Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

Scleroderma Clinical Trial

Official title:

The Effectiveness of ESWT and PNF Techniques Added to ESWT in Individuals With Scleroderma With Calcinosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05870852
• Other study ID #: IstanbulC5
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: May 22, 2024

Study information

• Verified date: May 2023
• Source: Istanbul University
• Contact: TUGBA CIVI KARAASLAN, PhD
• Phone: +905343855606
• Email: tugba.civi[@]iuc.edu.tr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 22, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Calcinosis Cutis
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Device:
• Extracorporeal Shock Wave Therapy (ESWT)
ESWT will be done once a week for 4-5 minutes in total 3 times with ESWT. 2000 impulses will be applied on calcinosis with 2.4 bar pressure and 5.0 Hz frequency.

Other:
• PNF
PNF stretching techniques: It will be done with isometric contraction for 10 seconds against maximum resistance. 8-10 repetitions will be done. A 10-second listening interval will be left for active relaxation of the patient between the applications. PNF application will be done by the physiotherapist once a week. You will be asked to do the PNF stretching exercises taught once daily as a home program.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	Istanbul University - Cerrahpasa (IUC)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scleroderma Hand Mobility Test (HAMIS)	The hand function test developed for SSc patients will be used to assess patients' specific functions. The ability to use the hand in daily work and the limitation of movement will be evaluated. Finger movements, grasping, releasing, pronation, supination movements will be scored between 0-3. A lower total score of the scale indicates better functional activity.	on the first day and three week change
Secondary	The Scleroderma Health Assessment Questionnaire (SHAQ)	The survey includes; Five visual analog scales questioning disease severity in general, as well as Raynaud's phenomenon, digital ulcer, gastrointestinal, and pulmonary respiratory symptoms. These questions are calculated separately and the score of each is between 0-3. The scale includes a 20-question Health Assessment Questionnaire (HAQ) that evaluates the functional competence level of the patient. This section includes fine motor movements of the upper extremity, locomotor activities of the lower extremity, and activities related to both the upper and lower extremities. The questions are scored between 0-3 (0=No difficulty and 3=Cannot). While scoring the sections, the highest score among the items that make up those 18 sections will be accepted as the section score. The score of each category will be summed and divided by 8, which is the total number of categories, to obtain the SHAQ score.	on the first day and three week change
Secondary	Arm, Shoulder and Hand Problems Questionnaire (DASH)	The ability of patients to perform certain upper extremity activities will be evaluated with a 30-item questionnaire. Patients will be asked to rate their level of difficulty with daily living on a five-point Likert scale. The calculation of the questionnaire, which can be used in any person with one or more upper extremity musculoskeletal disorders, is as follows: scoring formula = ([(sum of n answers)/n] -1). Higher scores indicate a higher level of disability and severity, while lower scores indicate a lower level of disability. The total score ranges from 0 (no disability) to 100 (most severe disability).	on the first day and three week change
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	It is a sleep questionnaire that helps to evaluate sleep quality, amount of sleep, presence and severity of sleep disorder for the last month. There are 19 items in this scale and subjective sleep quality (C1), time to fall asleep (C2), sleep duration (C3), habitual sleep efficiency (C4), sleep disorders (C5), use of sleeping pills (C6) and daytime dysfunction ( It measures seven sub-components of sleep quality, including C7). The total PUKI score is obtained by summing the seven sub-scores and the total score is between 0-21. The PUKI total score clearly distinguishes good sleepers (PUKI total score =5) from poor sleepers (PUKI >5).	on the first day and three week change
Secondary	Visual Analog Scale (VAS)	The Pain Assessment will be evaluated with the visual analog scale (VAS). In order to be able to evaluate the pain subjectively, the individual will be asked to mark three different pain intensity levels in the joint with calcinosis on the pain scale evaluated out of 10: at rest, during activity and during sleep. The patient was asked to rate this scale (0: no pain, 10: severe pain) and determine a number accordingly for the severity of pain. Determining the pain level of the test by marking is an important advantage for ease of application.	on the first day and three week change