Back to resultsEfffectiveness of a Roller Intervention in Anterior Knee Pain
Primary Purpose
Anterior Knee Pain Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual therapy
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Knee Pain Syndrome focused on measuring Roller intervention, Knee pain, Algometry
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
10 participants will be assigned to the intervention group in order to the inclusion criteria for the study. Experimental group. Manual therapy intervention
10 participants will be assigned to the control group in order to the inclusion criteria for the study. Control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Vertical jump assessment with a mat
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.
Isokinetic strength
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.
Pain intensity assessed by the Brief Pain Inventory
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.
Functional knee limitation assessed by the Kujala Knee Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03620799
Brief Title
Efffectiveness of a Roller Intervention in Anterior Knee Pain
Official Title
Effectiveness of a Roller Intervention in Patients With Anterior Knee Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Anticipated)
Primary Completion Date
September 10, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Randomized controlled trial. patients were divided into two groups, intervention and control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Knee Pain Syndrome
Keywords
Roller intervention, Knee pain, Algometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
10 participants will be assigned to the intervention group in order to the inclusion criteria for the study. Experimental group. Manual therapy intervention
Arm Title
Control group
Arm Type
No Intervention
Arm Description
10 participants will be assigned to the control group in order to the inclusion criteria for the study. Control group
Intervention Type
Procedure
Intervention Name(s)
Manual therapy
Intervention Description
A manual intervention technique is employed to the intervention group based on a roller treatment.
Primary Outcome Measure Information:
Title
Changes in mechanosensitivity
Description
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.
Time Frame
Changes from baseline mechanosensitivity at 4 weeks
Secondary Outcome Measure Information:
Title
Vertical jump assessment with a mat
Description
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.
Time Frame
Baseline, 4 weeks
Title
Isokinetic strength
Description
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.
Time Frame
Baseline, 4 weeks
Title
Pain intensity assessed by the Brief Pain Inventory
Description
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.
Time Frame
Baseline, 4 weeks
Title
Functional knee limitation assessed by the Kujala Knee Score
Description
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.
Time Frame
Baseline, 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Ext
+34
Email
cvalenza@ugr.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efffectiveness of a Roller Intervention in Anterior Knee Pain
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