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Completed

NCT Number: NCT01800955

Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale

    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

    assessment of changing of pain and physical functioning in patients affected by osteoarthritis of lower limbs

Secondary outcomes

  1. changing of visual analogic scale (VAS)

    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

    assessment of changing of pain

  2. MRC scale = Medical Research Council Scale

    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

    assessment of changing of femoral quadriceps strength

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Feb 28, 2013
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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