Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05907200
• Other study ID #: MFR0022023
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: June 2023
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 15, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• combination 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.
• manual therapy
manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.

Locations

Country	Name	City	State
Italy	Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pain intensity	numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.	after 4 weeks of treatment
Secondary	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
Secondary	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