Healthy SituationFrictionNCT01453543
The Effect of Deep Friction Massage on the Achilles Tendon Blood Flow
A study testing deep transverse friction massage in people with Healthy Situation, run by University Ghent at 1 site in Belgium.
Trial summary
Background: There is a hypothesis in literature that the mechanical action of deep transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Situation
- What is being tested?
- deep transverse friction massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- a history of lower leg injury
- systematic disease
- persons using drugs
- subjects with circulatory disorders or cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Background: There is a hypothesis in literature that the mechanical action of deep transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon. Objective: The purpose of the present study was to investigate whether one session of DTF can influence the Achilles tendon blood flow.
Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants volunteered. Each person underwent the following four steps of the procedure: 1. Measuring the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).
Intervention: one leg of each person was randomly assigned to deep transverse friction session, the other leg was used as a control leg. Friction was applied continuously for a total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue depths at the distal and the proximal midportion of the Achilles tendon. For each level, the capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling pressure was registered.
- Conditions
- Healthy Situation
- Being tested
- deep transverse friction massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep transverse friction massageOther
For the application of the deep transverse friction massage, the participants were positioned supine with the ankle in 90 ° of dorsiflexion, in order to bring some tension on the tendon. The treating clinician stabilized the subject's foot with one hand while applying the DTF with the other hand. The deep friction massage is a pinching technique with thumb and index finger, reinforced by the middle finger.
| Study group | Role | What they receive |
|---|---|---|
| Deep transverse friction massage | Experimental | Massage technique will be used. Receives: Other: deep transverse friction massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow of the Achilles tendon
Blood flow of the Achilles tendon will be measured with the oxygen-to-see.
Measured: after 15 minutes of friction
Blood flow of the Achilles tendon
Blood flow of the Achilles tendon will be measured with the oxygen-to-see.
Measured: After 20 minutes of rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SituationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453543
- Sponsor's protocol ID
- 2010/460
- Acronym
- Friction
- Status last verified
- Nov 2011
- First submitted
- 12 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Friction Massage on the Achilles Tendon Blood Flow
- ClinicalTrials.gov ID
- NCT01453543
- Acronym / sponsor ID
- Friction / 2010/460
- Conditions
- Healthy Situation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Oct 2011 (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.
Background: There is a hypothesis in literature that the mechanical action of deep transverse friction massage (DTF) produces vasodilatation and increases blood flow. But as yet, no experimental study has confirmed the effect of DTF on blood flow in the Achilles tendon. Objective: The purpose of the present study was to investigate whether one session of DTF can influence the Achilles tendon blood flow.
Design: a randomized pre- posttest trial was set up. Patients: Sixty-two healthy participants volunteered. Each person underwent the following four steps of the procedure: 1. Measuring the tendon blood flow (PRE), 2.fifteen minutes of DTF on the Achilles tendon, 3. Measuring of the tendon blood flow (POST), 4.follow - up measurement after 20 minutes of rest (POST20).
Intervention: one leg of each person was randomly assigned to deep transverse friction session, the other leg was used as a control leg. Friction was applied continuously for a total of 15 minutes. Measurements: the microcirculation was determined at 2 and 8 tissue depths at the distal and the proximal midportion of the Achilles tendon. For each level, the capillary blood flow, the tissue oxygen saturation, and the postcapillary venous filling pressure was registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep transverse friction massage | Experimental | Other: deep transverse friction massageMassage technique will be used. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- a history of lower leg injury
- systematic disease
- persons using drugs
- subjects with circulatory disorders or cardiovascular diseases
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 |
|---|---|---|
| deep transverse friction massageFor the application of the deep transverse friction massage, the participants were positioned supine with the ankle in 90 ° of dorsiflexion, in order to bring some tension on the tendon. The treating clinician stabilized the subject's foot with one hand while applying the DTF with the other hand. The deep friction massage is a pinching technique with thumb and index finger, reinforced by the middle finger. | Other | Deep transverse friction massage |
Primary outcome
Blood flow of the Achilles tendon
Time frame: after 15 minutes of friction
Blood flow of the Achilles tendon will be measured with the oxygen-to-see.
Blood flow of the Achilles tendon
Time frame: After 20 minutes of rest.
Blood flow of the Achilles tendon will be measured with the oxygen-to-see.
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 8 Nov 2011.
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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.
Erik Witvrouw, MD, 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 deep transverse friction massage in people with Healthy Situation, 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 0 inclusion and 4 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 8 Nov 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. 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?
Blood flow of the Achilles tendon (time frame: after 15 minutes of friction). The study lists 2 primary outcomes in all. 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 8 Nov 2011.