Musculoskeletal PainNCT02693678
Real and Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS)Effect on Knee Proprioception
A study testing Massage and DIathermy in people with Musculoskeletal Pain, run by Studi Fisioterapici di Montagna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Massage and DIathermy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with DOMS after a skimountaineering race
Who cannot join
- Comorbidities, trauma
About this study
Official title: Real or Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS) in Skiers, Effect on Knee Joint Proprioception
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.
Read the 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Massage, DIathermy, Sham diathermy
- Keywords
- Proprioception, Doms, Pain, Massage, Diathermy
- Medical subject headings
- Musculoskeletal Pain, Pain, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
DIathermyDevice
Sham diathermyDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Sham diathermy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint proprioception
A video analysis of knee motion during a proprioception test will be done
Measured: 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)
A questionnaire will be submitted
Measured: 30min post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studi Fisioterapici di Montagna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland
- Responsible party
- Principal investigator, Lorenzo Visconti, Studi Fisioterapici di Montagna
- Investigators
- Lorenzo Visconti, Principal investigator, Studi Fisioterapici di Montagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693678
- Sponsor's protocol ID
- Studi FM
- Status last verified
- Sep 2019
- First submitted
- 15 Feb 2016
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 18390774Visconti 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.
PubMed 26118518Visconti 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.
PubMed 31956433
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real or Sham Diathermy vs Hand Massage in Lower Limbs Delayed Onset Muscle Soreness (DOMS) in Skiers, Effect on Knee Joint Proprioception
- ClinicalTrials.gov ID
- NCT02693678
- Acronym / sponsor ID
- Studi FM
- Conditions
- Musculoskeletal Pain
- Keywords
- Proprioception, Doms, Pain, Massage, Diathermy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Studi Fisioterapici di MontagnaUniversity, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Other: Massage10 min massage therapy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS |
| Diathermy | Experimental | Device: DIathermy10 min diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS |
| Sham diathermy | Sham comparator | Device: Sham diathermy10 min sham diathermy with neutral cream on lower limbs following the patients indications, the points need to be related to the presence of DOMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with DOMS after a skimountaineering race
Key exclusion criteria (1 listed)
- Comorbidities, trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage | Other | Massage |
| DIathermy | Device | Diathermy |
| Sham diathermy | Device | Sham diathermy |
Primary outcome
Knee joint proprioception
Time frame: 30min post treatment
A video analysis of knee motion during a proprioception test will be done
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 18390774Mir 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.
- Background: PubMed 26118518Visconti 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.
- Derived from this study: PubMed 31956433Visconti 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Visconti principal investigator
Studi Fisioterapici di Montagna
Questions about this trial
What is this clinical trial studying?
A study testing Massage and DIathermy in people with Musculoskeletal Pain, run by Studi Fisioterapici di Montagna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee joint proprioception (time frame: 30min post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02693678, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.