Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers

Not Applicable

Completed

• Conditions: Systemic Sclerosis
• Interventions: Other: combination ultrasound therapy and manual therapy; Other: manual therapy

• Registration Number: NCT05907200
• Lead Sponsor: University of Palermo

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 available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-15
• Status Verified: 2023-06
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Last Update Submitted: 2023-06-18
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	combination ultrasound therapy and manual therapy	It received rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping and connective tissue massage) and US water immersion.
Control Group	manual therapy	It received rehabilitation treatment consisting of manual therapy alone

Primary Outcome Measures

Name	Time	Method
functional capacity	after 4 weeks of treatment	Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.

Secondary Outcome Measures

Name	Time	Method
disease-related quality of life	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.
ulcer assessment	after 4 weeks of treatment	Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status.
pain intensity	after 4 weeks of treatment	numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.

Trial Locations

Locations (1)

Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone; 🇮🇹 Palermo, Italy