Effectiveness of ESWT & PNF in Scleroderma With Calcinosis

Status Not yet recruiting

Clinical Trial Summary

Investigation of the effects of ESWT and PNF exercises added to ESWT on calcinosis in Ssc patients. Calcinosis cutis is a common, difficult-to-treat manifestation of systemic sclerosis associated with high morbidity. The aim of this study is to investigate the efficacy of ESWT therapy for calcinosis cutis in Ssc patients. The effects on grip strength, sleep, function and quality of life will be investigated.

Clinical Trial Description

In Ssc patients, ESWT and PNF exercises that they take to ESWT should not be taken on calcinosis. Calcinosis cutis is a common, difficult-to-treat manifestation of disseminated systemic sclerosis with high morbidity. The effects on machine power, sleep, function and quality of life will be investigated. Evaluation Methods - Treatment ROM (with goniometer), second force (dynamometer), ultrasound (evaluation of calcinosis size), DASH (evaluation of ability to maintain upper extremity activities) , HAMIS (hand function test patient-specific functions assessment), Pitsburgh Sleep Quality Index (PUKI) - (Sleep assessment assessment), Pain assessment (with VAS), Health assessment questionnaire (SHAQ) (health status assessment) will be evaluated. As a result of the evaluation, two groups will be separated and one group will be ESWT, one group will be applied PNF stretching in addition to EWST. Treatment PNf Tension : 10 sec against max resistance. The time will be done with isometric contraction. 5 sec. It will wait for active circuit. 8-10 will be repeated. 10 seconds between applications. listening range will be left. PNF will be applied 3 times a week, once a week. ESWT: ESWT will be applied 3 times in total, 20 minutes once a week. 2000 impulses will be applied on calcinosis. The Patients will do the taught PNF exercises once a day as a home program. H1: PNF stretching exercises go on calcinosis when Ssc patients go to ESWT and ESWT. H2: ESWT and decreased to ESWT in Ssc patients PNF stretching exercises were not effective on calcinosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05870852
Study type	Interventional
Source	Istanbul University
Contact	TUGBA CIVI KARAASLAN, PhD
Phone	+905343855606
Email	tugba.civi@iuc.edu.tr
Status	Not yet recruiting
Phase	N/A
Start date	May 22, 2023
Completion date	May 22, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02798055` - Bosentan Treatment of Digital Ulcers Related to Systemic Sclerosis
Completed	`NCT01959815` - Novel Screening Strategies for Scleroderma PAH
Completed	`NCT03274076` - Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)	Phase 1/Phase 2
Completed	`NCT02915835` - Riociguat in Scleroderma Associated Digital Ulcers	Phase 2
Active, not recruiting	`NCT01895244` - Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis	Phase 2
Completed	`NCT00930683` - A Study to Evaluate Safety and Tolerability of Multiple Doses of MEDI-546 in Adult Subjects With Scleroderma	Phase 1
Completed	`NCT00883129` - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)	Phase 2
Completed	`NCT00074568` - Scleroderma Registry
Recruiting	`NCT04797286` - Sildenafil for Early Pulmonary Vascular Disease in Scleroderma	Phase 2
Completed	`NCT03222492` - Brentuximab Vedotin for Systemic Sclerosis	Phase 1/Phase 2
Completed	`NCT03207997` - MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients	N/A
Recruiting	`NCT04464434` - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis	Phase 4
Recruiting	`NCT04246528` - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)	N/A
Completed	`NCT05080738` - Upper Extremity Home Exercises in Patients With Scleroderma	N/A
Recruiting	`NCT03726398` - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH	Phase 2/Phase 3
Recruiting	`NCT05085444` - A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma	Early Phase 1
Completed	`NCT02062125` - Calcinosis in a Single-Center Scleroderma Population
Completed	`NCT04588714` - Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention	N/A
Recruiting	`NCT05635266` - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Completed	`NCT02835196` - Optical Elastography of Systemic Sclerosis Skin

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms