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Completed

NCT Number: NCT05907200

Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

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?

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Palermo, 90127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Registry information

Official study title

Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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