Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

NCT01343147 | Completed

• 1 other identifier: 533/10
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Hyperthermia; Microwave diathermy; Hot packs; Pain; Physical function

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)

  12 months

Secondary Outcomes (2)

• British Medical Research Council (BMRC) rating scale

  6 months

• Pain visual analogue scale (VAS)

  6 months

Study Arms (2)

Deep hyperthermia

OTHER

Microwave diathermy

Other: Microwave diathermy

Superficial hyperthermia

OTHER

Hot packs

Other: Superficial hyperthermia

Interventions

Microwave diathermy OTHER

Deep tissue heating via microwave diathermy

Deep hyperthermia

Superficial hyperthermia OTHER

Superficial heating via hot pack application

Superficial hyperthermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Rome, 00168, Italy

Location

Related Publications (7)

• 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.

  PMID: 17942453 BACKGROUND

• 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.

  PMID: 18608369 BACKGROUND

• 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.

  PMID: 16636345 BACKGROUND

• 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.

  PMID: 12750132 BACKGROUND

• 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.

  PMID: 3367814 BACKGROUND

• 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.

  PMID: 18496246 BACKGROUND

• 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.

  PMID: 15827938 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Hyperthermia; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Carlo Bertolini, M.D.

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2011
• First Posted: April 27, 2011
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

IT (1)