Knee Osteoarthritis
Conditions
Keywords
physical therapy, diathermy, knee, osteoarthritis, pain, physical function
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.
Interventions
DEVICEresistive 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.
OTHERsham 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
Sponsors
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale | baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment | assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | assessment of changing of pain |
| 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 | assessment of changing of femoral quadriceps strength |
Countries
Italy
Outcome results
None listed