Patellofemoral Pain SyndromeNCT03051412
Pain Mechanisms in Young Adolescent Females With Longstanding Patellofemoral Pain
An observational study of Patellofemoral Pain Syndrome and Pain, run by Aalborg University at 1 site in Denmark.
Trial summary
Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females, which is associated with decreased quality of life and physical activity levels. PFP is highly persistent, with up to 50% of adolescents reporting persistent pain at both one and two year follow-ups. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome, Pain
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Feb 2017to 31 Aug 2017
- Phase
- Observational
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of young females. One group will include participants with current longstanding patellofemoral pain, while a second group will include those with a history of pain, who self report as recovered, and a control group, who has no previous history of knee pain.
Who may be able to join
- Female
- Age 18-30years
- Current longstanding patellofemoral pain
- Previous history of patellofemoral pain, reporting no current knee pain
- Female
- Aged 18-30 years
- Female
- Aged 18-30
Who cannot join
- Patients who have sustained a traumatic injury to the hip, knee, ankle or the lumbar spine within the past 3 month will be excluded.
- Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathy, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper) if they occur in isolation (without patellofemoral pain).
- Recovered Group:
- Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathi, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper)
- Other pain conditions
- Control:
- Current knee or other other musculoskeletal pain
- Previous history of knee or musculoskeletal pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Pain Sensitivity in Young Females With Longstanding Patellofemoral Pain, Recovered Females With a History of PFP, and Healthy Controls.
Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females, which is associated with decreased quality of life and physical activity levels. PFP is highly persistent, with up to 50% of adolescents reporting persistent pain at both one and two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older individuals with chronic pain, however, less is known about this in conditions such as PFP, which is common in younger populations. Additionally it is unknown if these characteristics return to similar values as healthy controls, when symptoms resolve.
The aim of this study will be to compare pain sensitivity in individuals with PFP, compared to those with a previous history of PFP who currently are pain-free, and a control group with no history of knee pain.
Read the detailed description
Recently it has been demonstrated that females with longstanding PFP demonstrate increased pain sensitivity, or hyperalgesia in the peripheral nervous system and impaired conditioned pain modulation, which is representative of decreased descending control of pain in the central nervous system. This is commonly seen in older adults with chronic longstanding pain, such as knee OA.
Understanding the evolution of pain mechanisms during recovery may yield important insights into the highly recurrent nature of this condition. Self-reported recovery appears to be associated with increased pressure pain thresholds, in comparison to those with current PFP. However, it is unknown whether these characteristics, along with centrally mediated pain processing, ever return to 'normal', or to the same levels of those with no history of pain.
To examine this, the investigation will compare the three groups (PFP versus Recovered versus Control), on measures of pain sensitivity (as defined in the primary and secondary outcomes), to determine differences between groups.
Demographic data, regarding age, height and weight will be collected, as well as pain frequency (almost daily, several times per week, weekly, monthly, rarely, never), pain intensity (measured on numeric rating scale), Knee Injury and Osteoarthritis Outcome score, and spatial distribution of pain (using the Navigate pain application). The group that self report as recovered, will be asked to report when their symptoms resolved.
A subgroup analysis will be undertaken in the recovered group, to examine the relationship between the time since last knee pain was experienced, (duration they self- report being symptom-free), and pain sensitivity, as assessed by the primary and secondary outcome measures.
Participants will be recruited from the Adolescent Pain in Aalborg (APA2011) cohort. In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically diagnosed with PFP. Five years later, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, completed a follow-up questionnaire regarding current pain (clinical trials.gov identifier: NCT02873143). From this group, a sample of participants' who were diagnosed with PFP in 2011, and self report with current pain, or as 'recovered' will be randomly contacted for inclusion in the current investigation (PFP and recovered groups respectively). Additionally, of the control participants from the original APA2011 cohort, who reported no pain in 2011, and no pain in 2016, a random sample will be drawn and invited to participate as the control group.
