SclerodermaNCT05870852
Effectiveness of ESWT and PNF in Scleroderma With Calcinosis
A study testing Extracorporeal Shock Wave Therapy (ESWT) and PNF in people with Scleroderma and Calcinosis Cutis, run by Istanbul University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, Calcinosis Cutis
- What is being tested?
- Extracorporeal Shock Wave Therapy (ESWT) and PNF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2023to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being diagnosed with a known additional rheumatological or chronic disease
- Having a deformity that prevents doing the exercises
- Cognitive impairment
- Being pregnant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scleroderma, Calcinosis Cutis
- Being tested
- Extracorporeal Shock Wave Therapy (ESWT), PNF
- Keywords
- scleroderma, ESWT, PNF techniques
- Medical subject headings
- Scleroderma, Diffuse, Calcinosis Cutis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (ESWT)Device
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.
PNFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT) |
| 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. Receives: Device: Extracorporeal Shock Wave Therapy (ESWT); Other: PNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on the first day and three week change
Secondary outcomes (4)
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.
Measured: on the first day and three week change
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).
Measured: on the first day and three week change
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).
Measured: on the first day and three week change
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.
Measured: on the first day and three week change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start22 May 2023 (estimated)
- Primary completion22 Apr 2024 (estimated)
- Study completion22 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
- Investigators
- TUGBA CIVI KARAASLAN, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870852
- Sponsor's protocol ID
- IstanbulC5
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of ESWT and PNF Techniques Added to ESWT in Individuals With Scleroderma With Calcinosis
- ClinicalTrials.gov ID
- NCT05870852
- Acronym / sponsor ID
- IstanbulC5
- Conditions
- Scleroderma, Calcinosis Cutis
- Keywords
- scleroderma, ESWT, PNF techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 22 May 2023 (estimated)
- Primary completion
- 22 Apr 2024 (estimated)
- Study completion
- 22 May 2024 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Device: Extracorporeal Shock Wave Therapy (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. |
| ESWT+PNF | Experimental | Device: Extracorporeal Shock Wave Therapy (ESWT), Other: PNFPNF 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Being diagnosed with a known additional rheumatological or chronic disease
- Having a deformity that prevents doing the exercises
- Cognitive impairment
- Being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ESWT, ESWT+PNF |
| PNFPNF 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. | Other | ESWT+PNF |
Primary outcome
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.
4 secondary outcomes
The Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: 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 Pittsburgh Sleep Quality Index (PSQI)
Time frame: on the first day and three week change
Visual Analog Scale (VAS)
Time frame: on the first day and three week change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA CIVI KARAASLAN, PhD principal investigator
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (ESWT) and PNF in people with Scleroderma and Calcinosis Cutis, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TUGBA CIVI KARAASLAN, PhD (+905343855606, tugba.civi@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scleroderma Hand Mobility Test (HAMIS) (time frame: on the first day and three week change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.