Condition category
Haematological Disorders
Date applied
27/07/2011
Date assigned
13/09/2011
Last edited
14/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Haemophilia is an inherited condition that affects the blood's ability to clot, which can lead to bleeding into the joints and inflammation. The aim of this study is to assess the effectiveness, safety and tolerability of high-intensity laser therapy (HILT) for the treatment of joint inflammation in haemophiliac patients.

Who can participate?
Patients aged 18 and over with haemophilia A

What does the study involve?
All participants receive nine applications of HILT (three applications per week over 3 weeks). Pain is assessed before, during and after treatment.

What are the possible benefits and risks of participating?
It is not known for certain whether the participant will benefit, but as HILT is already used successfully in other diseases, it could help. The risks of HILT are the following reactions related to the application area: warm with possibly burning sensation, local sensitivity alteration, tingling, numbness, rush and oedema (build-up of fluid).

Where is the study run from?
IRCCS Ospedale Maggiore di Milano (Italy)

When is the study starting and how long is it expected to run for?
May 2011 to December 2011

Who is funding the study?
Baxter (Italy)

Who is the main contact?
Dr Michele Schino

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elena Santagostino

ORCID ID

Contact details

Centro Emofilia e Trombosi
Angelo Bianchi Bonomi
Dipartimento di Medicina Interna
IRCCS Ospedale Maggiore di Milano
Via Pace
9
Milan
20122
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HILT-haemophilia-2011

Study information

Scientific title

To evaluate the efficacy, safety and tolerability of Hilterapia® (High Intensity Laser Therapy) in the chronic articular inflammatory processes in haemophilic adult patients: an interventional pilot multicentre study

Acronym

Study hypothesis

Previous experimental studies (Fortune, 2002) indicate how the laser can be antagonistic to degenerative phenomenon, experimentally induced, to stimulate neo-chondrogenisis with formation of simil-jalina cartilage and to induce synovial hyperplasia; these effects appear to be particularly related to variations in light intensity (power intensity: W/cm2) rather than when supplied in doses (Joule J/cm2).

Ethics approval

Ethics Comittee of the Foundation of the Institute of Medical Research of a Public Nature and the City Counil of Milan [Comitato di Etica della Fondazione IRCCS Ca´ Granda Ospedale Maggiore Policlinico di Milano], 22/03/2011

Study design

Interventional pilot multicenter study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Haemophilia

Intervention

Therapy with the equipment ASA-SH1 involves 9 applications (3 applications per week x 3 weeks) of Hilterapia® with the following operating parameters:
1. Fluence: 360 to 760 mJ/cm2
2. Frequency: 10 - 35 Hz
3. Total energy: 500 to 1,500 J
4. Time of application: 6 - 11 minutes
Subjects will be requested to attend 10 clinical visits in total: T1 (screening/first treatment), T2-T9 (HILT application visits) and T10 (final visit).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Pain will be measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline (T1), T4, T7 and T10 visits
2. Nieschl’s Score and the articular state will be measured using Hemophilia Joint Health Score 2.0

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/05/2011

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult subjects with haemophilia A of any severity with or not suppressant
2. Age more than or equal to 18 years
3. Subjects who have been previously diagnosed with a chronic articular inflammatory process or hematoma
4. Subjects who have signed an informed written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15 (11 participants had been recruited by the end of the study)

Participant exclusion criteria

Subjects with under way bleeding

Recruitment start date

15/05/2011

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Italy

Trial participating centre

IRCCS Ospedale Maggiore di Milano
Milan
20122
Italy

Sponsor information

Organisation

Baxter (Italy)

Sponsor details

Piazzale dell'Industria
20
Rome
00144
Italy

Sponsor type

Industry

Website

http://www.baxter.com/

Funders

Funder type

Industry

Funder name

Baxter (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/02/2017: Plain English summary added. 09/11/2012: The overall trial end date was changed from 31/12/2011 to 16/04/2012.