NCT02693678

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

Same day

First QC Date

February 15, 2016

Last Update Submit

September 24, 2019

Conditions

Musculoskeletal Pain

Keywords

ProprioceptionDomsPainMassageDiathermy

Outcome Measures

Primary Outcomes (1)

  • Knee joint proprioception

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

    30min post treatment

Secondary Outcomes (1)

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

    30min post treatment

Other Outcomes (1)

  • Numeric pain rating scale (NPRS) (1 to 10 scale where 1 is the minor level of pain and 10 is the worst)

    30min post treatment

Study Arms (3)

Massage

EXPERIMENTAL

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

Other: Massage

Diathermy

EXPERIMENTAL

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

Device: DIathermy

Sham diathermy

SHAM COMPARATOR

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

Device: Sham diathermy

Interventions

MassageOTHER
Massage
DIathermyDEVICE
Diathermy
Sham diathermyDEVICE
Sham diathermy

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with DOMS after a skimountaineering race

You may not qualify if:

  • Comorbidities, trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 18390774BACKGROUND

  • 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.

    PMID: 26118518BACKGROUND

  • 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.

    PMID: 31956433DERIVED

MeSH Terms

Conditions

Musculoskeletal PainPainFever

Interventions

MassageDiathermy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBody Temperature Changes

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationHyperthermia, Induced

Study Officials

  • Lorenzo Visconti

    Studi Fisioterapici di Montagna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 29, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share