Manual lymph drainage in systemic sclerosis

ISRCTN	ISRCTN24123906
DOI	https://doi.org/10.1186/ISRCTN24123906
Protocol serial number	N/A
Sponsor	University of Florence (Italy)
Funder	University of Florence (Italy) - Department of Medicine

Submission date: 13/09/2010
Registration date: 08/12/2010
Last edited: 22/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Susanna Maddali-Bongi
Scientific

Villa Monna Tessa
Department of Medicine
Division of Rheumatology
University of Florence
Florence
50139
Italy

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Manual lymph drainage improves upper limb oedema and hand function in patients with systemic sclerisis (SSC) in oedematour phase
Study objectives	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(s)	The Ethics Committee of Azienda University Hospital Careggi (Comitato Etico Azienda Ospedaliera Universitaria Careggi [AOUC]) approved on the 27th September 2010 (ref: 514/2010)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	15/03/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	32
Key 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
Key exclusion criteria	1. Patients that do not meet the inclusion criteria 2. Ongoing infections and thrombosis
Date of first enrolment	10/03/2009
Date of final enrolment	15/03/2010

Locations

Countries of recruitment

Italy

Study participating centre

Villa Monna Tessa

Florence
50139
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/10/2021: Internal review.