search
Back to results

Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
combination ultrasound therapy and manual therapy
manual therapy
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring rehabilitation, skin ulcer, ultrasound therapy, disability

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Control Group

Arm Description

It received rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping and connective tissue massage) and US water immersion.

It received rehabilitation treatment consisting of manual therapy alone

Outcomes

Primary Outcome Measures

functional capacity
Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.

Secondary Outcome Measures

pain intensity
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
ulcer assessment
Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status.
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.

Full Information

First Posted
June 7, 2023
Last Updated
June 18, 2023
Sponsor
University of Palermo
search

1. Study Identification

Unique Protocol Identification Number
NCT05907200
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

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

5. 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
rehabilitation, skin ulcer, ultrasound therapy, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
It received rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping and connective tissue massage) and US water immersion.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
It received rehabilitation treatment consisting of manual therapy alone
Intervention Type
Other
Intervention Name(s)
combination ultrasound therapy and manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.
Primary Outcome Measure Information:
Title
functional capacity
Description
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
Secondary Outcome Measure Information:
Title
pain intensity
Description
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
Time Frame
after 4 weeks of treatment
Title
ulcer assessment
Description
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
Title
disease-related quality of life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

We'll reach out to this number within 24 hrs