Musculoskeletal InjuryNCT01740661
Cryotherapy and Joint Biomechanics During Running
A study testing Cryotherapy in people with Musculoskeletal Injury, run by University of Calgary at 1 site in Canada.
Trial summary
The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Cryotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Jan 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males or females (18 - 40 yrs)
- no injuries of the lower extremity in the past 6 months prior to participation
- recreationally active
- in good health upon entry into the study
- willing to volunteer for the present project.
Who cannot join
- lower extremity injury within the last 6 months
- circulatory, vestibular or any contradiction to cryotherapy including Raynaud's disease
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Performance Laboratory, University of Calgary
Calgary, Alberta, T2N 1N4
About this study
Official title: Effects of Cryotherapy on Lower Extremity Joint Biomechanics During Running in Healthy Adults
The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running.
Read the detailed description
Cryotherapy or cold therapy has widely been used as a treatment modality in both acute and chronic injuries. It is believe that the application of cryotherapy can help to decrease pain, muscle soreness, soft tissue swelling, and cause vasoconstriction of blood vessels reducing heat loss. The nerve conduction velocity and muscle-spindle firing rate also decreases with cryotherapy, which results in changes in proprioception acuity. Cryotherapy has also been used prior to exercise (pre-cooling) to improve endurance activities. However, given the possible detrimental effects of cryotherapy on proprioception acuity, the use of this treatment modality prior to exercise could pose an increased risk of musculoskeletal injury. The effects of cryotherapy on lower extremity biomechanics during athletic movements is poorly understood despite the wide use among physiotherapists, athletic therapists and clinicians. Therefore, the purpose of this investigation is to determine the effects of cold water immersion on lower extremity biomechanics during running. The investigators hypothesize that cryotherapy as a form of treatment can increase the load in the lower extremity joint during gait biomechanics.
- Conditions
- Musculoskeletal Injury
- Being tested
- Cryotherapy, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyOther
The subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes.
ControlOther
The subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | The subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes. Receives: Other: Cryotherapy |
| Control | Placebo comparator | The subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee frontal plane moments
Knee frontal plane loading will be calculated using inverse dynamics based on the ground reaction force data from a force plate and with kinematic data recorded by high speed cameras. Kinematics and kinetics data will be taken during running at 4m/s from each participant prior and after the intervention.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudiane Fukuchi, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740661
- Sponsor's protocol ID
- IS-HPL-01
- Status last verified
- Jan 2013
- First submitted
- 20 Nov 2012
- Last updated
- 16 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cryotherapy on Lower Extremity Joint Biomechanics During Running in Healthy Adults
- ClinicalTrials.gov ID
- NCT01740661
- Acronym / sponsor ID
- IS-HPL-01
- Conditions
- Musculoskeletal Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Dec 2012 (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.
The purpose of this study is to determine the immediate effects of cryotherapy on the lower extremity biomechanics during running.
Detailed description
Cryotherapy or cold therapy has widely been used as a treatment modality in both acute and chronic injuries. It is believe that the application of cryotherapy can help to decrease pain, muscle soreness, soft tissue swelling, and cause vasoconstriction of blood vessels reducing heat loss. The nerve conduction velocity and muscle-spindle firing rate also decreases with cryotherapy, which results in changes in proprioception acuity. Cryotherapy has also been used prior to exercise (pre-cooling) to improve endurance activities. However, given the possible detrimental effects of cryotherapy on proprioception acuity, the use of this treatment modality prior to exercise could pose an increased risk of musculoskeletal injury. The effects of cryotherapy on lower extremity biomechanics during athletic movements is poorly understood despite the wide use among physiotherapists, athletic therapists and clinicians. Therefore, the purpose of this investigation is to determine the effects of cold water immersion on lower extremity biomechanics during running. The investigators hypothesize that cryotherapy as a form of treatment can increase the load in the lower extremity joint during gait biomechanics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: CryotherapyThe subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes. |
| Control | Placebo comparator | Other: ControlThe subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males or females (18 - 40 yrs)
- no injuries of the lower extremity in the past 6 months prior to participation
- recreationally active
- in good health upon entry into the study
- willing to volunteer for the present project.
Key exclusion criteria (2 listed)
- lower extremity injury within the last 6 months
- circulatory, vestibular or any contradiction to cryotherapy including Raynaud's disease
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 |
|---|---|---|
| CryotherapyThe subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes. | Other | Cryotherapy |
| ControlThe subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes. | Other | Control |
Primary outcome
Knee frontal plane moments
Time frame: 20 minutes
Knee frontal plane loading will be calculated using inverse dynamics based on the ground reaction force data from a force plate and with kinematic data recorded by high speed cameras. Kinematics and kinetics data will be taken during running at 4m/s from each participant prior and after the intervention.
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 16 Apr 2014.
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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 Cryotherapy in people with Musculoskeletal Injury, run by University of Calgary at 1 site in Canada.
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 5 inclusion and 2 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 16 Apr 2014. 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 Canada. 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. 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 frontal plane moments (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2014.