Condition category
Musculoskeletal Diseases
Date applied
13/09/2010
Date assigned
08/12/2010
Last edited
08/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susanna Maddali-Bongi

ORCID ID

Contact details

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

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 measures

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

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

http://www.unifi.it/

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

Publication citations

Additional files

Editorial Notes