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Effects of Photobiomodulation in Hemophilia Patients.

5. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
VAS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Zaira Zeeshan, MS, Riphah International University

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. april 2026

Primær fullføring (Antatt)

5. juli 2026

Studiet fullført (Antatt)

10. juli 2026

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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