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Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Massage
DIathermy
Sham 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 Pain focused on measuring Proprioception, Doms, Pain, Massage, Diathermy

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with DOMS after a skimountaineering race

Exclusion Criteria:

  • Comorbidities, trauma

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    Massage

    Diathermy

    Sham diathermy

    Arm Description

    10 min massage therapy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS

    10 min diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS

    10 min sham diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS

    Outcomes

    Primary Outcome Measures

    Knee joint proprioception
    A video analysis of knee motion during a proprioception test will be done

    Secondary Outcome Measures

    Patient global impression of change (partecipants can determine if after receiving the treatment they feel to be improved or not on an nominal level)
    A questionnaire will be submitted

    Full Information

    First Posted
    February 15, 2016
    Last Updated
    September 24, 2019
    Sponsor
    Studi Fisioterapici di Montagna
    Collaborators
    University of Applied Sciences and Arts of Southern Switzerland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02693678
    Brief Title
    Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception
    Official Title
    Real or Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS) in Skiers, Effect on Knee Joint Proprioception
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Studi Fisioterapici di Montagna
    Collaborators
    University of Applied Sciences and Arts of Southern Switzerland

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint . The study aim is to assess the effect of manual massage, diathermy and sham diathermy the proprioception of the knee joint in patients affected by DOMS.
    Detailed Description
    Delayed onset muscle soreness (DOMS) can have an impact on the proprioception of knee joint. The study aim is to assess the effect of manual massage, diathermy and sham diathermy on the proprioception of the knee joint in patients affected by DOMS. Proprioception will be measured with "Technique" an App available on appstore , on the basis of the work on knee proprioception by S M Mir 2008 , and data about pain with numbering pain rating scale (NPRS) and pre-post treatment and global impression of change (PGIC) will be acquired.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Musculoskeletal Pain
    Keywords
    Proprioception, Doms, Pain, Massage, Diathermy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Massage
    Arm Type
    Experimental
    Arm Description
    10 min massage therapy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS
    Arm Title
    Diathermy
    Arm Type
    Experimental
    Arm Description
    10 min diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS
    Arm Title
    Sham diathermy
    Arm Type
    Sham Comparator
    Arm Description
    10 min sham diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS
    Intervention Type
    Other
    Intervention Name(s)
    Massage
    Intervention Type
    Device
    Intervention Name(s)
    DIathermy
    Intervention Type
    Device
    Intervention Name(s)
    Sham diathermy
    Primary Outcome Measure Information:
    Title
    Knee joint proprioception
    Description
    A video analysis of knee motion during a proprioception test will be done
    Time Frame
    30min post treatment
    Secondary Outcome Measure Information:
    Title
    Patient global impression of change (partecipants can determine if after receiving the treatment they feel to be improved or not on an nominal level)
    Description
    A questionnaire will be submitted
    Time Frame
    30min post treatment
    Other Pre-specified Outcome Measures:
    Title
    Numeric pain rating scale (NPRS) (1 to 10 scale where 1 is the minor level of pain and 10 is the worst)
    Description
    NPRS will be used
    Time Frame
    30min post treatment

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with DOMS after a skimountaineering race Exclusion Criteria: Comorbidities, trauma
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lorenzo Visconti
    Organizational Affiliation
    Studi Fisioterapici di Montagna
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    18390774
    Citation
    Mir SM, Hadian MR, Talebian S, Nasseri N. Functional assessment of knee joint position sense following anterior cruciate ligament reconstruction. Br J Sports Med. 2008 Apr;42(4):300-3. doi: 10.1136/bjsm.2007.044875.
    Results Reference
    background
    PubMed Identifier
    26118518
    Citation
    Visconti L, Capra G, Carta G, Forni C, Janin D. Effect of massage on DOMS in ultramarathon runners: A pilot study. J Bodyw Mov Ther. 2015 Jul;19(3):458-63. doi: 10.1016/j.jbmt.2014.11.008. Epub 2014 Nov 24.
    Results Reference
    background
    PubMed Identifier
    31956433
    Citation
    Visconti L, Forni C, Coser R, Trucco M, Magnano E, Capra G. Comparison of the effectiveness of manual massage, long-wave diathermy, and sham long-wave diathermy for the management of delayed-onset muscle soreness: a randomized controlled trial. Arch Physiother. 2020 Jan 15;10:1. doi: 10.1186/s40945-019-0073-4. eCollection 2020.
    Results Reference
    derived

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    Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception

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