NCT06785363

Brief Summary

The iliolumbar ligament, one of the sacroiliac ligaments, has been identified in recent research as a contributor to low back pain when tight. During pregnancy, hormonal changes and postural changes can cause this ligament to tighten, leading to pain. Releasing the iliolumbar ligament can reduce low back pain and restore normal mechanical function.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 15, 2025

Last Update Submit

January 28, 2025

Conditions

Keywords

low back painlumbar and sacroiliac painiliolumbar ligament disorder

Outcome Measures

Primary Outcomes (3)

  • Visual analog scale (VAS):

    It will be used to assess the severity of low back pain in women from both groups A and B before and after treatment. The scoring ranges from 1, indicating the least pain and discomfort, to 10, representing the most severe pain and discomfort.

    8 weeks

  • Goniometer

    It will be used to assess lumbar flexion range of motion for each woman in both groups A and B before and after treatment.

    8 weeks

  • Inclinometer

    It will be used to assess lumbar curvature for each woman in both groups A and B before and after treatment.

    8 weeks

Study Arms (2)

Pumped technique for iliolumbar ligament release

EXPERIMENTAL
Other: pumped technique for ilio-lumbar ligament release

Hot packs

ACTIVE COMPARATOR

postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks.

Other: Hot Packs

Interventions

Patient position: the patient lying supine or side lying Therapist position: standing on one side of patient. Hand grip: one hand placed on posterior region of iliac crest (close to attachment of ilio-lumbar ligament) while other hand stabilize the medial part of thigh. Therapist force: therapist pulling patient's thigh posteriorly.

Pumped technique for iliolumbar ligament release

postnatal women will be treated by hot packs for 20 minutes three times per week for 8 weeks.

Hot packs

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the women are delivery within 3 months. 3- Their BMI must be less than 30 Kg\\m 2 . 4- Its included primipara or multipara. 5- Its included be normal vaginal labor delivery or caesarian section.

You may not qualify if:

  • Clinical diagnosis by Lumbar disc prolapse.
  • Clinical diagnosis by Lumbar spondylolysis and spondlysis.
  • Clinical diagnosis by back trauma or fracture.
  • Clinical diagnosis by Lumbar canal stenosis.
  • Clinical diagnosis by Rheumatoid arthritis.
  • Clinical diagnosis by Malignancy.
  • Clinical diagnosis by any deformity for low limb.
  • Clinical diagnosis by Scoliosis.
  • Taking analgesic drugs.
  • Clinical diagnosis by Deep vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher assistance in Faculty of physical therapy, Pharos University in Alexandria

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 21, 2025

Study Start

October 1, 2024

Primary Completion

April 30, 2025

Study Completion

May 15, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations