Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Study Overview
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Brief Summary
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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?

Official Title
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Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: combination ultrasound therapy and manual therapy
* Other: manual therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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<br>* 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.<br>|
| Placebo Comparator: Control Group<br>It received rehabilitation treatment consisting of manual therapy alone | Other: manual therapy<br>* manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional capacity | Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning. | after 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain. | 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. | 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. | after 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, skin ulcer, ultrasound therapy, disability