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
About this trial
This is an interventional treatment trial for Musculoskeletal Diseases
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.
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
NCT ID
NCT02367079
First Posted
January 21, 2015
Last Updated
February 12, 2015
Sponsor
Studi Fisioterapici di Montagna
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
Learn more about this trial
Diathermy Compared With Sham Diathermy in Doms Management
We'll reach out to this number within 24 hrs