Benefits of Education and Exercise Therapy for people with knee cap pain: BEEP Trial.

• Register: ANZCTR
• Last refreshed on: 3 March 2020
• Main ID: ACTRN12618000224224
• Date of registration: 12/02/2018
• Prospective Registration: No
• Primary sponsor: Christian John Barton
• Public title: Benefits of Education and Exercise Therapy for people with knee cap pain: BEEP Trial.
• Scientific title: Benefits of Education and Exercise Therapy delivered by Physiotherapists for people with patellofemoral pain (BEEP): Pilot Randomised Controlled Trial.
• Date of first enrolment: 01/02/2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000224224.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Christian John Barton

• Name: Mr Danilo de Oliveira Silva

Key inclusion & exclusion criteria

Inclusion criteria: The following inclusion criteria will be applied by a licensed physical therapist (> 5 years of clinical experience): i) anterior knee pain during at least two of the following activities: stair ascent or descent, squatting, prolonged sitting, kneeling, running, and jumping; ii) symptoms for at least one month with an insidious onset; and iv) pain level of at least 20 mm on a 100 mm visual analogue scale in the previous week.
Exclusion criteria: Exclusion criteria will be events of patellar subluxation or dislocation, lower limb inflammatory process, lower limb surgery, patellar tendon or meniscus tears, bursitis, ligament tears, or the presence of neurological diseases. Individuals who had received oral steroids and opiate treatment.

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Patellofemoral Pain;
Patellofemoral Pain

Physical Medicine / Rehabilitation - Physiotherapy

Intervention(s)

This trial will be divided in 2 phases:

For phase 1 and 2 participants will be asked to: avoid taking antiinflamatory or analgesic medications; avoid participating in any additional physiotherapy program; avoid making any drastically changes in their diet. Participants will be asked to report any of these events in their paper diary.

Phase 1 will involve a 6 week period of self-directed education using a purposely created online platform and printed leaflets.

- Self-directed education:
A physiotherapist (> 5 years' experience) will introduce the content of the website and leaflet for each participant in a 30-minutes session. The website was designed to educate patients with patellofemoral pain how to manage their knee pain by themselves based on the best evidence available. It will consist in 3 main topics:
1 - Understanding patellofemoral pain
- Why does it hurt?
- Diagnosis
- How common is patellofemoral pain?
- What pain is ok?
- When will my pain stop?
- Fear of movement
- Manage your load to manage your pain.

2 - Treatment options
- What works?
- Exercise
- Taping/Bracing
- Orthotics
- Other options?
- Surgery
- PRP
- Ultrasound

3 - Exercise program
- Exercise 1 - Bridges
- Exercise 2 - Core
- Exercise 3 - Hip
- Exercise 4 - Squats


In addition to the website, we will deliver an education leaflet titled "Managing my patellofemoral pain", which was previous published, also freely available for general public "Barton CJ, Rathleff MS ‘Managing My Patellofemoral Pain’: the creation of an education leaflet for patients BMJ Open Sport & Exercise Medicine 2016;2:e000086. doi: 10

Primary Outcome(s)

Global rating scale of recovery (6-itens Likert scale)
1 – Marked worsening.
2 – Moderate worsening.
3 – Same.
4 – Moderate improvement.
5 – Marked improvement.
6 – Completely recovered.[- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Worst knee pain in the previous week (Visual Analogue Scale 0 - 100mm)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Secondary Outcome(s)

Digital literacy (Internet-literate tool). This tool was designed specifically for this study.[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Kinesiophobia (TAMPA scale)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Pressure pain threshold (elbow)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Hip extensors strength (Handheld dynamometer)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Knee extensors strength (Handheld dynamometer)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Pressure pain threshold (Center of patella)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Quality of Life (KOOS quality of life subscale)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Single leg hop test (cm)

Description: The participants will be positioned with the heel in a marking on the floor and will be instructed to stand in unipodal support. Then, the participants will hop forward with their test leg as far as possible landing on the same foot. During this movement, the arms will not be allowed to swing. The distance of the jump will be measured in centimeters at the heel position from which the participant landed. In addition, the hop will be validated only if the participant is be able to maintain their balance upon landing, keeping their landing foot on the ground, without performing extra leaps, until the examiner marking where the participant landed. The test will be performed three times and we will consider the average of these 3 times. If the hop is not validated, the participants will be asked to repeat the task. [- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Hip abductors strength (Handheld dynamometer)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Knee-related self-confidence (Question 3 of the KOOS - subscale quality of life)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Catastrophism (Pain Catastrophism Scale)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Forward step-down test (quality of movement)

Description: Participants will be asked to stand on a 20.32cm high platform in a bipodal stance and step forward to tap with their non-test leg on the ground in front of the step, while keeping the tested leg on the step, before returning to starting position. After 5 consecutive trials is completed, an examiner will rate the performance of the participants across all 5 repetitions of the forward step=down. Standing 3 m directly in front of and facing the participant, the examiner will score the test, based on the following 5 criteria:
1. Arm strategy: if the participant uses an arm strategy to recover balance, 1 point will be given. Because participants will be instructed to keep their hands on their waist, removing their hands from their waist will be interpreted as a strategy to
recover balance.
2. Trunk movement: if the participant leans the trunk to either side, interpreted as recovering balance, 1 point will be given.
3. Pelvic plane: if 1 side of the pelvis rotates in the transverse plane or elevated in the frontal plane compared with the other side, 1 point will be given.
4. Knee position: if the knee of the tested limb moves medially in the frontal plane and the tibial tuberosity crosses an imaginary vertical line positioned directly over the second toe of the tested foot, 1 point will be given. If the knee moves medially and the tibial tuberosity crosses an imaginary vertical line positioned directly over the medial border of the tested foot, 2 points will be given.
5. Maintenance of a steady unilateral stance: if the participants has to support body weight on the nontested limb, or the foot of the tested limb moves during testing, 1 point will be given.[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Forward step-down test (repetitions)

Description: Participants will be asked to stand on a 20.32cm high platform in a bipodal stance and step forward to tap with their non-test leg on the ground in front of the step, while keeping the tested leg on the step, before returning to starting position. The number of repetitions that the participant perform in 30 seconds will be recorded, and for the repetition to be validated, the participant should touch the floor with only the heel, returning the position of complete extension of the knee without impelling. [- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Knowledge about patellofemoral pain (Pain CAT Knowledge Questionnaire. A questionnaire developed to assess participant’s knowledge about what Cause And possible Treatments for their knee pain). This tool was designed specifically for this study.[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Pressure pain threshold (tibialis anterior)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Self-efficacy (Knee self-efficacy scale)[- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

La Trobe University

Secondary Sponsor(s)

Danilo de Oliveira Silva

Ethics review

Status: Approved
Approval date: 22/01/2018
Contact:

La Trobe University Human Ethics Committee

Results

• Results available: Yes
• Date Posted: 21/02/2020
• Date Completed: 10/12/2018