- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03620799
Efffectiveness of a Roller Intervention in Anterior Knee Pain
August 6, 2018 updated by: Marie Carmen Valenza, Universidad de Granada
Effectiveness of a Roller Intervention in Patients With Anterior Knee Pain: a Randomized Controlled Trial
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Randomized controlled trial.
patients were divided into two groups, intervention and control.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie Carmen Valenza, PhD
- Phone Number: +34 958242360
- Email: cvalenza@ugr.es
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients between 18 and 65 years.
- Knee anterior pain diagnosis
Exclusion Criteria:
- Concomitant somatic or psychiatric disorder
- Previous knee surgery
- Other lower limb traumatological pathologies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
10 participants will be assigned to the intervention group in order to the inclusion criteria for the study.
Experimental group.
Manual therapy intervention
|
A manual intervention technique is employed to the intervention group based on a roller treatment.
|
No Intervention: Control group
10 participants will be assigned to the control group in order to the inclusion criteria for the study.
Control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in mechanosensitivity
Time Frame: Changes from baseline mechanosensitivity at 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical jump assessment with a mat
Time Frame: Baseline, 4 weeks
|
The subject started with the foot of the designated testing leg on the contact mat and their hands on their hips, they were then instructed to sink and hold a knee position (approximately 1208 knee angle), and the experimenter then counted out 4 s.
On the count of four the subject was instructed to then jump as high as possible.
|
Baseline, 4 weeks
|
Isokinetic strength
Time Frame: Baseline, 4 weeks
|
Isokinetic strength of the knee flexors and extensors of each leg will be measured using an isokinetic Biodex dynamometer (Biodex Corporation, Shirley, NY), which recorded instantaneous muscular torques.
|
Baseline, 4 weeks
|
Pain intensity assessed by the Brief Pain Inventory
Time Frame: Baseline, 4 weeks
|
Pain will be assessed using the Brief Pain Inventory.
The Brief Pain Inventory is a pain assessment tool used to measure pain intensity and pain interference.
Patients rate the severity of their pain at its worst and least during the previous week, on average, and "right now".
Patients rate their level of pain interference in different contexts.
|
Baseline, 4 weeks
|
Functional knee limitation assessed by the Kujala Knee Score
Time Frame: Baseline, 4 weeks
|
The Kujala Knee Score questionnaire will be selected for self-reported functional activity level of the patients.
The composite score ranges from 0 to 100, with 100 indicating no functional limitation.
|
Baseline, 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 15, 2018
Primary Completion (Anticipated)
September 10, 2018
Study Completion (Anticipated)
September 30, 2018
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 6, 2018
First Posted (Actual)
August 8, 2018
Study Record Updates
Last Update Posted (Actual)
August 8, 2018
Last Update Submitted That Met QC Criteria
August 6, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0076UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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