- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02693678
Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception
Real or Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS) in Skiers, Effect on Knee Joint Proprioception
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with DOMS after a skimountaineering race
Exclusion Criteria:
- Comorbidities, trauma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Massage
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
|
|
EXPERIMENTAL: Diathermy
10 min diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS
|
|
SHAM_COMPARATOR: Sham diathermy
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee joint proprioception
Time Frame: 30min post treatment
|
A video analysis of knee motion during a proprioception test will be done
|
30min post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient global impression of change (partecipants can determine if after receiving the treatment they feel to be improved or not on an nominal level)
Time Frame: 30min post treatment
|
A questionnaire will be submitted
|
30min post treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric pain rating scale (NPRS) (1 to 10 scale where 1 is the minor level of pain and 10 is the worst)
Time Frame: 30min post treatment
|
NPRS will be used
|
30min post treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lorenzo Visconti, Studi Fisioterapici di Montagna
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Studi FM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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