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 |
| Protocol serial number | N/A |
| Sponsor | University of Florence (Italy) |
| Funder | University of Florence (Italy) |
- 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
Scientific
Viale Pieraccini 18
Florence
50139
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled single centre trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Fist closure (cm) at baseline, end of treatment (after 9 weeks) and 9 week follow-up. |
| Key secondary outcome measure(s) |
The following were assessed at baseline, end of treatment (after 9 weeks) and 9 week follow-up: |
| Completion date | 10/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Female |
| Target sample size at registration | 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
50139
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
