Condition category
Haematological Disorders
Date applied
27/07/2011
Date assigned
13/09/2011
Last edited
09/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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).

Please note that as of 09/11/2012, the anticipated end date for this study has been updated from 31/12/2011 to 16/04/2012

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 March 2011

Study design

Interventional pilot multicenter study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below 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

To evaluate the efficacy, safety and tolerability of HILT in the treatment of chronic articular inflammatory processes in adult haemophiliac patients:
1. At baseline (T1), T4, T7 and T10 visits the pain will be measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain)
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

Centro Emofilia e Trombosi
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