TendinopathyNCT03255538
Deep Friction Massage: Symptomatic
A study testing DFM: Mean pressure, DFM: Mean pressure - 25% and DFM: Mean pressure + 25% in people with Tendinopathy, run by Cooperativa de Ensino Superior, Politécnico e Universitário at 1 site in Portugal.
Trial summary
Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- DFM: Mean pressure, DFM: Mean pressure - 25% and DFM: Mean pressure + 25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 21 Aug 2017to 20 Nov 2017
- 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
- No healthy volunteers
- Adult
Who may be able to join
- The participants should have a symptomatic patellar tendon
Who cannot join
- History of other previous injuries of the lower limbs;
- Intake of medication that could interfere with pain mechanisms;
- Presence of any factors or conditions that could interfere with the awareness and sensibility to pain.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Cooperativa Ensino Superior Politécnico e Universitário
Gandra, Paredes, 4585-116
About this study
Official title: Deep Friction Massage Effects on Pain and Function in Patellar Tendinopathy
Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms or function in the symptomatic patellar tendon. Having this, our objective is to characterize the pressure applied during deep friction massage and evaluate the immediate effects of different pressures applied during deep friction massage in the time until analgesia as well as in function, in patellar tendinopathy.
- Conditions
- Tendinopathy
- Being tested
- DFM: Mean pressure, DFM: Mean pressure - 25%, DFM: Mean pressure + 25%
- Keywords
- patellar tendon
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFM: Mean pressureOther
Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment.
DFM: Mean pressure - 25%Other
Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment decremented by 25%.
DFM: Mean pressure + 25%Other
Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment incremented by 25%.
| Study group | Role | What they receive |
|---|---|---|
| DFM: Mean pressure | Experimental | In this group, deep friction massage will be applied with the mean pressure, previously obtained in a baseline assessment. Receives: Other: DFM: Mean pressure |
| DFM: Mean pressure - 25% | Experimental | In this group, deep friction massage will be applied will less 25% of the pressure previously obtained in a baseline assessment. Receives: Other: DFM: Mean pressure - 25% |
| DFM: Mean pressure +25% | Experimental | In this group, deep friction massage will be applied will an increment of 25% of the pressure previously obtained in a baseline assessment. Receives: Other: DFM: Mean pressure + 25% |
| Control session | No intervention | In this group, the participants will rest for 15 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until analgesia
Time until self reported sensation of analgesia, controlled by a chronometer, since the application of deep friction massage.
Measured: 10 minutes
Numeric Pain Rating Scale
Self-reported pain intensity.
Measured: 20 minutes
Maximal isometric strength of quadriceps
Measure of maximal isometric strength, through a dynamometer.
Measured: 20 minutes
Knee flexion range of movement
Measure of knee flexion range of movement, through a goniometer
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 posted21 Aug 2017
- Study start21 Aug 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e Universitário
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Paço, Cooperativa de Ensino Superior, Politécnico e Universitário
- Investigators
- Maria A Paço, PhD, Principal investigator, Cooperativa Ensino Superior Politécnico e Universitário
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255538
- Sponsor's protocol ID
- DFM_2
- Status last verified
- Mar 2018
- First submitted
- 18 Aug 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Friction Massage Effects on Pain and Function in Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT03255538
- Acronym / sponsor ID
- DFM_2
- Conditions
- Tendinopathy
- Keywords
- patellar tendon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cooperativa de Ensino Superior, Politécnico e UniversitárioUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
Despite DFM being a widely-used technique and the empirical grounding regarding the importance of the pressure applied, there is no study characterizing the pressure applied during DFM, remaining it a discretion of the physiotherapist. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms or function in the symptomatic patellar tendon. Having this, our objective is to characterize the pressure applied during deep friction massage and evaluate the immediate effects of different pressures applied during deep friction massage in the time until analgesia as well as in function, in patellar tendinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DFM: Mean pressure | Experimental | Other: DFM: Mean pressureIn this group, deep friction massage will be applied with the mean pressure, previously obtained in a baseline assessment. |
| DFM: Mean pressure - 25% | Experimental | Other: DFM: Mean pressure - 25%In this group, deep friction massage will be applied will less 25% of the pressure previously obtained in a baseline assessment. |
| DFM: Mean pressure +25% | Experimental | Other: DFM: Mean pressure + 25%In this group, deep friction massage will be applied will an increment of 25% of the pressure previously obtained in a baseline assessment. |
| Control session | No intervention | –In this group, the participants will rest for 15 minutes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The participants should have a symptomatic patellar tendon
Key exclusion criteria (3 listed)
- History of other previous injuries of the lower limbs;
- Intake of medication that could interfere with pain mechanisms;
- Presence of any factors or conditions that could interfere with the awareness and sensibility to pain.
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 |
|---|---|---|
| DFM: Mean pressureDeep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment. | Other | DFM: Mean pressure |
| DFM: Mean pressure - 25%Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment decremented by 25%. | Other | DFM: Mean pressure - 25% |
| DFM: Mean pressure + 25%Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment incremented by 25%. | Other | DFM: Mean pressure +25% |
Primary outcome
Time until analgesia
Time frame: 10 minutes
Time until self reported sensation of analgesia, controlled by a chronometer, since the application of deep friction massage.
Numeric Pain Rating Scale
Time frame: 20 minutes
Self-reported pain intensity.
Maximal isometric strength of quadriceps
Time frame: 20 minutes
Measure of maximal isometric strength, through a dynamometer.
Knee flexion range of movement
Time frame: 20 minutes
Measure of knee flexion range of movement, through a goniometer
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 7 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Maria A Paço, PhD principal investigator
Cooperativa Ensino Superior Politécnico e Universitário
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFM: Mean pressure, DFM: Mean pressure - 25% and DFM: Mean pressure + 25% in people with Tendinopathy, run by Cooperativa de Ensino Superior, Politécnico e Universitário at 1 site in Portugal.
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 3 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 7 Mar 2018. 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 Portugal. 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?
Time until analgesia (time frame: 10 minutes). The study lists 4 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 7 Mar 2018.