NCT03620799

Brief Summary

Anterior knee pain is one of the most frequent reasons for consultation within knee conditions in adolescents and young adults. However, despite the high prevalence of this disorder, its pathogenesis and therefore its treatment are not clearly understood. Foam rolling has become a common intervention to enhance joint mobility and muscle recovery after exercise. the aim of this study is analyze the effectiveness of a roller intervention in patients with anterior knee pain.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

26 days

First QC Date

July 24, 2018

Last Update Submit

August 6, 2018

Conditions

Keywords

Roller interventionKnee painAlgometry

Outcome Measures

Primary Outcomes (1)

  • Changes in mechanosensitivity

    Mechanosensitivity is going to be assessed by a hand-held pressure algometer. The pressure will be applied perpendicular to the skin at a constant rate of 30 kPa/s until the patient felt the pressure change to pain and pressed a button defining the PPT.

    Changes from baseline mechanosensitivity at 4 weeks

Secondary Outcomes (4)

  • Vertical jump assessment with a mat

    Baseline, 4 weeks

  • Isokinetic strength

    Baseline, 4 weeks

  • Pain intensity assessed by the Brief Pain Inventory

    Baseline, 4 weeks

  • Functional knee limitation assessed by the Kujala Knee Score

    Baseline, 4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

10 participants will be assigned to the intervention group in order to the inclusion criteria for the study. Experimental group. Manual therapy intervention

Procedure: Manual therapy

Control group

NO INTERVENTION

10 participants will be assigned to the control group in order to the inclusion criteria for the study. Control group

Interventions

A manual intervention technique is employed to the intervention group based on a roller treatment.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 65 years.
  • Knee anterior pain diagnosis

You may not qualify if:

  • Concomitant somatic or psychiatric disorder
  • Previous knee surgery
  • Other lower limb traumatological pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Marie Carmen Valenza, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 8, 2018

Study Start

August 15, 2018

Primary Completion

September 10, 2018

Study Completion

September 30, 2018

Last Updated

August 8, 2018

Record last verified: 2018-07