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Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03952221
Enrollment
60
Registered
2019-05-16
Start date
2018-06-04
Completion date
2019-08-30
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis

Keywords

hip osteoarthritis, sonotens, pulsed ultrasound, continuous ultrasound

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.

Interventions

DEVICEContinuous 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 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

DEVICEUS 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

DEVICESham 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

Sponsors

Petz Aladar County Teaching Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in severity of pain at restWeek 0 and Week 2change 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 functionWeek 0 and Week 2change 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 quality of lifeWeek 0 and Week 2change 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.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026