Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

Not Applicable

• Conditions: Hip Osteoarthritis
• Interventions: Device: pulsed ultrasound therapy; Device: US and electrotherapy (sonotens); Device: Sham ultrasound therapy; Device: Continuous ultrasound therapy

• Registration Number: NCT03952221
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-04
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-07
• Last Update Posted: 2019-07-09
• Primary Completion: 2019-08-03
• Study Completion: 2019-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual physiotherapy and pulsed ultrasound therapy	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).
Usual physiotherapy and sonotens therapy	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	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).
Usual physiotherapy and continuous ultrasound therapy	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).

Primary Outcome Measures

Name	Time	Method
change in function	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	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.
change in severity of pain at rest	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.

Trial Locations

Locations (2)

Zsigmondy Vilmos Harkány Spa Hospital; 🇭🇺 Harkány, Hungary

Petz Aladár County Teaching Hospital; 🇭🇺 Győr, Hungary