Diathermy Compared With Sham Diathermy in Doms Management | NCT02367079

Studies
Diathermy Compared With Sham Diathermy in Doms Management

NCT02367079

Sponsor

Studi Fisioterapici di Montagna

Status

Terminated

Last Update Posted

Feb 20, 2015Estimated

Enrollment

25Actual

Phase

Phase 4

Conditions

Musculoskeletal Diseases

Interventions

Diathermy

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

1 day data collection

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jan 21, 2015

First Submission Date that Met QC Criteria

Feb 12, 2015

First Posted Date

Feb 20, 2015Estimated

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

Feb 12, 2015

Last Update Posted Date

Feb 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To investigate the effect of hand massage, switched on diathermy or sham/switched off diathermy on DOMS in a group of athletes suffering DOMS after a ski mountaineering race.

Detailed Description

This study examine DOMS in athletes following a ski mountaineering race, pain measured with numbering pain rating scale NPRS and perceived global improvement (PGIC) after treatment have been measured after a massage treatment, a diathermy treatment and a sham diathermy treatment.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Switched on diathermy	Active Comparator	Switched on diathermy was used on DOMS compared to sham diathermy	Device: Diathermy
Switched OFF diathermy	Sham Comparator	Switched OFF diathermy was used on DOMS compared to REAL diathermy	Device: Diathermy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diathermy	Device	Sham diathermy vs switched on diathermy effect on pain where assessed	Switched OFF diathermy Switched on diathermy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numering pain rating scale	Numering pain rating scale was assessed pre e post treatment	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Healthy patients who complaints about D.O.M.S. after a skimountaneering race

Exclusion Criteria:

- Patient who complain of pathology such trauma or declaring consuming drugs for pain management where excluded from the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
LORENZO VISCONTI, Bsc	Studi Fisioterapici di Montagna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Studi fisioterapici di Montagna		Aosta	Aosta	11100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003972	Diathermy

Ancestor Terms

ID	Term
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided