Completed

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

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What is being tested

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

+ sham placebo resistive capacitive diathermy treatment

DeviceOther
Who is being recruted

Arthritis+9

+ Body Temperature Changes

+ Joint Diseases

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorCatholic University of the Sacred Heart
Last updated: April 3, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorCatholic University of the Sacred Heart
Last updated: April 3, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBody Temperature ChangesJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFeverOsteoarthritisPainOsteoarthritis, Knee

Criteria

1 inclusion criteria required to participate
Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views

8 exclusion criteria prevent from participating
Acute infections or bone tuberculosis

Acute skin diseases

Cognitive or psychiatric disorders

History of surgery on the affected knee

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
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 II

Sham
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Rome, ItalyOpen University Hospital "A. Gemelli", Catholic University of the Sacred Heart in Google Maps
CompletedOne Study Center