If this cohort is insufficient to reach the required sample size (n = 36 in each group), participants will be recruited through other sources such as GP's, and social media.
Embedded within this cross-sectional study, is a randomized crossover trial (in the group with PFP) which has been approved by the local ethical committee under the same approval number (N-20160058). This can be accessed on clinicaltrials.gov under the title "The acute effects of hip and knee exercises on pain sensitivity in young adult females with long-standing patellofemoral pain - a randomized crossover study." with Dr. Michael Rathleff as the primary investigator.
- Conditions
- Patellofemoral Pain Syndrome, Pain
- Being tested
- No Intervention
- Medical subject headings
- Patellofemoral Pain Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Current Patellofemoral Pain | This group has current patellofemoral pain Receives: Other: No Intervention | |
| Recovered | This group has a previous history of patellofemoral pain, but currently self reports as recovered. Receives: Other: No Intervention | |
| Control | This is a control group with no history of knee pain. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned pain modulation
Conditioned pain modulation (CPM) will be assessed using cuff algometry
Measured: Baseline
Secondary outcomes (4)
Pressure pain thresholds will be measured around the lower leg and forearm
Mechanical pressure pain thresholds will be assessed using a handheld algometer to assess distal and remote hyperalgesia.
Measured: baseline
Pressure Pain thresholds at the knee
Mechanical pressure pain thresholds will be assessed using a handheld algometer to assess local hyperalgesia.
Measured: baseline
Temporal summation of pain
Temporal summation is be induced by 10 short-lasting stimuli (1 sec each) at the level of PTT given with a 1 sec break in between stimuli using the cuff algometry. Subject will be instructed to rate the pain intensity after each stimulus using an electronic VAS scale.
Measured: baseline
Pressure detection & pressure tolerance threshold assessed by cuff algometry
Pressure detection \& tolerance thresholds will be assessed bilaterally on the lower extremity using cuff algometer.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start22 Feb 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice in Aalborg
- Responsible party
- Principal investigator, Sinead Holden, Aalborg University
- Investigators
- Sinead Holden, PhD, Principal investigator, Research Unit for General Practice, Department of Clinical Medicine, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051412
- Sponsor's protocol ID
- N-20160058 (1)
- Status last verified
- Nov 2017
- First submitted
- 9 Feb 2017
- Last updated
- 14 Nov 2017
- 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 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Pain Sensitivity in Young Females With Longstanding Patellofemoral Pain, Recovered Females With a History of PFP, and Healthy Controls.
- ClinicalTrials.gov ID
- NCT03051412
- Acronym / sponsor ID
- N-20160058 (1)
- Conditions
- Patellofemoral Pain Syndrome, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Research Unit for General Practice in Aalborg
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 13 Feb 2017 (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.
Patellofemoral pain (PFP) is a highly prevalent musculoskeletal condition in adult females, which is associated with decreased quality of life and physical activity levels. PFP is highly persistent, with up to 50% of adolescents reporting persistent pain at both one and two year follow-ups. Previous research has demonstrated altered pain sensitivity in in older individuals with chronic pain, however, less is known about this in conditions such as PFP, which is common in younger populations. Additionally it is unknown if these characteristics return to similar values as healthy controls, when symptoms resolve.
The aim of this study will be to compare pain sensitivity in individuals with PFP, compared to those with a previous history of PFP who currently are pain-free, and a control group with no history of knee pain.
Detailed description
Recently it has been demonstrated that females with longstanding PFP demonstrate increased pain sensitivity, or hyperalgesia in the peripheral nervous system and impaired conditioned pain modulation, which is representative of decreased descending control of pain in the central nervous system. This is commonly seen in older adults with chronic longstanding pain, such as knee OA.
Understanding the evolution of pain mechanisms during recovery may yield important insights into the highly recurrent nature of this condition. Self-reported recovery appears to be associated with increased pressure pain thresholds, in comparison to those with current PFP. However, it is unknown whether these characteristics, along with centrally mediated pain processing, ever return to 'normal', or to the same levels of those with no history of pain.
To examine this, the investigation will compare the three groups (PFP versus Recovered versus Control), on measures of pain sensitivity (as defined in the primary and secondary outcomes), to determine differences between groups.
Demographic data, regarding age, height and weight will be collected, as well as pain frequency (almost daily, several times per week, weekly, monthly, rarely, never), pain intensity (measured on numeric rating scale), Knee Injury and Osteoarthritis Outcome score, and spatial distribution of pain (using the Navigate pain application). The group that self report as recovered, will be asked to report when their symptoms resolved.
A subgroup analysis will be undertaken in the recovered group, to examine the relationship between the time since last knee pain was experienced, (duration they self- report being symptom-free), and pain sensitivity, as assessed by the primary and secondary outcome measures.
Participants will be recruited from the Adolescent Pain in Aalborg (APA2011) cohort. In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically diagnosed with PFP. Five years later, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, completed a follow-up questionnaire regarding current pain (clinical trials.gov identifier: NCT02873143). From this group, a sample of participants' who were diagnosed with PFP in 2011, and self report with current pain, or as 'recovered' will be randomly contacted for inclusion in the current investigation (PFP and recovered groups respectively). Additionally, of the control participants from the original APA2011 cohort, who reported no pain in 2011, and no pain in 2016, a random sample will be drawn and invited to participate as the control group.
If this cohort is insufficient to reach the required sample size (n = 36 in each group), participants will be recruited through other sources such as GP's, and social media.
Embedded within this cross-sectional study, is a randomized crossover trial (in the group with PFP) which has been approved by the local ethical committee under the same approval number (N-20160058). This can be accessed on clinicaltrials.gov under the title "The acute effects of hip and knee exercises on pain sensitivity in young adult females with long-standing patellofemoral pain - a randomized crossover study." with Dr. Michael Rathleff as the primary investigator.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current Patellofemoral Pain | – | Other: No InterventionThis group has current patellofemoral pain |
| Recovered | – | Other: No InterventionThis group has a previous history of patellofemoral pain, but currently self reports as recovered. |
| Control | – | Other: No InterventionThis is a control group with no history of knee pain. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of young females. One group will include participants with current longstanding patellofemoral pain, while a second group will include those with a history of pain, who self report as recovered, and a control group, who has no previous history of knee pain.
Key inclusion criteria (8 listed)
- Female
- Age 18-30years
- Current longstanding patellofemoral pain
- Previous history of patellofemoral pain, reporting no current knee pain
- Female
Key exclusion criteria (8 listed)
- Patients who have sustained a traumatic injury to the hip, knee, ankle or the lumbar spine within the past 3 month will be excluded.
- Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathy, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper) if they occur in isolation (without patellofemoral pain).
- Participants will be excluded if they have other diagnosable pathologies that can cause pain around the kneecap (patellatendinopathi, Osgood-Shlatter, iliotibial band syndrome, Sinding-Larsen-Johansson syndrome, reverse jumper)
- Other pain conditions
- Current knee or other other musculoskeletal pain
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 |
|---|---|---|
| No InterventionNo intervention | Other | Control, Current Patellofemoral Pain, Recovered |
Primary outcome
Conditioned pain modulation
Time frame: Baseline
Conditioned pain modulation (CPM) will be assessed using cuff algometry
4 secondary outcomes
Pressure pain thresholds will be measured around the lower leg and forearm
Time frame: baseline
Pressure Pain thresholds at the knee
Time frame: baseline
Temporal summation of pain
Time frame: baseline
Pressure detection & pressure tolerance threshold assessed by cuff algometry
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Sinead Holden, PhD principal investigator
Research Unit for General Practice, Department of Clinical Medicine, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome and Pain, run by Aalborg University at 1 site in Denmark.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned pain modulation (time frame: Baseline). 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 14 Nov 2017.