NCT06262763

Brief Summary

Effect of high intensity laser on sacroiliac joint pain

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

January 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

February 6, 2024

Last Update Submit

February 14, 2024

Conditions

Sacroiliac Joint Pain

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    By Visual Analogue Sclae (VAS)

    At the beginning and at after 12 session (1 month)

Secondary Outcomes (1)

  • Pressure pain threshold

    At the beginning and at after 12 session (1 month)

Other Outcomes (1)

  • Functional disability

    At the beginning and at after 12 session (1 month)

Study Arms (2)

Group (A)

EXPERIMENTAL

Laser with traditional exercises

Device: Laser TherapyOther: Traditional exercises

Group (B)

PLACEBO COMPARATOR

Placebo LASER with traditional exercises

Other: Traditional exercisesOther: Placebo laser

Interventions

Laser TherapyDEVICE

High-intensity

Also known as: High power
Group (A)
Traditional exercisesOTHER

Hamstring and piriformis stretch, plank exercises and bird dog exercise

Group (A)Group (B)
Placebo laserOTHER

Not directed radiation to participant

Group (B)

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The presence of Pain over the sacroiliac joint with no surgical history.
  • Unmarried.
  • Tender SIJ on palpation.
  • Workers with an average age of 18-30 years.
  • Body mass index did not exceed 30 kg/m2.

You may not qualify if:

  • If they have Infections. .Fracture in and around the SIJ Complex.
  • Arthritis of joint.
  • Pregnancy. .Smoking girls. .Patient not willing to participate in the study. .Any history of surgery. Lumbar spine disc herniation or back injury. Tumor around the joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr Al-Sheikh University

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

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
Principle investigator

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 16, 2024

Study Start

January 3, 2023

Primary Completion

April 28, 2023

Study Completion

March 28, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

EG(1)