Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800955
• Other study ID #: 1347/2012
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: April 2, 2014
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2014
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

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

Locations

Country	Name	City	State
Italy	University Hospital "A. Gemelli", Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes