Effect of Designated Education Session on Patellofemoral Pain

NCT03784339 | Completed

• 1 other identifier: PatellofemoralPain_DEC2018
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Knee Cap

Keywords

Patellofemoral; Knee

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks following baseline visit

Secondary Outcomes (2)

• Tampa Scale for Kinesiophobia (TSK)

  12 weeks following baseline visit

• Pain Catastrophizing Scale (PCS)

  12 weeks following baseline visit

Study Arms (2)

Physiotherapy

PLACEBO COMPARATOR

Participants will receive standard physiotherapy care, which will involve strength exercises and taping.

Other: Physiotherapy

Physiotherapy + education

EXPERIMENTAL

Physiotherapy + education Standard physiotherapy care plus 30 minute education session addressing fear of movement and catastrophizing thoughts.

Other: Physiotherapy + education; Other: Physiotherapy

Interventions

Physiotherapy + education OTHER

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.

Physiotherapy + education

Physiotherapy OTHER

Standard physiotherapy care

Physiotherapy; Physiotherapy + education

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester Metropolitan University: lead

Study Sites (1)

Royal Liverpool & Broadgreen University Hospitals Trust

Liverpool, Merseyside, United Kingdom

Location

MeSH Terms

Conditions

Patella Fracture

Interventions

Physical Therapy Modalities; Educational Status

Condition Hierarchy (Ancestors)

Knee Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Socioeconomic Factors; Population Characteristics

Study Officials

• James Selfe

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Professions

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: March 2, 2019
• Primary Completion: August 13, 2019
• Study Completion: November 29, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)