Efficacy of connective tissue massage and Mc Mennell joint manipulation in the rehabilitative treatment of the hands in patients with systemic sclerosis

ISRCTN	ISRCTN36648909
DOI	https://doi.org/10.1186/ISRCTN36648909
Secondary identifying numbers	N/A

Submission date: 12/12/2008
Registration date: 23/12/2008
Last edited: 23/12/2008

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

Viale Pieraccini 18
Florence
50139
Italy

Study information

Study design	Randomised controlled single centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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
Study objectives	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(s)	Not provided at the time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/02/2007
Completion date	10/01/2008

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Female
Target number of participants	40
Key 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)
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	15/02/2007
Date of final enrolment	10/01/2008

Locations

Countries of recruitment

Italy

Study participating centre

Viale Pieraccini 18

Florence
50139
Italy

Sponsor information

University of Florence (Italy)
University/education

Department of Internal 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)

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