Pain Mechanisms in Young Adolescent Females With Longstanding Patellofemoral Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03051412|
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : November 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Patellofemoral Pain Syndrome Pain||Other: No Intervention|
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 Type :||Observational|
|Actual Enrollment :||87 participants|
|Official Title:||Differences in Pain Sensitivity in Young Females With Longstanding Patellofemoral Pain, Recovered Females With a History of PFP, and Healthy Controls.|
|Actual Study Start Date :||February 22, 2017|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Current Patellofemoral Pain
This group has current patellofemoral pain
Other: No Intervention
This group has a previous history of patellofemoral pain, but currently self reports as recovered.
Other: No Intervention
This is a control group with no history of knee pain.
Other: No Intervention
- Conditioned pain modulation [ Time Frame: Baseline ]Conditioned pain modulation (CPM) will be assessed using cuff algometry
- Pressure pain thresholds will be measured around the lower leg and forearm [ Time Frame: baseline ]Mechanical pressure pain thresholds will be assessed using a handheld algometer to assess distal and remote hyperalgesia.
- Pressure Pain thresholds at the knee [ Time Frame: baseline ]Mechanical pressure pain thresholds will be assessed using a handheld algometer to assess local hyperalgesia.
- Temporal summation of pain [ Time Frame: baseline ]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.
- Pressure detection & pressure tolerance threshold assessed by cuff algometry [ Time Frame: baseline ]Pressure detection & tolerance thresholds will be assessed bilaterally on the lower extremity using cuff algometer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051412
|Research Unit for General Practice in Aalborg|
|Aalborg, Denmark, 9000|
|Principal Investigator:||Sinead Holden, PhD||Research Unit for General Practice, Department of Clinical Medicine, Aalborg University|