Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

NCT01800955 | Completed

• 1 other identifier: 1347/2012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

physical therapy; diathermy; knee; osteoarthritis; pain; physical function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

resistive capacitive diathermy

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

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

sham placebo group

SHAM COMPARATOR

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

Interventions

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

resistive capacitive diathermy

sham placebo resistive capacitive diathermy treatment 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

sham placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Rome, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Fever; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: February 28, 2013
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 3, 2014

Record last verified: 2014-04

Locations

IT (1)