Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

Hip Osteoarthritis Clinical Trial

Official title:

Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03952221
• Other study ID #: PetzAladarCountyTH
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: July 2019
• Source: Petz Aladar County Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 30, 2019
• Est. primary completion date: August 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Hungary	Petz Aladár County Teaching Hospital	Gyor
Hungary	Zsigmondy Vilmos Harkány Spa Hospital	Harkány

Sponsors (1)

Lead Sponsor	Collaborator
Petz Aladar County Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 0 and Week 2
Primary	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.	Week 0 and Week 12
Primary	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.	Week 0 and Week 2
Primary	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.	Week 0 and Week 12
Primary	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.	Week 0 and Week 2
Primary	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.	Week 0 and Week 12
Primary	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.	Week 0 and Week 2
Primary	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.	Week 0 and Week 12