Effects of Photobiomodulation in Hemophilia Patients.

May 5, 2026 updated by: Riphah International University

Effects of Photobiomodulation on Knee Hemarthosis in Patients With Hemophilia.

Hemophilia is a genetic bleeding disorder that commonly leads to knee hemarthrosis, causing pain, swelling, and reduced joint mobility in children. While standard treatments include clotting factor replacement and physiotherapy, additional non-invasive approaches are being explored. This study aims to evaluate the effects of photobiomodulation on knee hemarthrosis in male hemophilia patients aged 9-14 years. It focuses on determining whether this therapy can reduce pain and swelling and improve joint range of motion when used alongside

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hemophilia is a hereditary bleeding disorder characterized by a deficiency in clottingfactors VIII or IX, leading to spontaneous or trauma-induced internal bleeding, especially into muscles and joints. Knee hemarthrosis is among the most commonanddebilitating complications in pediatric hemophilia patients, contributing to chronicjoint pain, restricted mobility, and long-term deformities. Conventional management includes clotting factor replacement and physiotherapeutic interventions such as theRICE protocol. However, complementary, non-invasive strategies are increasinglybeing explored to enhance joint health and reduce recurrent bleeding episodes. Photobiomodulation (PBM), also known as low-level laser therapy (LLLT), has shown promising effects on reducing inflammation, promoting tissue repair, andmanaging musculoskeletal pain, but its role in managing hemarthrosis in hemophiliaremains underexplored. This quasi-experimental study aims to evaluate the effects of photobiomodulationonknee hemarthrosis in male hemophilia patients aged 9 to 14 years. The study will beconducted at Sundas Foundation, Sialkot, following ethical approval fromBASAR. Atotal sample size of 24 will be selected using non-probability convenient sampling.Patients will be receiving LLLT in addition to standard care for 10 minutes for 3 days a week after an acute internal bleed or swelling. The primary outcomes assessedwill include pain intensity (using the Visual Analogue Scale), swelling (using a measuringtape), and range of motion (measured with a goniometer). Data will be collectedpre- and post-intervention to observe the effectiveness of PBM in improving joint functionand reducing hemarthrosis severity. The data will be collected using SPSS version26.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Sialkot, Punjab Province, Pakistan, 5100
        • Recruiting
        • Sundas Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hemophilia patients with knee hemarthosis
  • Patients of age 9-14 yrs will be taken
  • Bothmaleand female population will be included

Exclusion Criteria:

  • Presence of open wounds at or near the treatment site.
  • Kneejoint subluxation.
  • Presence of congenital or acquired skeletal deformities.
  • Children diagnosed with cardiopulmonary dysfunctions.
  • Children with neurological deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: photobiomodulation
The intervention involves the application of low-level laser therapy (LLLT), also referred to as photobiomodulation (PBM), using a diode laser device with the intensity in the range of 1 to 500 mW . The laser was applied in continuous-wave mode directly to the skin over the knee joint at multiple anatomical points, including the medial, lateral, superior, and inferior aspects of the patella, covering 8 to 9 specific locations. Total treatment time will be 10 minutes, delivered with a spot size 13 Effects of Photobiomodulation o knee hemarthosis in children with Hemophilia ranging from 0.04 to 0.07 cm². During the procedure, patients are positioned in a supine posture with the knee slightly flexed (20-30°) to allow optimal access to the target areas.
Radiation: photobiomodulation
Photobiomodulation is a non-invasive therapy that uses low-level light (typically from lasers or LEDs) to stimulate cellular activity and promote healing. It works by enhancing mitochondrial function, increasing energy (ATP) production, and reducing inflammation. This therapy is commonly used for pain relief, tissue repair, and improving recovery in various clinical conditions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 3rd Day

The Visual Analogue Scale (VAS) is a simple and widely used tool to measure a person's pain intensity.

It typically consists of a 10 cm straight line, where:

One end represents "no pain" (0) The other end represents "worst possible pain" (10)

The patient is asked to mark a point on the line that best represents their level of pain. The distance from the "no pain" end to the marked point is then measured and recorded as the pain score.

VAS is easy to use, quick, and effective for tracking changes in pain over time in both clinical and research settings.
3rd Day
Measuring Tape
Time Frame: 3rd Day
A measuring tape in physiotherapy is a simple, flexible tool used to assess body dimensions such as limb length, girth, and joint swelling. It helps therapists monitor changes over time, evaluate muscle atrophy or edema, and track patient progress during rehabilitation.
3rd Day
Goniometer
Time Frame: 3rd Day
A goniometer is a scientific instrument used to measure angles. It is commonly used in fields like geometry, engineering, and healthcare. In medicine-especially in physical therapy and orthopedics-it helps measure the range of motion of joints in the human body. A typical goniometer consists of a protractor-like scale with two arms that can be aligned along the body part or object to determine the angle accurately.
3rd Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zaira Zeeshan, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Zaira Zeeshan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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