Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Manual lymph drainage improves upper limb oedema and hand function in patients with systemic sclerisis (SSC) in oedematour phase
Acronym
Study hypothesis
In early systemic sclerosis (SSc), hand oedema is often present. This leads to hand pain and disability and, ultimately, to impaied perceived quality of life (QOL).
Manual lymph drainage (MLD) stimulates lymphatic system and reduces oedema.
This trial aims to evaluate the efficacy of MLD in reducing oedema and in improving functionality of the hands and perceived QoL in SSc patients in oedematous phase.
Ethics approval
The Ethics Committee of Azienda University Hospital Careggi (Comitato Etico Azienda Ospedaliera Universitaria Careggi [AOUC]) approved on the 27th September 2010 (ref: 514/2010)
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format. Please use contact details below to request a patient information sheet
Condition
Systemic sclerosis
Intervention
Intervention group: 16 patients treated for 5 weeks (twice a week, 1 hour per session) with manual lymph drainage at upper limbs.
Control group: 16 patients asked to maintain their lifestyle for the duration of the study and to refrain from starting any new regular physical activity or exercise programs unrelated to the study.
All patients assessed at baseline, at end of treatment (after 5 weeks) and after 9 weeks of follow-up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The following items assessed at baseline, at the end of treatment (after 5 weeks) and after 9 weeks of follow-up.
1. Hands volume assessed by volumetric test
2. Hands function evaluated by Hand Mobility in Scleroderma (HAMIS) test, assessed in both hands
Secondary outcome measures
The following items assessed at baseline, at the end of treatment (after 5 weeks) and after 9 weeks of follow-up:
1. 4 visual assessment scales (VAS) 0-10 (0= best condition;10= worst condition) by which the patient self-assesses the entity (in the previous week) of
1.1. Hand oedema
1.2. Hand pain
1.3. The interference of hand oedema on the daily activities
1.4. The inferference of hand pain on the daily activities.
2. Quality of life, assessed by the 36-item Short Form (SF-36) Health Survey and Health Assessment Questionnaire (HAQ)
Overall trial start date
10/03/2009
Overall trial end date
15/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Both males and females, no age limits
2. Systemic sclerosis patients with oedematous hands fulfilling the American College of Rheumatology (ACR) criteria
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
32 patients affected with systemic sclerosis
Participant exclusion criteria
1. Patients that do not meet the inclusion criteria
2. Ongoing infections and thrombosis
Recruitment start date
10/03/2009
Recruitment end date
15/03/2010
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
Basic results (scientific)
Publication list