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Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)
sham placebo resistive capacitive diathermy treatment
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring physical therapy, diathermy, knee, osteoarthritis, pain, physical function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

resistive capacitive diathermy

sham placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

changing of visual analogic scale (VAS)
assessment of changing of pain
MRC scale = Medical Research Council Scale
assessment of changing of femoral quadriceps strength

Full Information

First Posted
February 22, 2013
Last Updated
April 2, 2014
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT01800955
Brief Title
Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis
Official Title
The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
physical therapy, diathermy, knee, osteoarthritis, pain, physical function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
resistive capacitive diathermy
Arm Type
Experimental
Arm Description
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
Arm Title
sham placebo group
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham placebo resistive capacitive diathermy treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale
Description
assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs
Time Frame
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 Measure Information:
Title
changing of visual analogic scale (VAS)
Description
assessment of changing of pain
Time Frame
baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment
Title
MRC scale = Medical Research Council Scale
Description
assessment of changing of femoral quadriceps strength
Time Frame
baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital "A. Gemelli", Catholic University of the Sacred Heart
City
Rome
Country
Italy

12. IPD Sharing Statement

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Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

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