Condition category
Musculoskeletal Diseases
Date applied
12/12/2008
Date assigned
23/12/2008
Last edited
23/12/2008
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
Viale Pieraccini 18
Florence
50139
Italy

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

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