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出境医 / 临床实验 / Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: Continuous ultrasound therapy Device: pulsed ultrasound therapy Device: US and electrotherapy (sonotens) Device: Sham ultrasound therapy Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : August 3, 2019
Estimated Study Completion Date : August 30, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: 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).
Device: 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

Active Comparator: 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).
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

Active Comparator: 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).
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

Placebo Comparator: 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).
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

Outcome Measures
Primary Outcome Measures :
  1. change in severity of pain at rest [ Time Frame: Week 0 and Week 2 ]
    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.

  2. change in severity of pain at rest [ Time Frame: Week 0 and Week 12 ]
    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.

  3. change in function [ Time Frame: Week 0 and Week 2 ]
    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.

  4. change in function [ Time Frame: Week 0 and Week 12 ]
    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.

  5. change in function [ Time Frame: Week 0 and Week 2 ]
    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.

  6. change in function [ Time Frame: Week 0 and Week 12 ]
    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.

  7. change in quality of life [ Time Frame: Week 0 and Week 2 ]
    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.

  8. change in quality of life [ Time Frame: Week 0 and Week 12 ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
Hungary
Petz Aladár County Teaching Hospital
Győr, Hungary, 9025
Zsigmondy Vilmos Harkány Spa Hospital
Harkány, Hungary, 7815
Sponsors and Collaborators
Petz Aladar County Teaching Hospital
Investigators
Layout table for investigator information
Principal Investigator: Márta Király Petz Aladar County Teaching Hospital
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE June 4, 2018
Estimated Primary Completion Date August 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • change in severity of pain at rest [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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 [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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 [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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 [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • change in severity of pain at rest [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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 [ Time Frame: Week 0 and Week 2 ]
    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 [ Time Frame: Week 0 and Week 12 ]
    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 [ Time Frame: Week 0 and Week 2 ]
    change from baseline physical function measured by the 6-minute walking test. The test measures the distance an individual 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 [ Time Frame: Week 0 and Week 12 ]
    change from baseline physical function measured by the 6-minute walking test at Week 12. The test measures the distance an individual 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 [ Time Frame: Week 0 and Week 2 ]
    change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).
  • change in quality of life [ Time Frame: Week 0 and Week 12 ]
    change from baseline qualiity of life measured by EuroQoL-5D. It has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where patients are asked to rate their health problems at five levels (no problems, slight problems, moderate problems, severe problems, extreme problems). It also includes a self-rating of health status on a visual analogue scale (EQ VAS) ranging from 0 to 100 (where 0 means the worst and 100 means the best health status).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis
Official Title  ICMJE Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hip Osteoarthritis
Intervention  ICMJE
  • Device: 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
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 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).
    Intervention: Device: Continuous ultrasound therapy
  • Active Comparator: 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).
    Intervention: Device: pulsed ultrasound therapy
  • Active Comparator: 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).
    Intervention: Device: US and electrotherapy (sonotens)
  • Placebo Comparator: 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).
    Intervention: Device: Sham ultrasound therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2019
Estimated Primary Completion Date August 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952221
Other Study ID Numbers  ICMJE PetzAladarCountyTH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Márta Király, Petz Aladar County Teaching Hospital
Study Sponsor  ICMJE Petz Aladar County Teaching Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Márta Király Petz Aladar County Teaching Hospital
PRS Account Petz Aladar County Teaching Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP