NCT07359144

Brief Summary

This study aims to investigate the effects of Pilates for postnatal women with Non-specific low back pain (NSLBP).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 14, 2026

Last Update Submit

January 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    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 Outcomes (3)

  • Assessment of pain pressure threshold

    3 months post-procedure

  • Assessment of functional disability

    3 months post-procedure

  • Assessment of the quality of life

    3 months post-procedure

Study Arms (2)

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.

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.

Other: Home exercise program

Interventions

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.

Group (A) (Study group):

Patients will perform a home-based exercise program consisting solely of postural correction exercises.

Group (B) (Control group)

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostnatal Women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University (Faculty of Physical Therapy)

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Eman M Elsheikh, MBBCH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy, Misr University for Science and Technology (2018)

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

January 22, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations