Deep Versus Superficial Heating in Patients With Knee Ost... | NCT01343147

Studies
Deep Versus Superficial Heating in Patients With Knee Osteoarthritis

NCT01343147

Sponsor

Catholic University of the Sacred Heart

Status

Completed

Last Update Posted

Mar 5, 2014Estimated

Enrollment

54Actual

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Microwave diathermy
Superficial hyperthermia

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Apr 26, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2014

Last Update Posted Date

Mar 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlo Bertolini, Principal Investigator, Catholic University of the Sacred HeartPrincipal Investigator

Lead Sponsor

Catholic University of the Sacred HeartOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deep hyperthermia	Other	Microwave diathermy	Other: Microwave diathermy
Superficial hyperthermia	Other	Hot packs	Other: Superficial hyperthermia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microwave diathermy	Other	Deep tissue heating via microwave diathermy	Deep hyperthermia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC scale)		12 months

Secondary Outcomes

Measure	Description	Time Frame
British Medical Research Council (BMRC) rating scale		6 months
Pain visual analogue scale (VAS)		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlo Bertolini, M.D.	Catholic University of the Sacred Heart	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient clinic of the Dept. Of Gerontology, Geriatrics and Physiatrics		Rome		00168	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17942453	Background	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.
18608369	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.

ID	Term
D020370	Osteoarthritis, Knee
D000084462	Hyperthermia
D010146	Pain

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases