Systemic SclerosisNCT05907200
Ultrasound Therapy and Manual Therapy in Digital Ischemic Ulcers
A study testing combination ultrasound therapy and manual therapy and manual therapy in people with Systemic Sclerosis, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- combination ultrasound therapy and manual therapy and manual therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone
Palermo, 90127
About this study
Official title: Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
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?
Read more
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
- Being tested
- combination ultrasound therapy and manual therapy, manual therapy
- Keywords
- rehabilitation, skin ulcer, ultrasound therapy, disability
- Medical subject headings
- Scleroderma, Systemic, Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination ultrasound therapy and manual therapyOther
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 therapyOther
manual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: combination ultrasound therapy and manual therapy |
| Control Group | Placebo comparator | It received rehabilitation treatment consisting of manual therapy alone Receives: Other: manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity
Duruoz's hand index. The total score ranges from 0-90 with higher scores indicating poorer hand functioning.
Measured: after 4 weeks of treatment
Secondary outcomes (3)
pain intensity
numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain.
Measured: after 4 weeks of treatment
ulcer assessment
Pressure Sore Status Tool; The score is between 13 and 65. Higher total scores indicated more severe wound status.
Measured: after 4 weeks of treatment
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.
Measured: after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Giulia Letizia Mauro, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907200
- Sponsor's protocol ID
- MFR0022023
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound in Combination With Manual Therapy in the Treatment of Ischemic Digital Ulcers in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05907200
- Acronym / sponsor ID
- MFR0022023
- Conditions
- Systemic Sclerosis
- Keywords
- rehabilitation, skin ulcer, ultrasound therapy, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: combination ultrasound therapy and manual therapyIt received rehabilitation treatment consisting of a combination of manual therapy (McMennel joint manipulation, pumping and connective tissue massage) and US water immersion. |
| Control Group | Placebo comparator | Other: manual therapyIt received rehabilitation treatment consisting of manual therapy alone |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- presence of skin lesions due to other conditions (e.g., trauma);
- pregnancy;
- infectious diseases (e.g. HIV, HBV, HCV);
- myositis;
- arthritis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination ultrasound therapy and manual therapyThe 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. | Other | Treatment Group |
| manual therapymanual treatment lasting 90 minutes which involved a combination of three different techniques: McMennel manipulation, connective tissue massage and pumping mobilization technique. | Other | Control Group |
Primary outcome
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.
3 secondary outcomes
pain intensity
Time frame: after 4 weeks of treatment
ulcer assessment
Time frame: after 4 weeks of treatment
disease-related quality of life
Time frame: after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination ultrasound therapy and manual therapy and manual therapy in people with Systemic Sclerosis, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional capacity (time frame: after 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.