Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

NCT ID: NCT05907200

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-12-15

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?

Conditions

Systemic Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

combination ultrasound therapy and manual therapy

Intervention Type: OTHER

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.

Control Group

It received rehabilitation treatment consisting of manual therapy alone

Group Type: PLACEBO_COMPARATOR

manual therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Palermo, , Italy

Countries

Italy

Other Identifiers

MFR0022023

Identifier Type: -

Identifier Source: org_study_id