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Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03952221
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Márta Király, Petz Aladar County Teaching Hospital

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.


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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

Resource links provided by the National Library of Medicine


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952221


Locations
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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
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Principal Investigator: Márta Király Petz Aladar County Teaching Hospital

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Responsible Party: Márta Király, chief physician, Petz Aladar County Teaching Hospital
ClinicalTrials.gov Identifier: NCT03952221     History of Changes
Other Study ID Numbers: PetzAladarCountyTH
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Márta Király, Petz Aladar County Teaching Hospital:
hip osteoarthritis
sonotens
pulsed ultrasound
continuous ultrasound

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases