Knee CapNCT03784339
Effect of Designated Education Session on Patellofemoral Pain
A study testing Physiotherapy + education and Physiotherapy in people with Knee Cap, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
Feasibility study: Does a designated education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site feasibility Study Aim: Aims are to identify if a formal education session (intervention) improves patient outcomes and to assess if it is… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Cap
- What is being tested?
- Physiotherapy + education and Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Mar 2019to 29 Nov 2019
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-40
- Be able to understand and converse in English
- Clinical diagnosis of PFPS
- Be able to attend for up-to 12 weeks of physiotherapy
Who cannot join
- Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side.
- A diagnosis of PFJ osteoarthritis as confirmed by X-Ray or MRI.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Liverpool & Broadgreen University Hospitals Trust
Liverpool, Merseyside
About this study
Official title: Feasibility Study: Does a Designated Education Session Change Levels of Catastrophizing, Kinesiophobia and Pain Beliefs in Patients With Patellofemoral Pain?
Feasibility study: Does a designated education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site feasibility Study Aim: Aims are to identify if a formal education session (intervention) improves patient outcomes and to assess if it is possible to test the intervention for efficacy in a larger study.
Outcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or OA.
Read more
Secondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for Kinesiophobia.
Patients who are eligible for inclusion in the study will be identified from the Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band 8 Physiotherapist the South Liverpool Treatment Centre.
Intervention: The intervention will comprise a 1:1, 30 minute education session delivered by a specialist musculoskeletal physiotherapist with over ten years' experience who has an interest in patellofemoral pain.
The education session will be based on a schedule formed from the most recent research on patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus is a word used to describe any grinding, creaking, cracking, grating, crunching or popping that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence of others will be discussed.
The intervention will be supported by the leaflet 'managing my patellofemoral pain' developed by Barton and Rathleff (2016) on the basis of international opinion from 21 international experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.
Duration: Within the time constraints of a Masters Degree, patients will be recruited over a four month period. There will be four months for follow up and a further four months for write up, total study duration 12 months.
Read the detailed description
Design: A feasibility study to assess if a physiotherapy education session in addition to standard care improves patients scores regarding catastrophizing and kinesiophobia when measured by KOOS-PF, Pain Catastrophizing Scale and Tampa Scale
Objectives:
- To assess if providing a specific education session which reviews patients beliefs about crepitus, causes of pain, joint mechanics and purpose of exercise has an effect on catastrophizing and kinesiophobia.
- To identify if the study is feasible on a larger scale, which would allow the intervention to be assessed for efficacy. If a future study was able to demonstrate that the intervention was effective this would provide an additional evidence based intervention for use in clinical practice.
Recruitment: NHS patients diagnosed in a Musculoskeletal Clinical Assessment Service [MCAS] with patellofemoral pain at the South Liverpool Treatment Centre.
Inclusion criteria:
- Adults aged 18-40
- Be able to understand and converse in English
- Clinical diagnosis of PFP
- Be able to attend for up-to 12 weeks of physiotherapy
Exclusion criteria:
- Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side.
- A diagnosis of patellofemoral joint (PFJ) OA as confirmed by X-Ray or Magnetic Resonance Imaging (MRI).
Sample size: There is limited published research regarding the use of the questionnaire KOOS-PF in research. As a result it is not possible to do a definitive study to test whether or not the education session effects patient outcome. Therefore it is necessary to do a feasibility study with a small sample size of 24 patients (control n=12, intervention n=12) which will allow any change in the questionnaire scores to be used to calculate how many patients would be needed for a definitive study which would allow researchers to assess whether or not the exercise intervention affected patient outcome, which could improve patient care. The research team are confident that the required number of patients could be recruited as audit data from the service identified that 104 patients in the MCAS service met the criteria for inclusion in this proposed study.
Baseline measures: Participants' characteristics including age, gender and duration of symptoms will be collected alongside baseline measures for the chosen questionnaires - the KOOS-PF, Tampa-scale for Kinesiophobia and Pain Catastrophizing. These questionnaires will be repeated at 12 weeks.
Intervention: Patients recruited into the study will be randomised to either the intervention (n=12) or the control group (n=12). Participants in the control group will undergo standard treatment.
The intervention: Participants in the intervention group will receive standard treatment plus the education session.
The education session will be based on a leaflet produced by other leading researchers in the field and will also explore the causes of pain, beliefs about pain, beliefs about noise that come from the joint, the impact of the pain on activity and the influence of other family members' experience and beliefs about knee pain. At 12 weeks, participants from both groups will be asked to repeat the questionnaires.
Statistical analysis: Descriptive statistical analysis will be performed on the data and the lead researcher will work with the statistics department at MMU to review the change in the chosen questionnaires to identify the sample size required for a definitive study which will assess how effective the education session is on patients' symptoms of PFP.
- Conditions
- Knee Cap
- Being tested
- Physiotherapy + education, Physiotherapy
- Keywords
- Patellofemoral, Knee
- Medical subject headings
- Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy + educationOther
Participants will take part in a 30 minute education session surrounding fear of movement and catastrophizing thoughts. They will then receive standard care, which will involve strength exercises and taping if needed.
PhysiotherapyOther
Standard physiotherapy care
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Placebo comparator | Participants will receive standard physiotherapy care, which will involve strength exercises and taping. Receives: Other: Physiotherapy |
| Physiotherapy + education | Experimental | Physiotherapy + education Standard physiotherapy care plus 30 minute education session addressing fear of movement and catastrophizing thoughts. Receives: Other: Physiotherapy + education; Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)
The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.
Measured: 12 weeks following baseline visit
Secondary outcomes (2)
Tampa Scale for Kinesiophobia (TSK)
The TSK is a 17-item patient reported outcome measure of fear of movement. A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.
Measured: 12 weeks following baseline visit
Pain Catastrophizing Scale (PCS)
The PCS is a 13 item patient reported outcome measure where the PCS total score is computed by summing the responses to all 13 items. PCS total scores range from 0 - 52, with higher scores indicating greater pain catastrophizing
Measured: 12 weeks following baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start2 Mar 2019
- Primary completion13 Aug 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee CapStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Selfe, DSc, Manchester Metropolitan University
- Investigators
- James Selfe, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784339
- Sponsor's protocol ID
- PatellofemoralPain_DEC2018
- Status last verified
- Feb 2020
- First submitted
- 19 Dec 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study: Does a Designated Education Session Change Levels of Catastrophizing, Kinesiophobia and Pain Beliefs in Patients With Patellofemoral Pain?
- ClinicalTrials.gov ID
- NCT03784339
- Acronym / sponsor ID
- PatellofemoralPain_DEC2018
- Conditions
- Knee Cap
- Keywords
- Patellofemoral, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 13 Aug 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 21 Dec 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.
Feasibility study: Does a designated education session change levels of catastrophizing, kinesiophobia and pain beliefs in patients with patellofemoral pain? Design: Single site feasibility Study Aim: Aims are to identify if a formal education session (intervention) improves patient outcomes and to assess if it is possible to test the intervention for efficacy in a larger study.
Outcome Measures: The primary outcome measure is the Knee Osteoarthritis Outcome Score-Patellofemoral) KOOS-PF. The original KOOS consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of Life (QOL). The KOOS-PF was developed to evaluate individuals or samples of individuals who present with anterior knee pain/patellofemoral pain and/or patellofemoral osteoarthritis (OA), or who are at risk of developing patellofemoral pain or OA.
Secondary Outcome Measures are Pain Catastrophizing Scale and The Tampa Scale for Kinesiophobia.
Patients who are eligible for inclusion in the study will be identified from the Musculoskeletal Clinical Assessment Service (MCAS) by Band 6's and 7's and approved by a Band 8 Physiotherapist the South Liverpool Treatment Centre.
Intervention: The intervention will comprise a 1:1, 30 minute education session delivered by a specialist musculoskeletal physiotherapist with over ten years' experience who has an interest in patellofemoral pain.
The education session will be based on a schedule formed from the most recent research on patellofemoral pain PFP which considers psychosocial factors (Robertson et al 2017). Crepitus is a word used to describe any grinding, creaking, cracking, grating, crunching or popping that occurs when the patellofemoral joint moves (Robertson et al 2017). The psychological factors, specifically patients' beliefs about crepitus, avoiding crepitus and the influence of others will be discussed.
The intervention will be supported by the leaflet 'managing my patellofemoral pain' developed by Barton and Rathleff (2016) on the basis of international opinion from 21 international experts and subsequent review by 20 patients diagnosed with PFP to ensure clarity.
Duration: Within the time constraints of a Masters Degree, patients will be recruited over a four month period. There will be four months for follow up and a further four months for write up, total study duration 12 months.
Detailed description
Design: A feasibility study to assess if a physiotherapy education session in addition to standard care improves patients scores regarding catastrophizing and kinesiophobia when measured by KOOS-PF, Pain Catastrophizing Scale and Tampa Scale
Objectives:
- To assess if providing a specific education session which reviews patients beliefs about crepitus, causes of pain, joint mechanics and purpose of exercise has an effect on catastrophizing and kinesiophobia.
