Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

NCT ID: NCT01800955

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

resistive capacitive diathermy

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

Group Type: EXPERIMENTAL

resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)

Intervention Type: DEVICE

The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W. It is used to reduce pain and inflammation and allowing healing processes. diathermy treatment is administered for a thirty minutes session, three times per week for a total of ten sessions.

sham placebo group

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

Group Type: SHAM_COMPARATOR

sham placebo resistive capacitive diathermy treatment

Intervention Type: OTHER

The sham treatment is administered with the diathermy device set on "on" but not active (not supplying energy) and the treatment session has the same modalities, frequency and duration of experimental diathermy group

Interventions

resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)

The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W. It is used to reduce pain and inflammation and allowing healing processes. diathermy treatment is administered for a thirty minutes session, three times per week for a total of ten sessions.

Intervention Type: DEVICE

sham placebo resistive capacitive diathermy treatment

The sham treatment is administered with the diathermy device set on "on" but not active (not supplying energy) and the treatment session has the same modalities, frequency and duration of experimental diathermy group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Carlo Bertolini

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital "A. Gemelli", Catholic University of the Sacred Heart

Rome, , Italy

Countries

Italy

Other Identifiers

1347/2012

Identifier Type: -

Identifier Source: org_study_id