Clinical trial NCT01343147: Deep Versus Superficial Heating in Patients With Knee Osteoarthritis
Official title: Deep Versus Superficial Heating in Patients With Knee Osteoarthritis: a Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Hyperthermia
Microwave diathermy
Hot packs
Pain
Physical function
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)
timeFrame: 12 months
Secondary outcomes:
measure: British Medical Research Council (BMRC) rating scale
timeFrame: 6 months
measure: Pain visual analogue scale (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Carlo Bertolini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giombini A, Giovannini V, Di Cesare A, Pacetti P, Ichinoseki-Sekine N, Shiraishi M, Naito H, Maffulli N. Hyperthermia induced by microwave diathermy in the management of muscle and tendon injuries. Br Med Bull. 2007;83:379-96. doi: 10.1093/bmb/ldm020.
citation: Di Cesare A, Giombini A, Dragoni S, Agnello L, Ripani M, Saraceni VM, Maffulli N. Calcific tendinopathy of the rotator cuff. Conservative management with 434 Mhz local microwave diathermy (hyperthermia): a case study. Disabil Rehabil. 2008;30(20-22):1578-83. doi: 10.1080/09638280701786351.
citation: Giombini A, Di Cesare A, Safran MR, Ciatti R, Maffulli N. Short-term effectiveness of hyperthermia for supraspinatus tendinopathy in athletes: a short-term randomized controlled study. Am J Sports Med. 2006 Aug;34(8):1247-53. doi: 10.1177/0363546506287827. Epub 2006 Apr 24.
citation: Kaplan LD, Chu CR, Bradley JP, Fu FH, Studer RK. Recovery of chondrocyte metabolic activity after thermal exposure. Am J Sports Med. 2003 May-Jun;31(3):392-8. doi: 10.1177/03635465030310031101.
citation: Weinberger A, Fadilah R, Lev A, Levi A, Pinkhas J. Deep heat in the treatment of inflammatory joint disease. Med Hypotheses. 1988 Apr;25(4):231-3. doi: 10.1016/0306-9877(88)90036-9.
citation: Cetin N, Aytar A, Atalay A, Akman MN. Comparing hot pack, short-wave diathermy, ultrasound, and TENS on isokinetic strength, pain, and functional status of women with osteoarthritic knees: a single-blind, randomized, controlled trial. Am J Phys Med Rehabil. 2008 Jun;87(6):443-51. doi: 10.1097/PHM.0b013e318174e467.
citation: Robertson VJ, Ward AR, Jung P. The effect of heat on tissue extensibility: a comparison of deep and superficial heating. Arch Phys Med Rehabil. 2005 Apr;86(4):819-25. doi: 10.1016/j.apmr.2004.07.353.