Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The rehabilitation of facial involvement in systemic sclerosis: efficacy of the combination of Kabat's technique, connective tissue massage and kinesitherapy - a randomised controlled trial
Acronym
Study hypothesis
Systemic sclerosis is a connective tissue disease characterised by induration of the skin and internal organs, by joint modifications and muscle impairment. Skin fibrosis leads to tissue retraction and atrophy, and consequently to disability and reduction of patients' quality of life.
This trial aims to assess the efficacy of a rehabilitation programme based on the combination of Kabat's technique, connective massage and kinesitherapy specifically conceived for the face of systemic sclerosis patients.
Ethics approval
Not provided at time of registration.
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Systemic sclerosis
Intervention
Intervention group: 20 patients treated for 9 weeks (twice a week, 1 hour per session) with a combined face rehabilitation programme (Kabat's technique, connective tissue massage, kinesitherapy and home exercise programme)
Control group: 20 patients were assigned only to home exercise programme.
All patients were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The following were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up:
1. Improvement of facial skin score (modified Rodnan Skin Score)
2. Mouth opening (distance in centimetres between the tips of upper and lower right incisive teeth)
Secondary outcome measures
The following were assessed at baseline, end of treatment (after 9 weeks) and after 9 weeks of follow-up:
1. Facial systemic sclerosis disability, assessed by the Mouth Handicap In Systemic Sclerosis (MHISS) scale
2. Quality of life, assessed by the 36-item Short Form (SF-36) Health Survey and Health Assessment Questionnaire (HAQ)
Overall trial start date
15/02/2007
Overall trial end date
10/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, no age limits
2. Systemic sclerosis patients fulfilling the American College of Rheumatology (ACR) criteria with facial involvement assessed by a Rodnan skin score greater than or equal to 1
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
40
Participant exclusion criteria
Does not meet the inclusion criteria
Recruitment start date
15/02/2007
Recruitment end date
10/01/2008
Locations
Countries of recruitment
Italy
Trial participating centre
Villa Monna Tessa
Florence
50139
Italy
Sponsor information
Organisation
University of Florence (Italy)
Sponsor details
Department of Medicine
Viale Morgagni
85
Florence
50134
Italy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Florence (Italy) - Department of Medicine
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