Effectiveness of ESWT and PNF in Scleroderma With Calcinosis

May 12, 2023 updated by: Tugba Civi Karaaslan, Istanbul University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESWT
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.
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.
Experimental: ESWT+PNF
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Scleroderma Hand Mobility Test (HAMIS)
Time Frame: 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.
on the first day and three week change

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Scleroderma Health Assessment Questionnaire (SHAQ)
Time Frame: on the first day and three week change
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
Arm, Shoulder and Hand Problems Questionnaire (DASH)
Time Frame: on the first day and three week change
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
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: on the first day and three week change
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
Visual Analog Scale (VAS)
Time Frame: on the first day and three week change
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TUGBA CIVI KARAASLAN, PhD, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IstanbulC5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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