NCT06141954

Brief Summary

This study will be conducted to compare between effect of therapeutic ultrasound and low-level laser therapy on sacroiliac joint pain after delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

November 9, 2023

Last Update Submit

August 22, 2024

Conditions

Keywords

Ultrasound therapyLow level laser therapy

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale (VAS)

    This scale will be used by each patient before and after treatment course to estimate the intensity of pain. Visual analogue scale (VAS) is a graphic rating scale with numerical values ranging from 0 to 4, placed equidistantly on a line of 10 cm long drawn horizontally.

    4 weeks

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

Effect of ultrasound therapy on sacroiliac joint pain in woman postpartum

Device: Ultrasound waves therapy

Low level laser

ACTIVE COMPARATOR

Effect of low level laser therapy on sacroiliac joint pain in woman postpartum

Device: Low level laser therapy

Interventions

Therapeutic ultrasound is proposed to deliver energy to deep tissue sites through ultrasonic waves, to produce increases in tissue temperature or non- thermal physiologic changes. Low level laser therapy penetrates particularly light waves that increase cellular metabolism.

Ultrasound

Low-level laser (light) therapy (LLLT) is a fast-growing technology used to treat a multitude of conditions that require stimulation of healing, relief of pain and inflammation, and restoration of function.

Low level laser

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssacroiliac pain in woman postpartum
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • sacroiliac joint dysfunction
  • severe pain in the sacroiliac joint
  • Age will range from 25 to 35 years old.
  • Body Mass Index: ≤30 kg/m2
  • The type of delivery is a cesarean section.
  • All patients will not receive any medical treatment to relieve pain or decrease inflammation.
  • All patients are not pregnant.

You may not qualify if:

  • Diabetic mellitus and hypertension
  • Cardiovascular diseases
  • heart diseases
  • Rheumatoid arthritis
  • Cervical spondylosis with radiculopathy or any spinal diseases
  • (5) leukemia. (6) Deformities in their hands (7) Burns, ulcers, open wounds, or any skin diseases in dominant hands (8) received medications or have been injected with steroids at a tender point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadat General Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Fiani B, Sekhon M, Doan T, Bowers B, Covarrubias C, Barthelmass M, De Stefano F, Kondilis A. Sacroiliac Joint and Pelvic Dysfunction Due to Symphysiolysis in Postpartum Women. Cureus. 2021 Oct 9;13(10):e18619. doi: 10.7759/cureus.18619. eCollection 2021 Oct.

    PMID: 34786225BACKGROUND

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison between effect of ultrasound and low level laser on sacroiliac joint pain in woman postpartum
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapy practitioner

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 21, 2023

Study Start

December 1, 2023

Primary Completion

January 30, 2024

Study Completion

June 30, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations