NCT03255525

Brief 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. Additionally, it is not known how the amount of pressure applied may influence pain mechanisms and, consequently how it affects the time needed promote an analgesic response. Having this, our general objective is to establish a dose-response relationship between the pressure applied during DFM and time of onset of analgesia, in the asymptomatic patellar tendon.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
Last Updated

August 21, 2017

Status Verified

August 1, 2017

Enrollment Period

21 days

First QC Date

August 18, 2017

Last Update Submit

August 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time until analgesia

    Self reported sensation of analgesia, controlled by a chronometer

    10 minutes

Study Arms (3)

Deep friction massage P50

ACTIVE COMPARATOR

In this group it was applied a pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.

Other: Deep friction massage P50

Deep friction massage P25

EXPERIMENTAL

In this group it was applied the percentile 25, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.

Other: Deep friction massage P25

Deep friction massage P75

EXPERIMENTAL

In this group it was applied the percentile 75, of the pressure previously found to be the mean pressure applied by physiotherapists during deep friction massage.

Other: Deep friction massage P75

Interventions

Deep friction massage as described by Dr. James Cyriax, applied with the mean pressure (P50)

Deep friction massage P50

Deep friction massage as described by Dr. James Cyriax, applied with the percentile 25 of the mean pressure (P25)

Deep friction massage P25

Deep friction massage as described by Dr. James Cyriax, applied with the percentile 75 of the mean pressure (P75)

Deep friction massage P75

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the participants should have an asymptomatic patellar tendon

You may not qualify if:

  • history of previous injury of the lower limbs;
  • intake of medication that could interfere with pain mechanisms;
  • presence of any factors or conditions that could interfere with the tendinous tissue as well as with the awareness and sensibility to pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooperativa Ensino Superior Politécnico e Universitário

Gandra, Paredes, 4585-116, Portugal

Location

Study Officials

  • Maria A Paço, PhD

    Cooperativa Ensino Superior Politécnico e Universitário

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical research

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 21, 2017

Study Start

July 26, 2017

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

August 21, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations