Delayed Onset Muscle SorenessNCT02018211
Neuromuscular Electrical Stimulation Via the Peroneal Nerve Reduces Muscle Soreness Following Intermittent Exercise
A study testing graduated compression socks and neuromuscular electrical stimulation device in people with Delayed Onset Muscle Soreness, run by Firstkind Ltd at 1 site in United Kingdom.
Trial summary
Numerous techniques are reported to enhance recovery following intense exercise, however there is equivocal support for such claims. A novel technique of neuromuscular electrical stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which could enhance recovery following exercise. Read more about this study
- Who is it for?
- Ages 20 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- graduated compression socks and neuromuscular electrical stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Mar 2013
- 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 20 to 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- currently playing intermittent sports (such as soccer, field hockey, rugby)
- currently representing their respective sports at either university, county, national or international levels
Who cannot join
- unhealthy males
- not currently playing intermittent sports (such as soccer, field hockey, rugby)
- not currently representing their respective sports at either university, county, national or international levels
- individuals indicating a history of cardiovascular, metabolic or haematological disorders
- participants reporting a sedentary lifestyle of less than three 30-min physical activity sessions per week
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Exercise and Health Sciences
Loughborough, Leicestershire, LE11 3TU
About this study
Numerous techniques are reported to enhance recovery following intense exercise, however there is equivocal support for such claims. A novel technique of neuromuscular electrical stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which could enhance recovery following exercise. The present study examined the effects of NMES, compared to graduated compression socks on muscle soreness, strength, and markers of muscle damage and inflammation following intense intermittent exercise.
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- control, graduated compression socks, neuromuscular electrical stimulation device
- Keywords
- delayed onset muscle soreness, muscle damage, muscle function, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlOther
passive recovery following exercise test
graduated compression socksDevice
graduated compression socks worn after test exercise
neuromuscular electrical stimulation deviceDevice
Also called firefly device
neuromuscular electrical stimulation device worn after test exercise
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | All participants performed a modified version of the Loughborough Intermittent Shuttle Test (LIST; Nicholas et al, 2000), an exercise protocol designed to simulate the activity pattern characteristics of intermittent sports such as soccer. The LIST was performed on three occasions, at the same time of day, each separated by approximately four weeks. Following each exercise trial, one of three recovery interventions were applied, the order of which were randomly allocated. Receives: Other: control; Device: graduated compression socks; Device: neuromuscular electrical stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived muscle soreness (PMS)
perceived muscle soreness (PMS), often referred to as delayed onset muscle soreness (DOMS)
Measured: 72hrs
Secondary outcomes (1)
muscle strength
Measured: 72hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Onset Muscle SorenessStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Loughborough University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018211
- Sponsor's protocol ID
- FK-Sport-001
- Other IDs
- Loughborough
- Status last verified
- Jun 2015
- First submitted
- 17 Dec 2013
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferguson RA, Dodd MJ, Paley VR. Neuromuscular electrical stimulation via the peroneal nerve is superior to graduated compression socks in reducing perceived muscle soreness following intense intermittent endurance exercise. Eur J Appl Physiol. 2014 Oct;114(10):2223-32. doi: 10.1007/s00421-014-2943-5. Epub 2014 Jul 11.
PubMed 25011496
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation Via the Peroneal Nerve Reduces Muscle Soreness Following Intermittent Exercise
- ClinicalTrials.gov ID
- NCT02018211
- Acronym / sponsor ID
- FK-Sport-001
- Conditions
- Delayed Onset Muscle Soreness
- Keywords
- delayed onset muscle soreness, muscle damage, muscle function, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Collaborators
- Loughborough University
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Dec 2013 (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.
Numerous techniques are reported to enhance recovery following intense exercise, however there is equivocal support for such claims. A novel technique of neuromuscular electrical stimulation (NMES) via the peroneal nerve has been shown to augment limb blood flow which could enhance recovery following exercise. The present study examined the effects of NMES, compared to graduated compression socks on muscle soreness, strength, and markers of muscle damage and inflammation following intense intermittent exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: control, Device: graduated compression socks, Device: neuromuscular electrical stimulation deviceAll participants performed a modified version of the Loughborough Intermittent Shuttle Test (LIST; Nicholas et al, 2000), an exercise protocol designed to simulate the activity pattern characteristics of intermittent sports such as soccer. The LIST was performed on three occasions, at the same time of day, each separated by approximately four weeks. Following each exercise trial, one of three recovery interventions were applied, the order of which were randomly allocated. |
Who may qualify
- Ages
- 20 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy males
- currently playing intermittent sports (such as soccer, field hockey, rugby)
- currently representing their respective sports at either university, county, national or international levels
Key exclusion criteria (5 listed)
- unhealthy males
- not currently playing intermittent sports (such as soccer, field hockey, rugby)
- not currently representing their respective sports at either university, county, national or international levels
- individuals indicating a history of cardiovascular, metabolic or haematological disorders
- participants reporting a sedentary lifestyle of less than three 30-min physical activity sessions per week
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 |
|---|---|---|
| controlpassive recovery following exercise test | Other | experimental group |
| graduated compression socksgraduated compression socks worn after test exercise | Device | experimental group |
| neuromuscular electrical stimulation deviceAlso: firefly deviceneuromuscular electrical stimulation device worn after test exercise | Device | experimental group |
Primary outcome
Perceived muscle soreness (PMS)
Time frame: 72hrs
perceived muscle soreness (PMS), often referred to as delayed onset muscle soreness (DOMS)
1 secondary outcome
muscle strength
Time frame: 72hrs
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 Jun 2015.
- Results publication: PubMed 25011496Ferguson RA, Dodd MJ, Paley VR. Neuromuscular electrical stimulation via the peroneal nerve is superior to graduated compression socks in reducing perceived muscle soreness following intense intermittent endurance exercise. Eur J Appl Physiol. 2014 Oct;114(10):2223-32. doi: 10.1007/s00421-014-2943-5. Epub 2014 Jul 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graduated compression socks and neuromuscular electrical stimulation device in people with Delayed Onset Muscle Soreness, run by Firstkind Ltd at 1 site in United Kingdom.
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 3 inclusion and 5 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 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Perceived muscle soreness (PMS) (time frame: 72hrs). 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 NCT02018211, which also lists 1 linked publication.
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 Jun 2015.