Anterior Knee Pain SyndromeNCT03620799
Efffectiveness of a Roller Intervention in Anterior Knee Pain
A study testing Manual therapy in people with Anterior Knee Pain Syndrome, run by Universidad de Granada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2018to 30 Sep 2018
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 65 years.
- Knee anterior pain diagnosis
Who cannot join
- Concomitant somatic or psychiatric disorder
- Previous knee surgery
- Other lower limb traumatological pathologies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the detailed description
Randomized controlled trial. patients were divided into two groups, intervention and control.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Manual therapy
- Keywords
- Roller intervention, Knee pain, Algometry
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyProcedure or surgery
A manual intervention technique is employed to the intervention group based on a roller treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes from baseline mechanosensitivity at 4 weeks
Secondary outcomes (4)
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion10 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee Pain SyndromeStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620799
- Sponsor's protocol ID
- DF0076UG
- Status last verified
- Jul 2018
- First submitted
- 24 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Roller Intervention in Patients With Anterior Knee Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03620799
- Acronym / sponsor ID
- DF0076UG
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Roller intervention, Knee pain, Algometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 10 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 8 Aug 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Manual therapy10 participants will be assigned to the intervention group in order to the inclusion criteria for the study. Experimental group. Manual therapy intervention |
| Control group | No intervention | –10 participants will be assigned to the control group in order to the inclusion criteria for the study. Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 65 years.
- Knee anterior pain diagnosis
Key exclusion criteria (3 listed)
- Concomitant somatic or psychiatric disorder
- Previous knee surgery
- Other lower limb traumatological pathologies
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 |
|---|---|---|
| Manual therapyA manual intervention technique is employed to the intervention group based on a roller treatment. | Procedure or surgery | Intervention group |
Primary outcome
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.
4 secondary outcomes
Vertical jump assessment with a mat
Time frame: Baseline, 4 weeks
Isokinetic strength
Time frame: Baseline, 4 weeks
Pain intensity assessed by the Brief Pain Inventory
Time frame: Baseline, 4 weeks
Functional knee limitation assessed by the Kujala Knee Score
Time frame: Baseline, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Anterior Knee Pain Syndrome, run by Universidad de Granada.
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 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958242360 ext. +34, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mechanosensitivity (time frame: Changes from baseline mechanosensitivity at 4 weeks). 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 8 Aug 2018.