Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell); Other: sham placebo resistive capacitive diathermy treatment

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Device: 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.
SHAM_COMPARATOR: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (ESTIMATE): February 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2014
• Last Update Submitted That Met QC Criteria: April 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; knee; physical therapy; physical function; diathermy
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Body Temperature Changes; Heat Stress Disorders; Osteoarthritis; Osteoarthritis, Knee; Hyperthermia
• Other Study ID Numbers: 1347/2012