Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | Placebo Comparator | It received rehabilitation treatment consisting of manual therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity | numerical rating scale; the total score ranges from 0 to 10, with higher scores indicating more pain. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone | Palermo | 90127 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 23, 2023 | |
| Reset | Feb 15, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2023 | Feb 15, 2024 |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D012883 | Skin Ulcer |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | after 4 weeks of treatment |