An interventional study of combination ultrasound therapy and manual therapy and manual therapy in Systemic Sclerosis, sponsored by University of Palermo. Completed at 1 site in Italy. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of Palermo · Not applicable, Interventional, and Treatment
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:
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:
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 45 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
It received rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping and connective tissue massage) and US water immersion.
Other: combination ultrasound therapy and manual therapy
It received rehabilitation treatment consisting of manual therapy alone
Other: 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.
manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.
functional capacity
Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.
Time frame: after 4 weeks of treatment
pain intensity
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
Time frame: after 4 weeks of treatment
ulcer assessment
Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status.
Time frame: after 4 weeks of treatment
disease-related quality of life
The 36-Item Short Form Health Survey; The score ranges from 0 to 100, where higher scores indicate improved health.
Time frame: after 4 weeks of treatment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University of Palermo