To evaluate the efficacy, safety and tolerability of Hilterapia® (High Intensity Laser Therapy) in the chronic articular inflammatory processes in haemophilic adult patients
| ISRCTN | ISRCTN02847428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02847428 |
| Secondary identifying numbers | HILT-haemophilia-2011 |
- Submission date
- 27/07/2011
- Registration date
- 13/09/2011
- Last edited
- 14/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Centro Emofilia e Trombosi
Angelo Bianchi Bonomi
Dipartimento di Medicina Interna
IRCCS Ospedale Maggiore di Milano
Via Pace, 9
Milan
20122
Italy
Study information
| Study design | Interventional pilot multicenter study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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. Nieschls Score and the articular state will be measured using Hemophilia Joint Health Score 2.0 |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/05/2011 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 (11 participants had been recruited by the end of the study) |
| Key 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 |
| Key exclusion criteria | Subjects with under way bleeding |
| Date of first enrolment | 15/05/2011 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
20122
Italy
Sponsor information
Industry
Piazzale dell'Industria, 20
Rome
00144
Italy
| Website | http://www.baxter.com/ |
|---|---|
"ROR" |
https://ror.org/02kf9ya90 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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.
