Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Systemic Sclerosis
- Sponsor
- University of Palermo
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- functional capacity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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?
Investigators
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo
Eligibility Criteria
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.
Outcomes
Primary Outcomes
functional capacity
Time Frame: after 4 weeks of treatment
Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.
Secondary Outcomes
- disease-related quality of life(after 4 weeks of treatment)
- ulcer assessment(after 4 weeks of treatment)
- pain intensity(after 4 weeks of treatment)