NCT02367079

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

Same day

First QC Date

January 21, 2015

Last Update Submit

February 12, 2015

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

  • Numering pain rating scale

    Numering pain rating scale was assessed pre e post treatment

    Day 1

Study Arms (2)

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

DiathermyDEVICE

Sham diathermy vs switched on diathermy effect on pain where assessed

Switched OFF diathermySwitched on diathermy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Studi fisioterapici di Montagna

Aosta, Aosta, 11100, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Diathermy

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • LORENZO VISCONTI, Bsc

    Studi Fisioterapici di Montagna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 20, 2015

Study Start

April 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

IT(1)