Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

• ClinicalTrials.gov Identifier: NCT05907200
• Recruitment Status: Completed
• First Posted: June 18, 2023
• Last Update Posted: June 22, 2023
• Sponsor: University of Palermo
• Information provided by (Responsible Party): Prof.ssa Giulia Letizia Mauro, University of Palermo

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Systemic Sclerosis	Other: combination ultrasound therapy and manual therapy; Other: manual therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
• Actual Study Start Date: April 1, 2022
• Actual Primary Completion Date: November 30, 2022
• Actual Study Completion Date: December 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. pain intensity [ Time Frame: after 4 weeks of treatment ]
   numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
2. ulcer assessment [ Time Frame: after 4 weeks of treatment ]
   Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status.
3. disease-related quality of life [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Italy

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone

Palermo, Italy, 90127

Sponsors and Collaborators

University of Palermo

More Information

• Responsible Party: Prof.ssa Giulia Letizia Mauro, Professor, University of Palermo
• ClinicalTrials.gov Identifier: NCT05907200
• Other Study ID Numbers: MFR0022023
• First Posted: June 18, 2023
• Last Update Posted: June 22, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Prof.ssa Giulia Letizia Mauro, University of Palermo:

rehabilitation; skin ulcer; ultrasound therapy; disability

Additional relevant MeSH terms:

Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Pathologic Processes; Connective Tissue Diseases; Skin Diseases