Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell); Other: sham placebo resistive capacitive diathermy treatment

• Registration Number: NCT01800955
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistive capacitive diathermy	resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)	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
sham placebo group	sham placebo resistive capacitive diathermy treatment	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

Primary Outcome Measures

Name	Time	Method
changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale	baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment	assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs

Secondary Outcome Measures

Name	Time	Method
changing of visual analogic scale (VAS)	baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment	assessment of changing of pain
MRC scale = Medical Research Council Scale	baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment	assessment of changing of femoral quadriceps strength

Trial Locations

Locations (1)

University Hospital "A. Gemelli", Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy