Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

NCT ID: NCT03952221

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-04

Study Completion Date

2019-08-30

Brief Summary

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This study evaluates the effects of various types of ultrasound therapy: continuous, pulsed, sham ultrasound and ultrasound combined with electrotherapy in patients with hip osteoarthritis. Beside ultrasound therapy, patients received usual physiotherapy (balneotherapy, exercise and massage) either.

Detailed Description

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During ultrasound therapy electrical energy is converted into mechanical energy and heat. It has physical, chemical and biologic effects, like thermal effect, micro-massage, increased tissue metabolism, capillary permeability and tissue healing. Continuous or pulsed forms can be applied.

As pulsed ultrasound therapy has no thermal effect, greater intensity can be used. It can alleviate acute pain and inflammation. Continuous ultrasound is usually used in chronic musculoskeletal diseases, in case of limitation of joint motion because its thermal effect.

Ultrasound can be combined with electrotherapy, when the effects of the two modalities are summed up.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual physiotherapy and continuous ultrasound therapy

Patients received usual physiotherapy (exercise, massage, balneotherapy) and continuous ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 1,5 W/cm2 SATA intensity) every working day for two weeks (10 occasions).

Group Type ACTIVE_COMPARATOR

Continuous ultrasound therapy

Intervention Type DEVICE

continuous US therapy once a day, 9 minutes/session for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity

Usual physiotherapy and pulsed ultrasound therapy

Patients received usual physiotherapy (exercise, massage, balneotherapy) and pulsed ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 1,5 W/cm2 SATA intensity, 50% duty cycle) every working day for two weeks (10 occasions).

Group Type ACTIVE_COMPARATOR

pulsed ultrasound therapy

Intervention Type DEVICE

pulsed US therapy once a day, 9 minutes/session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity, 50% duty cycle

Usual physiotherapy and sonotens therapy

Patients received usual physiotherapy (exercise, massage, balneotherapy) and sonotens therapy (BTL-4825S Premium device, head size of 5 cm2, 3 MHz frequency, 0,5 W/cm2 SATA intensity, transcutanous electrical nerve stimulation) every working day for two weeks (10 occasions).

Group Type ACTIVE_COMPARATOR

US and electrotherapy (sonotens)

Intervention Type DEVICE

US and electrotherapy (transcutaneous electrical nerve stimulation) once a day, 10 minutes /session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, US: 3 MHz frequency, 0,5 W/cm2 SATA intensity, TENS: application in conventional mode at 100 Hz frequency and 100 μs wavelength

Usual physiotherapy and sham ultrasound therapy

Patients received usual physiotherapy (exercise, massage, balneotherapy) and sham ultrasound therapy (BTL-4825S Premium device, head size of 5 cm2, 0 MHz frequency, 0 W/cm2 SATA intensity) every working day for two weeks (10 occasions).

Group Type PLACEBO_COMPARATOR

Sham ultrasound therapy

Intervention Type DEVICE

sham US therapy once a day for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 0 MHz frequency, 0 W/cm2 SATA intensity

Interventions

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Continuous ultrasound therapy

continuous US therapy once a day, 9 minutes/session for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity

Intervention Type DEVICE

pulsed ultrasound therapy

pulsed US therapy once a day, 9 minutes/session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity, 50% duty cycle

Intervention Type DEVICE

US and electrotherapy (sonotens)

US and electrotherapy (transcutaneous electrical nerve stimulation) once a day, 10 minutes /session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, US: 3 MHz frequency, 0,5 W/cm2 SATA intensity, TENS: application in conventional mode at 100 Hz frequency and 100 μs wavelength

Intervention Type DEVICE

Sham ultrasound therapy

sham US therapy once a day for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 0 MHz frequency, 0 W/cm2 SATA intensity

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients over 18 years of age with moderate hip osteoarthritis (radiologically Kellgren- Laurence II-III. stage)
* chronic hip pain (for at least 8 weeks)
* pain intensity is ≥ 50mm on a Visual Analogue Scale
* no physiotherapy or local injection (steroid, hialuronic acid) within 3 months before starting the study

Exclusion Criteria

* acute hip pain (duration is less than 8 weeks)
* steroid, hialuronic acid injection into the hip joint within 3 months
* physiotherapy of the hip within 3 months
* inflammatory hip osteoarthritis
* infection
* fever
* tumour
* epilepsy
* pregnancy
* untreated hypertension
* heart failure (NYHA II-IV. stage)
* inflammatory rheumatic diseases
* hip arthroplasty
* pacemaker or intracardiac device
* severe osteoporosis
* osteomyelitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Petz Aladar County Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Márta Király

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Márta Király

Role: PRINCIPAL_INVESTIGATOR

Petz Aladar County Teaching Hospital

Locations

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Petz Aladár County Teaching Hospital

Győr, , Hungary

Site Status

Zsigmondy Vilmos Harkány Spa Hospital

Harkány, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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PetzAladarCountyTH

Identifier Type: -

Identifier Source: org_study_id

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