- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359144
Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women
The Effect of Pilates Exercises on Nonspecific Low Back Pain in Postnatal Women
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman M Elsheikh, MBBCH
- Phone Number: 00201009094244
- Email: emanelshiekh858@gmail.com
Study Locations
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
- Recruiting
- Kafrelsheikh University (Faculty of Physical Therapy)
-
Sub-Investigator:
- Fayiz F Elshamy, MD
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Sub-Investigator:
- Muhammad F AbdulGalil, MD
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Sub-Investigator:
- Mostafa F Ellakany, MD
-
Contact:
- Eman M Elsheikh, MBBCH
- Phone Number: 00201009094244
- Email: emanelshiekh858@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A) (Study group):
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.
|
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.
|
|
Active Comparator: Group (B) (Control group)
Patients will perform a home-based exercise program consisting solely of postural correction exercises.
|
Patients will perform a home-based exercise program consisting solely of postural correction exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of pain pressure threshold
Time Frame: 3 months post-procedure
|
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.
|
3 months post-procedure
|
|
Assessment of functional disability
Time Frame: 3 months post-procedure
|
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.
|
3 months post-procedure
|
|
Assessment of the quality of life
Time Frame: 3 months post-procedure
|
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.
|
3 months post-procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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