Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

NCT03952221 | Unknown

• 1 other identifier: PetzAladarCountyTH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Osteoarthritis

Keywords

hip osteoarthritis; sonotens; pulsed ultrasound; continuous ultrasound

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

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).

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).

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).

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).

Device: Sham ultrasound therapy

Interventions

Continuous ultrasound therapy DEVICE

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

Usual physiotherapy and continuous ultrasound therapy

pulsed ultrasound therapy DEVICE

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

Usual physiotherapy and pulsed ultrasound therapy

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

Usual physiotherapy and sonotens therapy

Sham ultrasound therapy DEVICE

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

Usual physiotherapy and sham ultrasound therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Petz Aladar County Teaching Hospital: lead

Study Sites (2)

Petz Aladár County Teaching Hospital

Győr, 9025, Hungary

Location

Zsigmondy Vilmos Harkány Spa Hospital

Harkány, 7815, Hungary

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Márta Király

  Petz Aladar County Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: June 4, 2018
• Primary Completion: August 3, 2019
• Study Completion: August 30, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

HU (2)