Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

NCT ID: NCT01343147

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Deep hyperthermia

Microwave diathermy

Group Type OTHER

Microwave diathermy

Intervention Type OTHER

Deep tissue heating via microwave diathermy

Superficial hyperthermia

Hot packs

Group Type OTHER

Superficial hyperthermia

Intervention Type OTHER

Superficial heating via hot pack application

Interventions

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Microwave diathermy

Deep tissue heating via microwave diathermy

Intervention Type OTHER

Superficial hyperthermia

Superficial heating via hot pack application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

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Carlo Bertolini

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Bertolini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University of the Sacred Heart

Locations

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

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 17942453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18608369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16636345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12750132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3367814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18496246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15827938 (View on PubMed)

Other Identifiers

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533/10

Identifier Type: -

Identifier Source: org_study_id

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