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

Tracking Information

• First Submitted Date: June 7, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: April 1, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2023)

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.

Original Primary Outcome Measures (submitted: June 7, 2023)

functional capacity [ Time Frame: after 4 weeks of treatment ]

Duruoz's hand index

Current Secondary Outcome Measures (submitted: June 18, 2023)

• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: June 7, 2023)

• pain intensity [ Time Frame: after 4 weeks of treatment ]
  numerical rating scale
• ulcer assessment [ Time Frame: after 4 weeks of treatment ]
  Pressure Sore Status Tool
• disease-related quality of life [ Time Frame: after 4 weeks of treatment ]
  The 36-Item Short Form Health Survey

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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?

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: 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.
• 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.

Study Arms

• 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.
  Intervention: Other: combination ultrasound therapy and manual therapy
• Placebo Comparator: Control Group
  It received rehabilitation treatment consisting of manual therapy alone
  Intervention: Other: manual therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 7, 2023): 45
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 15, 2022
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT05907200
• Other Study ID Numbers: MFR0022023
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Prof.ssa Giulia Letizia Mauro, University of Palermo
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Palermo
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Palermo
• Verification Date: June 2023