NCT05870852

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

May 4, 2023

Last Update Submit

May 12, 2023

Conditions

SclerodermaCalcinosis Cutis

Keywords

sclerodermaESWTPNF techniques

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

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.

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.

Device: Extracorporeal Shock Wave Therapy (ESWT)Other: PNF

Interventions

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.

ESWTESWT+PNF
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.

ESWT+PNF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, DiffuseCalcinosis Cutis

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • TUGBA CIVI KARAASLAN, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TUGBA CIVI KARAASLAN, PhD

CONTACT

+905343855606tugba.civi@iuc.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 23, 2023

Study Start

May 22, 2023

Primary Completion

April 22, 2024

Study Completion

May 22, 2024

Last Updated

May 23, 2023

Record last verified: 2023-05