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临床试验/NCT05870852
NCT05870852尚未招募不适用

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

Istanbul University0 个研究点目标入组 30 人开始时间: 2023年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
Scleroderma Hand Mobility Test (HAMIS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

ESWT

Experimental

All individuals who will participate in the study will be treated 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.

干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)

ESWT+PNF

Experimental

PNF stretching techniques will be applied in addition to ESWT. 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.

干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)

ESWT+PNF

Experimental

PNF stretching techniques will be applied in addition to ESWT. 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.

干预措施: PNF (Other)

结局指标

主要结局

Scleroderma Hand Mobility Test (HAMIS)

时间窗: on the first day and three week change

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.

次要结局

  • The Scleroderma Health Assessment Questionnaire (SHAQ)(on the first day and three week change)
  • Arm, Shoulder and Hand Problems Questionnaire (DASH)(on the first day and three week change)
  • The Pittsburgh Sleep Quality Index (PSQI)(on the first day and three week change)
  • Visual Analog Scale (VAS)(on the first day and three week change)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tugba Civi Karaaslan

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

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