NCT04206722

Brief Summary

The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

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

June 1, 2012

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

6.5 years

First QC Date

December 16, 2019

Last Update Submit

December 19, 2019

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • change from baseline Visual Analogue Scale (VAS) score at 10 days and 30 days

    10mm to 100mm, higher scores mean a worse outcome

    at baseline, after 10 days, after 30 days

Secondary Outcomes (1)

  • change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 10 days and 30 days

    at baseline, after 10 days, after 30 days

Study Arms (2)

Treatment group

EXPERIMENTAL

Shock Wave therapy on the affected hip, for 10 days, 1 application every 2 days

Device: Shock Wave Therapy

Control group

ACTIVE COMPARATOR

Ultrasound therapy on the affected hip, for 10 days, 1 application daily

Device: Ultrasound

Interventions

Shock Wave TherapyDEVICE

Shock Wave therapy - hip osteoarthritis program

Treatment group
UltrasoundDEVICE

Ultrasound 0.7W/cm2

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 or ultrasound application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Extracorporeal Shockwave TherapyUltrasonography

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Irsay Laszlo, MD, PhD

    University of Medicine and Pharmacy Iuliu Hatieganu

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 20, 2019

Study Start

June 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 20, 2019

Record last verified: 2019-12