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Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis

P

Petz Aladar County Teaching Hospital

Status

Unknown

Conditions

Hip Osteoarthritis

Treatments

Device: Continuous ultrasound therapy
Device: US and electrotherapy (sonotens)
Device: Sham ultrasound therapy
Device: pulsed ultrasound therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03952221
PetzAladarCountyTH

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 4 patient groups, including a placebo group

Usual physiotherapy and continuous ultrasound therapy
Active Comparator group
Description:
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).
Treatment:
Device: Continuous ultrasound therapy
Usual physiotherapy and pulsed ultrasound therapy
Active Comparator group
Description:
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).
Treatment:
Device: pulsed ultrasound therapy
Usual physiotherapy and sonotens therapy
Active Comparator group
Description:
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).
Treatment:
Device: US and electrotherapy (sonotens)
Usual physiotherapy and sham ultrasound therapy
Placebo Comparator group
Description:
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).
Treatment:
Device: Sham ultrasound therapy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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