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OpenTrials
Completed

NCT Number: NCT01343147

Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

Heat therapy is frequently prescribed to patients with symptomatic knee osteoarthritis (OA). Deep hyperthermia via localized microwave diathermy is effective in several musculoskeletal painful conditions. However, the efficacy of superficial heating is controversial. Furthermore, no clinical trials have yet directly compared the effects of these treatment modalities in knee OA. Hence, the purpose of the present study is to compare the effects of deep and superficial hyperthermia, induced via microwave diathermy and hot packs, respectively, on pain and function in patients with symptomatic knee OA.

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Key information

Conditions

Knee Osteoarthritis Arthritis Body Temperature Changes Heat Stress Disorders Hyperthermia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged 18 years or older
  • Moderate, mono or bilateral knee osteoarthritis
  • Pain lasting for at least three weeks

Exclusion criteria

  • Inability or unwillingness to sign informed consent
  • Previous surgery on the affected knee
  • Intra-articular injections with steroids or hyaluronic acid in prior 6 months
  • Physical therapy for knee problems in prior 6 months
  • Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee
  • Chronic NSAID or steroid treatment
  • Cognitive or psychiatric disorders
  • Pregnancy or breastfeeding
  • Contraindications to hyperthermia (cancer in prior 2 years or active cancer treatment, local thrombosis, impaired arterial circulation, altered cutaneous thermal sensitivity, local infections or systemic acute infections, metal implants or prosthesis, severe osteoporosis

Treatment and study plan

Microwave diathermy

Other

Deep tissue heating via microwave diathermy

Superficial hyperthermia

Other

Superficial heating via hot pack application

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)

    Time frame: 12 months

Secondary outcomes

  1. British Medical Research Council (BMRC) rating scale

    Time frame: 6 months

  2. Pain visual analogue scale (VAS)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2011
Registry last updated
Mar 5, 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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