Clinical trial NCT05870852: Effectiveness of ESWT and PNF in Scleroderma With Calcinosis
Official title: The Effectiveness of ESWT and PNF Techniques Added to ESWT in Individuals With Scleroderma With Calcinosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scleroderma
Calcinosis Cutis
Keywords: scleroderma
ESWT
PNF techniques
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2023-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with SSc according to ACR/EULAR 2013 criteria
* Being diagnosed with Calcinosis by a physician
* Have the ability to adapt to exercises
* Stability of medical treatments

Exclusion Criteria:

* Being diagnosed with a known additional rheumatological or chronic disease
* Having a deformity that prevents doing the exercises
* Cognitive impairment
* Being pregnant

Primary outcomes:
measure: Scleroderma Hand Mobility Test (HAMIS)
timeFrame: on the first day and three week change
Secondary outcomes:
measure: The Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: on the first day and three week change
measure: Arm, Shoulder and Hand Problems Questionnaire (DASH)
timeFrame: on the first day and three week change
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: on the first day and three week change
measure: Visual Analog Scale (VAS)
timeFrame: on the first day and three week change
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: TUGBA CIVI KARAASLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: