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Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

Primary Purpose

Hip Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Continuous ultrasound therapy
pulsed ultrasound therapy
US and electrotherapy (sonotens)
Sham ultrasound therapy
Sponsored by
Petz Aladar County Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip osteoarthritis, sonotens, pulsed ultrasound, continuous ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Petz Aladár County Teaching Hospital
  • Zsigmondy Vilmos Harkány Spa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Usual physiotherapy and continuous ultrasound therapy

Usual physiotherapy and pulsed ultrasound therapy

Usual physiotherapy and sonotens therapy

Usual physiotherapy and sham ultrasound therapy

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

change in severity of pain at rest
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in severity of pain at rest
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
change in function
change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 2. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
change in function
change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
change in function
change from baseline physical function measured by the 6-minute walking test. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. Patients can walk at a self chosen walking speed, can have a rest or can use a walking aid. The accomplished distance is the total distance at the end of the 6 minutes.
change in function
change from baseline physical function measured by the 6-minute walking test at Week 12. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. Patients can walk at a self chosen walking speed, can have a rest or can use a walking aid. The accomplished distance is the total distance at the end of the 6 minutes.
change in quality of life
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 2. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
change in quality of life
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 12. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.

Secondary Outcome Measures

Full Information

First Posted
May 14, 2019
Last Updated
July 7, 2019
Sponsor
Petz Aladar County Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03952221
Brief Title
Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis
Official Title
Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
August 3, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petz Aladar County Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip osteoarthritis, sonotens, pulsed ultrasound, continuous ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual physiotherapy and continuous ultrasound therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Usual physiotherapy and pulsed ultrasound therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Usual physiotherapy and sonotens therapy
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Usual physiotherapy and sham ultrasound therapy
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Continuous ultrasound therapy
Intervention Description
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
Intervention Name(s)
pulsed ultrasound therapy
Intervention Description
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
Intervention Name(s)
US and electrotherapy (sonotens)
Intervention Description
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
Intervention Name(s)
Sham ultrasound therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
change in severity of pain at rest
Description
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Time Frame
Week 0 and Week 2
Title
change in severity of pain at rest
Description
change from baseline severity of pain at rest recorded on a 100 mm visual analogue scale, where 0 mm represents no pain, 100 mm represents unbearable pain.
Time Frame
Week 0 and Week 12
Title
change in function
Description
change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 2. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
Time Frame
Week 0 and Week 2
Title
change in function
Description
change from baseline Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 12. It is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). All the items are scored on a 100mm visual analogue scale. Values are summed up for a combined WOMAC score. The lower score represents better outcome.
Time Frame
Week 0 and Week 12
Title
change in function
Description
change from baseline physical function measured by the 6-minute walking test. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. Patients can walk at a self chosen walking speed, can have a rest or can use a walking aid. The accomplished distance is the total distance at the end of the 6 minutes.
Time Frame
Week 0 and Week 2
Title
change in function
Description
change from baseline physical function measured by the 6-minute walking test at Week 12. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. Patients can walk at a self chosen walking speed, can have a rest or can use a walking aid. The accomplished distance is the total distance at the end of the 6 minutes.
Time Frame
Week 0 and Week 12
Title
change in quality of life
Description
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 2. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
Time Frame
Week 0 and Week 2
Title
change in quality of life
Description
change from baseline quality of life (36-Item Short Form Health Survey /SF-36/) at week 12. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more the disability, i.e. a score of zero is equivalent to maximum disability.
Time Frame
Week 0 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márta Király
Organizational Affiliation
Petz Aladar County Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petz Aladár County Teaching Hospital
City
Győr
ZIP/Postal Code
9025
Country
Hungary
Facility Name
Zsigmondy Vilmos Harkány Spa Hospital
City
Harkány
ZIP/Postal Code
7815
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

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