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Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

C

Catholic University of the Sacred Heart

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)
Other: sham placebo resistive capacitive diathermy treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01800955
1347/2012

Details and patient eligibility

About

It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison with a "sham" diathermy treatment. The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce pain and inflammation and allowing healing processes. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy). Each subject, randomly assigned to either resistive capacitive diathermy treatment (group 1) or sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster Universities Arthritis Index) to assess pain and physical functioning, a visual analogic scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale). Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views

Exclusion criteria

  • Neurologic Disorders involving the lower limbs
  • Systemic inflammatory disorders
  • pace-maker implantation
  • Severe heart disease
  • Acute infections or bone tuberculosis
  • Acute skin diseases
  • History of surgery on the affected knee
  • Cognitive or psychiatric disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

resistive capacitive diathermy
Experimental group
Description:
in the resistive capacitive diathermy protocol patients are administered the resistive capacitive diathermy treatment for a thirty minutes session, three times per week for a total of ten sessions
Treatment:
Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)
sham placebo group
Sham Comparator group
Description:
The sham treatment is administered with the resistive capacitive diathermy device set on "on" but not active (not supplying energy) with the same type of application, the same frequency and duration of experimental diathermy group
Treatment:
Other: sham placebo resistive capacitive diathermy treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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