Clinical trial NCT03952221: Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis
Official title: Effects of Various Types of Ultrasound Therapy in Hip Osteoarthritis - a Double-blinded, Placebo-controlled, Follow-up Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: hip osteoarthritis
sonotens
pulsed ultrasound
continuous ultrasound
Lead sponsor: Petz Aladar County Teaching Hospital
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in severity of pain at rest
timeFrame: Week 0 and Week 2
measure: change in severity of pain at rest
timeFrame: Week 0 and Week 12
measure: change in function
timeFrame: Week 0 and Week 2
measure: change in function
timeFrame: Week 0 and Week 12
measure: change in function
timeFrame: Week 0 and Week 2
measure: change in function
timeFrame: Week 0 and Week 12
measure: change in quality of life
timeFrame: Week 0 and Week 2
measure: change in quality of life
timeFrame: Week 0 and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Győr
country: Hungary
facility: Petz Aladár County Teaching Hospital
city: Harkány
country: Hungary
facility: Zsigmondy Vilmos Harkány Spa Hospital
Study officials:
affiliation: Petz Aladar County Teaching Hospital
name: Márta Király
role: PRINCIPAL_INVESTIGATOR
References: