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Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

Primary Purpose

Scleroderma, Calcinosis Cutis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (ESWT)
PNF
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring scleroderma, ESWT, PNF techniques

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ESWT

    ESWT+PNF

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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).
    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).
    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.

    Full Information

    First Posted
    May 4, 2023
    Last Updated
    May 12, 2023
    Sponsor
    Istanbul University
    Collaborators
    Istanbul University - Cerrahpasa (IUC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05870852
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 22, 2023 (Anticipated)
    Primary Completion Date
    April 22, 2024 (Anticipated)
    Study Completion Date
    May 22, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University
    Collaborators
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scleroderma, Calcinosis Cutis
    Keywords
    scleroderma, ESWT, PNF techniques

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESWT
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    ESWT+PNF
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Extracorporeal Shock Wave Therapy (ESWT)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    PNF
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Scleroderma Hand Mobility Test (HAMIS)
    Description
    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.
    Time Frame
    on the first day and three week change
    Secondary Outcome Measure Information:
    Title
    The Scleroderma Health Assessment Questionnaire (SHAQ)
    Description
    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.
    Time Frame
    on the first day and three week change
    Title
    Arm, Shoulder and Hand Problems Questionnaire (DASH)
    Description
    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).
    Time Frame
    on the first day and three week change
    Title
    The Pittsburgh Sleep Quality Index (PSQI)
    Description
    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).
    Time Frame
    on the first day and three week change
    Title
    Visual Analog Scale (VAS)
    Description
    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.
    Time Frame
    on the first day and three week change

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    TUGBA CIVI KARAASLAN, PhD
    Phone
    +905343855606
    Email
    tugba.civi@iuc.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    TUGBA CIVI KARAASLAN, PhD
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

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