Systemic Sclerosis
Conditions
Keywords
rehabilitation, skin ulcer, ultrasound therapy, disability
Brief summary
The objective of this before-after non-randomized trial study is to evaluate the efficacy of ultrasound therapy in combination with manual therapy in the management of systemic sclerosis patients with IDU. The main questions it intends to answer are: • Is this combination of treatments effective in these patients in terms of improvement in hand functional ability, pain relief, injury healing, and quality of life? Participants will receive rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping, and connective tissue massage) and US water immersion. The researchers will compare the group of participants, called the treatment group, with a control group to see if: • Is the combined treatment of ultrasound therapy and manual therapy more effective in these patients than manual therapy alone?
Interventions
OTHERcombination ultrasound therapy and manual therapy
The proposed manual therapy lasted 90 minutes and involved a combination of three different techniques: McMennel manipulation, connective tissue massage and mobilization technique of pumping. Patients in the treatment group also received a treatment with US (I-Tech medical device certified UT2 CE0476) in combination with manual therapy. Dipping technique was applied with a frequency of 1 MHz, intensity of 1W/cm2, duty cycle of 60% and a duration of 15 minutes per session.
OTHERmanual therapy
manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.
Sponsors
University of Palermo
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of SSc according to the ACR and EULAR criteria * presence of IDU in active phase * naïve to rehabilitation treatment for their hands and upper limbs * written in-formed consent to participate in the study.
Exclusion criteria
* presence of skin lesions due to other conditions (e.g., trauma); * pregnancy; * infectious diseases (e.g. HIV, HBV, HCV); * myositis; * arthritis; * other rheumatological diseases and immunodepression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional capacity | after 4 weeks of treatment | Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity | after 4 weeks of treatment | numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain. |
| ulcer assessment | after 4 weeks of treatment | Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status. |
| disease-related quality of life | after 4 weeks of treatment | The 36-Item Short Form Health Survey; The score ranges from 0 to 100, where higher scores indicate improved health. |
Countries
Italy
Outcome results
None listed