NCT05224674

Brief Summary

There is no scientific study in the literature regarding the use of shock wave therapy in hip osteoarthritis. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in hip osteoarthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

January 18, 2022

Last Update Submit

November 28, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale (VAS)

    patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.

    at baseline.

  • Visual Analogue Scale (VAS)

    patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome

    4 weeks after baseline.

  • Visual Analogue Scale (VAS)

    patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.

    8 weeks after baseline.

Secondary Outcomes (3)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    at baseline.

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    4 weeks after baseline.

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    8 weeks after baseline.

Study Arms (3)

Large-Focused Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR
Device: Extracorporeal Shock Wave Therapy (ESWT)

Controlled-Unfocused Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR
Device: Extracorporeal Shock Wave Therapy (ESWT)

Sham Extracorporeal Shock Wave Therapy

SHAM COMPARATOR
Device: Extracorporeal Shock Wave Therapy (ESWT)

Interventions

The ESWT device is product of Elettronica Pagani, Italy.

Controlled-Unfocused Extracorporeal Shock Wave TherapyLarge-Focused Extracorporeal Shock Wave TherapySham Extracorporeal Shock Wave Therapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral or bilateral hip osteoarthritis

You may not qualify if:

  • other disorders that are contraindications for shockwave therapy, not have received ESWT treatment before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Volkan Şah

Van, 65040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Volkan Şah

    Yüzüncü Yıl Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 4, 2022

Study Start

January 1, 2022

Primary Completion

August 29, 2022

Study Completion

September 30, 2022

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations