consisting solely of postural correction exercises. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain Intensity will be assessed using Visual Analog Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 3 months post-procedure
Secondary outcomes (3)
Assessment of pain pressure threshold
Pain pressure threshold (PPT) will be determined using a handheld electronic pressure algometer with a 1 cm2 probe area with an increasing of the pressure rate of 20 Kpa/s. The pressure algometer consists of a "pistol" handle and a rod with a pressure-sensitive gauge strain at the tip.
Measured: 3 months post-procedure
Assessment of functional disability
Oswestry Disability Index will be used to assess functional disability. It is a self-assessing questionnaire for low back pain, which includes 10 items; each contains six levels of answers ranging from 0-5. Its items include pain intensity, personal care, lifting objects, walking, sitting, standing, sleeping, sex life, social life, and travelling. A total score is calculated, divided by 50, and multiplied by 100. It ranges from 0% indicating no disability to 100% indicating complete disability.
Measured: 3 months post-procedure
Assessment of the quality of life
Quality of life (QOL) will be assessed using SF-36 Questionnaire. SF-36 questionnaire consists of thirty-six questions measuring PH components (physical function, role physic, bodily pain, general health and MH components (vitality, social functioning, role emotion, general mental health). The response for each item was scored from 0-100, and the mean score of each domain was calculated. Lower score implied poor QoL, whereas higher score indicated excellent QoL.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start22 Jan 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilates ExercisesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mosbah Mohamed Elsheikh, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359144
- Sponsor's protocol ID
- KFSIRB200-686
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women
- ClinicalTrials.gov ID
- NCT07359144
- Acronym / sponsor ID
- KFSIRB200-686
- Conditions
- Pilates Exercises, Nonspecific, Low Back Pain, Postnatal Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 22 Jan 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 study aims to investigate the effects of Pilates for postnatal women with Non-specific low back pain (NSLBP).
Detailed description
Low back pain (LBP) is of high prevalence among adults, which can be related to factors such as sedentary lifestyle, being overweight or work conditions.
Non-specific LBP (NSLBP) is defined as pain in the lower back region that cannot be attributed to a recognizable, specific pathology such as infection, fracture, or nerve root compression.
Pilates exercises focus on improving core stability, flexibility, posture, and body awareness through controlled, precise movements. The integration of breathing techniques and concentration enhances the mind-body connection, which can contribute to pain reduction and functional improvement. For individuals with LBP, Pilates has been shown to improve strength and flexibility, reduce pain intensity, and enhance overall physical function, making it a promising intervention for managing musculoskeletal disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) (Study group): | Experimental | Other: Pilates program + Home exercise programPatients will do a comprehensive exercise consisting of a home exercise program (bridges, bridge with leg extension (bridge dog), back extensions, spine twist, and child's pose), a Pilates program, and oral paracetamol as needed for pain relief. |
| Group (B) (Control group) | Active comparator | Other: Home exercise programPatients will perform a home-based exercise program consisting solely of postural correction exercises. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age ranges from 20 and 30 years old.
- Body mass index (BMI) doesn't exceed 30 kg/m2.
- Patients who are referred from a gynecologist with a diagnosis of nonspecific low back pain.
- Patients who have pain for more than three months.
- Patients who have parity ranging from one to three (to control the extreme physiological changes from multiple childbirths, ensuring a more uniform sample).
Key exclusion criteria (6 listed)
- Mechanical low back pain (LBP).
- Women who had performed any spinal surgery e.g. unilateral hemilaminectomy or microdiscectomy.
- Women with history of vertebral fracture or trauma.
- Women with systemic disorder e.g. diabetes mellitus.
- Women who are pregnant.
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 program + Home exercise programPatients will do a comprehensive exercise consisting of a home exercise program (bridges, bridge with leg extension (bridge dog), back extensions, spine twist, and child's pose), a Pilates program, and oral paracetamol as needed for pain relief. | Other | Group (A) (Study group): |
| Home exercise programPatients will perform a home-based exercise program consisting solely of postural correction exercises. | Other | Group (B) (Control group) |
Primary outcome
Pain Intensity
Time frame: 3 months post-procedure
Pain Intensity will be assessed using Visual Analog Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
3 secondary outcomes
Assessment of pain pressure threshold
Time frame: 3 months post-procedure
Assessment of functional disability
Time frame: 3 months post-procedure
Assessment of the quality of life
Time frame: 3 months post-procedure
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 23 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Pilates program + Home exercise program and Home exercise program in people with Pilates Exercises and Nonspecific, run by Kafrelsheikh University at 1 site in Egypt.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Jan 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 Egypt. 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 Eman M Elsheikh, MBBCH (00201009094244, emanelshiekh858@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 3 months post-procedure). 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 23 Jan 2026.