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Diathermy Compared With Sham Diathermy in Doms Management

Primary Purpose

Musculoskeletal Diseases

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Diathermy
Sponsored by
Studi Fisioterapici di Montagna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Studi fisioterapici di Montagna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Switched on diathermy

Switched OFF diathermy

Arm Description

Switched on diathermy was used on DOMS compared to sham diathermy

Switched OFF diathermy was used on DOMS compared to REAL diathermy

Outcomes

Primary Outcome Measures

Numering pain rating scale
Numering pain rating scale was assessed pre e post treatment

Secondary Outcome Measures

Full Information

First Posted
January 21, 2015
Last Updated
February 12, 2015
Sponsor
Studi Fisioterapici di Montagna
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1. Study Identification

Unique Protocol Identification Number
NCT02367079
Brief Title
Diathermy Compared With Sham Diathermy in Doms Management
Official Title
Diathermy Compared With Sham Diathermy in Doms Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
1 day data collection
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Studi Fisioterapici di Montagna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Switched on diathermy
Arm Type
Active Comparator
Arm Description
Switched on diathermy was used on DOMS compared to sham diathermy
Arm Title
Switched OFF diathermy
Arm Type
Sham Comparator
Arm Description
Switched OFF diathermy was used on DOMS compared to REAL diathermy
Intervention Type
Device
Intervention Name(s)
Diathermy
Intervention Description
Sham diathermy vs switched on diathermy effect on pain where assessed
Primary Outcome Measure Information:
Title
Numering pain rating scale
Description
Numering pain rating scale was assessed pre e post treatment
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LORENZO VISCONTI, Bsc
Organizational Affiliation
Studi Fisioterapici di Montagna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Studi fisioterapici di Montagna
City
Aosta
ZIP/Postal Code
11100
Country
Italy

12. IPD Sharing Statement

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Diathermy Compared With Sham Diathermy in Doms Management

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