Hip OsteoarthritisNCT03952221
Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis
A study testing Continuous ultrasound therapy, pulsed ultrasound therapy and US and electrotherapy (sonotens) in people with Hip Osteoarthritis, run by Petz Aladar County Teaching Hospital at 2 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Continuous ultrasound therapy, pulsed ultrasound therapy and US and electrotherapy (sonotens)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesHungary
- Study dates
- 4 Jun 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- tumour
- epilepsy
- pregnancy
- untreated hypertension
- heart failure (NYHA II-IV. stage)
- inflammatory rheumatic diseases
- hip arthroplasty
- pacemaker or intracardiac device
- severe osteoporosis
- osteomyelitis
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Petz Aladár County Teaching Hospital
Győr, 9025
Zsigmondy Vilmos Harkány Spa Hospital
Harkány, 7815
About this study
Official title: Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
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.
Read the 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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Continuous ultrasound therapy, pulsed ultrasound therapy, US and electrotherapy (sonotens), Sham ultrasound therapy
- Keywords
- hip osteoarthritis, sonotens, pulsed ultrasound, continuous ultrasound
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous ultrasound therapyDevice
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
pulsed ultrasound therapyDevice
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
US and electrotherapy (sonotens)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
Sham ultrasound therapyDevice
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 group | Role | What they receive |
|---|---|---|
| Usual physiotherapy and continuous ultrasound therapy | Active comparator | 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). Receives: Device: Continuous ultrasound therapy |
| Usual physiotherapy and pulsed ultrasound therapy | Active comparator | 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). Receives: Device: pulsed ultrasound therapy |
| Usual physiotherapy and sonotens therapy | Active comparator | 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). Receives: Device: US and electrotherapy (sonotens) |
| Usual physiotherapy and sham ultrasound therapy | Placebo comparator | 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). Receives: Device: Sham ultrasound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 and Week 2
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.
Measured: Week 0 and Week 12
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.
Measured: Week 0 and Week 2
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.
Measured: Week 0 and Week 12
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.
Measured: Week 0 and Week 2
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.
Measured: Week 0 and Week 12
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.
Measured: Week 0 and Week 2
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.
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start4 Jun 2018
- Primary completion3 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petz Aladar County Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Márta Király, Petz Aladar County Teaching Hospital
- Investigators
- Márta Király, Principal investigator, Petz Aladar County Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952221
- Sponsor's protocol ID
- PetzAladarCountyTH
- Status last verified
- Jul 2019
- First submitted
- 14 May 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
- ClinicalTrials.gov ID
- NCT03952221
- Acronym / sponsor ID
- PetzAladarCountyTH
- Conditions
- Hip Osteoarthritis
- Keywords
- hip osteoarthritis, sonotens, pulsed ultrasound, continuous ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Petz Aladar County Teaching HospitalUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 3 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual physiotherapy and continuous ultrasound therapy | Active comparator | Device: Continuous ultrasound therapyPatients 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). |
| Usual physiotherapy and pulsed ultrasound therapy | Active comparator | Device: pulsed ultrasound therapyPatients 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). |
| Usual physiotherapy and sonotens therapy | Active comparator | Device: US and electrotherapy (sonotens)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). |
| Usual physiotherapy and sham ultrasound therapy | Placebo comparator | Device: Sham ultrasound therapyPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous ultrasound therapycontinuous 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 | Usual physiotherapy and continuous ultrasound therapy |
| pulsed ultrasound therapypulsed 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 | Usual physiotherapy and pulsed ultrasound therapy |
| 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 | Usual physiotherapy and sonotens therapy |
| Sham ultrasound therapysham 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 | Device | Usual physiotherapy and sham ultrasound therapy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márta Király principal investigator
Petz Aladar County Teaching Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous ultrasound therapy, pulsed ultrasound therapy and US and electrotherapy (sonotens) in people with Hip Osteoarthritis, run by Petz Aladar County Teaching Hospital at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of pain at rest (time frame: Week 0 and Week 2). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.