Manual lymph drainage in systemic sclerosis
| ISRCTN | ISRCTN24123906 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24123906 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Susanna Maddali-Bongi
Scientific
Scientific
Villa Monna Tessa
Department of Medicine
Division of Rheumatology
University of Florence
Florence
50139
Italy
Study information
| Study design | Single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use contact details below to request a patient information sheet |
| Scientific title | Manual lymph drainage improves upper limb oedema and hand function in patients with systemic sclerisis (SSC) in oedematour phase |
| 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(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) |
| 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 |
| 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 study start date | 10/03/2009 |
| Overall study end date | 15/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 32 patients affected with systemic sclerosis |
| 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 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
Study participating centre
Villa Monna Tessa
Florence
50139
Italy
50139
Italy
Sponsor information
University of Florence (Italy)
University/education
University/education
Department of Medicine
Viale Morgagni, 85
Florence
50134
Italy
| Website | http://www.unifi.it/ |
|---|---|
"ROR" |
https://ror.org/04jr1s763 |
Funders
Funder type
University/education
University of Florence (Italy) - Department of Medicine
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 | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
22/10/2021: Internal review.
