Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

NCT05907200 | Completed

• 1 other identifier: MFR0022023
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

rehabilitation; skin ulcer; ultrasound therapy; disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• pain intensity

  after 4 weeks of treatment

• ulcer assessment

  after 4 weeks of treatment

• disease-related quality of life

  after 4 weeks of treatment

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

It received rehabilitation treatment consisting of manual therapy alone

Other: manual therapy

Interventions

combination ultrasound therapy and manual therapy 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.

Treatment Group

manual therapy OTHER

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

Control Group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

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

Palermo, 90127, Italy

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Skin Ulcer

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 15, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)