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NCT Number: NCT07579585

Effects of Photobiomodulation in Hemophilia Patients.

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

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Key information

Conditions

Hemarthrosis, Knee Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hemarthrosis Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemorrhage Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sundas Foundation

Sialkot, Punjab Province, 5100, Pakistan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Radiation

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Muhammad Asif Javed, PhD*

CONTACT

[email protected]

+923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Photobiomodulation on Knee Hemarthosis in Patients With Hemophilia.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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