- To identify if the study is feasible on a larger scale, which would allow the intervention to be assessed for efficacy. If a future study was able to demonstrate that the intervention was effective this would provide an additional evidence based intervention for use in clinical practice.
Recruitment: NHS patients diagnosed in a Musculoskeletal Clinical Assessment Service [MCAS] with patellofemoral pain at the South Liverpool Treatment Centre.
Inclusion criteria:
- Adults aged 18-40
- Be able to understand and converse in English
- Clinical diagnosis of PFP
- Be able to attend for up-to 12 weeks of physiotherapy
Exclusion criteria:
- Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side.
- A diagnosis of patellofemoral joint (PFJ) OA as confirmed by X-Ray or Magnetic Resonance Imaging (MRI).
Sample size: There is limited published research regarding the use of the questionnaire KOOS-PF in research. As a result it is not possible to do a definitive study to test whether or not the education session effects patient outcome. Therefore it is necessary to do a feasibility study with a small sample size of 24 patients (control n=12, intervention n=12) which will allow any change in the questionnaire scores to be used to calculate how many patients would be needed for a definitive study which would allow researchers to assess whether or not the exercise intervention affected patient outcome, which could improve patient care. The research team are confident that the required number of patients could be recruited as audit data from the service identified that 104 patients in the MCAS service met the criteria for inclusion in this proposed study.
Baseline measures: Participants' characteristics including age, gender and duration of symptoms will be collected alongside baseline measures for the chosen questionnaires - the KOOS-PF, Tampa-scale for Kinesiophobia and Pain Catastrophizing. These questionnaires will be repeated at 12 weeks.
Intervention: Patients recruited into the study will be randomised to either the intervention (n=12) or the control group (n=12). Participants in the control group will undergo standard treatment.
The intervention: Participants in the intervention group will receive standard treatment plus the education session.
The education session will be based on a leaflet produced by other leading researchers in the field and will also explore the causes of pain, beliefs about pain, beliefs about noise that come from the joint, the impact of the pain on activity and the influence of other family members' experience and beliefs about knee pain. At 12 weeks, participants from both groups will be asked to repeat the questionnaires.
Statistical analysis: Descriptive statistical analysis will be performed on the data and the lead researcher will work with the statistics department at MMU to review the change in the chosen questionnaires to identify the sample size required for a definitive study which will assess how effective the education session is on patients' symptoms of PFP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Placebo comparator | Other: PhysiotherapyParticipants will receive standard physiotherapy care, which will involve strength exercises and taping. |
| Physiotherapy + education | Experimental | Other: Physiotherapy + education, Other: PhysiotherapyPhysiotherapy + education Standard physiotherapy care plus 30 minute education session addressing fear of movement and catastrophizing thoughts. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-40
- Be able to understand and converse in English
- Clinical diagnosis of PFPS
- Be able to attend for up-to 12 weeks of physiotherapy
Key exclusion criteria (2 listed)
- Patients who present with referred pain from the spine or hip, or have tibiofemoral pathology of any nature on the ipsilateral side.
- A diagnosis of PFJ osteoarthritis as confirmed by X-Ray or MRI.
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 |
|---|---|---|
| Physiotherapy + educationParticipants will take part in a 30 minute education session surrounding fear of movement and catastrophizing thoughts. They will then receive standard care, which will involve strength exercises and taping if needed. | Other | Physiotherapy + education |
| PhysiotherapyStandard physiotherapy care | Other | Physiotherapy, Physiotherapy + education |
Primary outcome
Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF)
Time frame: 12 weeks following baseline visit
The KOOS-PF is an 11 item, patient reported outcome measure of pain and function where a maximum score of 100 indicates no problems and a minimum score of 0 indicates extreme problems.
2 secondary outcomes
Tampa Scale for Kinesiophobia (TSK)
Time frame: 12 weeks following baseline visit
Pain Catastrophizing Scale (PCS)
Time frame: 12 weeks following baseline visit
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 26 Feb 2020.
- Individual participant dataSharing planned: No
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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.
James Selfe study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy + education and Physiotherapy in people with Knee Cap, run by Manchester Metropolitan University at 1 site in United Kingdom.
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 4 inclusion and 2 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 26 Feb 2020. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Knee Osteoarthritis Outcome Score - Patellofemoral (KOOS-PF) (time frame: 12 weeks following baseline visit). 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 26 Feb 2020.