Acute Ankle DistortionNCT01249573
The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain
A study testing fascia therapy or transcutaneous fibrolysis in people with Acute Ankle Distortion, run by University Ghent at 1 site in Belgium.
Trial summary
This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Acute Ankle Distortion
- What is being tested?
- fascia therapy or transcutaneous fibrolysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to May 2011
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- acute ankle sprain
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.
This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.
Read the detailed description
Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.
In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.
The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.
- Conditions
- Acute Ankle Distortion
- Being tested
- fascia therapy or transcutaneous fibrolysis
- Keywords
- fascia therapy, transcutaneous fibrolysis, acute ankle distortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia therapy or transcutaneous fibrolysisOther
fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
| Study group | Role | What they receive |
|---|---|---|
| fascia therapy | Experimental | arm where fascia therapy is used as a treatment for an acute ankle distortion Receives: Other: fascia therapy or transcutaneous fibrolysis |
| transcutaneous fibrolysis | Experimental | arm where transcutaneous fibrolysis is used as a treatment for an acute ankle distortion Receives: Other: fascia therapy or transcutaneous fibrolysis |
| placebo | Placebo comparator | arm where placebo therapy is used as a treatment for an acute ankle distortion Receives: Other: fascia therapy or transcutaneous fibrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of fascia therapy
The effect of fascia therapy on an acute ankle distortion. Measurement of muscle power, muscle saturation, joint position sense, tenderness and disability questionnaires.
Measured: baseline measurements and within 1 hour after treatment
Secondary outcomes (1)
complaints registration
Self-assessed complaints registration.
Measured: baseline, 1 hour after treatment and 3 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ankle DistortionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Philip Roosen, Prof, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249573
- Sponsor's protocol ID
- EC/2010/580
- Status last verified
- Jun 2011
- First submitted
- 20 Oct 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.
- ClinicalTrials.gov ID
- NCT01249573
- Acronym / sponsor ID
- EC/2010/580
- Conditions
- Acute Ankle Distortion
- Keywords
- fascia therapy, transcutaneous fibrolysis, acute ankle distortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 30 Nov 2010 (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.
This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.
Detailed description
Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.
In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.
The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fascia therapy | Experimental | Other: fascia therapy or transcutaneous fibrolysisarm where fascia therapy is used as a treatment for an acute ankle distortion |
| transcutaneous fibrolysis | Experimental | Other: fascia therapy or transcutaneous fibrolysisarm where transcutaneous fibrolysis is used as a treatment for an acute ankle distortion |
| placebo | Placebo comparator | Other: fascia therapy or transcutaneous fibrolysisarm where placebo therapy is used as a treatment for an acute ankle distortion |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- acute ankle sprain
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| fascia therapy or transcutaneous fibrolysisfascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion | Other | fascia therapy, placebo, transcutaneous fibrolysis |
Primary outcome
effect of fascia therapy
Time frame: baseline measurements and within 1 hour after treatment
The effect of fascia therapy on an acute ankle distortion. Measurement of muscle power, muscle saturation, joint position sense, tenderness and disability questionnaires.
1 secondary outcome
complaints registration
Time frame: baseline, 1 hour after treatment and 3 days later
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 10 Jun 2011.
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.
Philip Roosen, Prof, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fascia therapy or transcutaneous fibrolysis in people with Acute Ankle Distortion, run by University Ghent at 1 site in Belgium.
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 10 Jun 2011. 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 Belgium. 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?
effect of fascia therapy (time frame: baseline measurements and within 1 hour after treatment). 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 10 Jun 2011.