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

Viale Pieraccini 18
Florence
50139
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of connective tissue massage and Mc Mennell joint manipulation in the rehabilitative treatment of the hands in patients with systemic sclerosis: a randomised controlled trial

Acronym

Study hypothesis

Systemic sclerosis is a connective tissue disease characterised by induration of the skin and internal organs, joint modifications and muscle impairment. Deformations of hands lead to a severe loss of range of motion and functionality, affecting quality of life and activities of daily living.

This trial aims to assess the effectiveness of a rehabilitation programme based on the association of connective massage and Mc Mennell joint manipulation specifically conceived for hands of systemic sclerosis patients.

Ethics approval

Not provided at the time of registration

Study design

Randomised controlled single centre 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 systemic sclerosis patients treated for a 9-week period (twice a week, 1 hour per session) with a hand rehabilitation programme based on connective tissue massage and Mc Mennell joint manipulation. Mc Mennell joint manipulation is a technique aiming to recover the "joint play", i.e. the involuntary, subtle range of motion that normal joints display on multiple planes, necessary for normal voluntary joint mobility. It improves articular movement, reduces pain and stretches articular capsulae and ligaments.

Control group: 20 participants assigned only to a home exercise programme.

Patients were assessed at baseline, end of treatment (after 9 weeks) and 9 week follow-up.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Fist closure (cm) at baseline, end of treatment (after 9 weeks) and 9 week follow-up.

Secondary outcome measures

The following were assessed at baseline, end of treatment (after 9 weeks) and 9 week follow-up:
1. Hand disability, assessed by the Hand Mobility in Scleroderma (HAMIS) test and the Cochin Hand Functional Disability scale
2. Quality of life, assessed by 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. Caucasian systemic sclerosis patients (diagnosed according the American College of Rheumatology [ACR] criteria) with the typical systemic sclerosis joint involvement (stiffness and loss of joint function due to flexion contractures, caused by progressive sclerotic retraction of skin, subcutaneous tissues and tendon sheaths)

Participant type

Patient

Age group

Other

Gender

Female

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

Viale Pieraccini 18
Florence
50139
Italy

Sponsor information

Organisation

University of Florence (Italy)

Sponsor details

Department of Internal 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)

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