High-intensity Laser Therapy for Sacroiliac Joint Pain | NCT06262763

Studies
High-intensity Laser Therapy for Sacroiliac Joint Pain

NCT06262763

Sponsor

Kafrelsheikh University

Status

Unknown status

Last Update Posted

Feb 16, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Sacroiliac Joint Pain

Interventions

Laser Therapy
Traditional exercises
Placebo laser

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2023Actual

Primary Completion Date

Apr 28, 2023Actual

Completion Date

Mar 28, 2024Estimated

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 14, 2024

First Posted Date

Feb 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2024

Last Update Posted Date

Feb 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Takwa Mohamed Saied Gado, Principle investigator, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Effect of high intensity laser on sacroiliac joint pain

Detailed Description

Effect of high laser in reduction of pain and improve functional disability in adult women

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group (A)	Experimental	Laser with traditional exercises	Device: Laser Therapy Other: Traditional exercises
Group (B)	Placebo Comparator	Placebo LASER with traditional exercises	Other: Traditional exercises Other: Placebo laser

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser Therapy	Device	High-intensity	Group (A)	High power

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity	By Visual Analogue Sclae (VAS)	At the beginning and at after 12 session (1 month)

Secondary Outcomes

Measure	Description	Time Frame
Pressure pain threshold	By pressure algometer	At the beginning and at after 12 session (1 month)

Other Outcomes

Measure	Description	Time Frame
Functional disability	By Oswestry index (Arabic version)	At the beginning and at after 12 session (1 month)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kafr Al-Sheikh University		Kafr ash Shaykh			Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

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Browse Branches

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