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Trial registered on ANZCTR

Registration number

ACTRN12618000224224

Ethics application status

Approved

Date submitted

1/02/2018

Date registered

12/02/2018

Date last updated

21/02/2020

Date data sharing statement initially provided

21/02/2020

Type of registration

Retrospectively registered

Titles & IDs

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1202-2101

Trial acronym

BEEP Trial

Linked study record

Nil known

Health condition

Health condition(s) or problem(s) studied:

Patellofemoral Pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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: 10.1136/bmjsem-2015-000086"

Following this 6 week period, participants who do not consider themselves completely recovered will enter into phase 2: a double blind two arm pilot randomised trial conforming to CONSORT guidelines involving different physiotherapist led exercise and education interventions, provided over 12 weeks. The mode of administration of both interventions will be one-on-one (participant and physiotherapist).

The tested intervention will be a Physiotherapist-delivered exercise program.
- Physiotherapist-delivered exercise group
One physiotherapist (5 years' experience) will deliver a 12-weeks exercise program to the participants of this randomised controlled trial.
Participants will attend to 8 sessions in a Physiotherapy Clinic which will be distributed according to the topics below:
- Week 1: 1-hour session
- Week 2: 1-hour session
- Week 3: 1-hour session
- Week 4: 1-hour session
- Week 6: 1-hour session
- Week 8: 1-hour session
- Week 10: 1-hour session
- Week 12: 1-hour session

Besides the sessions with the physiotherapist, participants will be instructed to perform the exercises 2 times a week at home.

The adherence to the recommended home-based exercises and physiotherapy sessions will be assessed through the app "Physio Track", available at: http://www.physiotrack.co.uk/our-app/ or paper diary depending on preference

The intervention and recommendations will consist in progressive core, hip and knee strengthening exercises, gait retraining in gestures participants report knee pain and gradual exposure to pain exacerbating activities.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The comparator group will be a Physiotherapist-delivered Education.
- Physiotherapist-delivered Education group
One physiotherapist (5 years' experience) will deliver 12-weeks education program to the participants of this randomised controlled trial.

Participants will attend to 8 sessions via Skype to receive education about how to perform exercise and manage loads based on the material freely available on the website

Sessions will be distributed according to the topics below:
- Week 1: 1-hour session
- Week 2: 1-hour session
- Week 3: 1-hour session
- Week 4: 1-hour session
- Week 6: 1-hour session
- Week 8: 1-hour session
- Week 10: 1-hour session
- Week 12: 1-hour session

Besides the Skype sessions with the physiotherapist, participants will be instructed to perform the exercises 2 times a week at home.

The exercises instructions which will be given via Skype will be the same as those received by the Physiotherapist-delivered exercise group. The physiotherapist will advise participants via Skype to perform progressive core, hip and knee strengthening exercises, instructions about gait retraining in gestures participants report knee pain and gradual exposure to pain exacerbating activities.

The adherence to the recommended home-based exercises and Skype sessions will be assessed through the app "Physio Track", available at: http://www.physiotrack.co.uk/our-app/ or paper diary depending on preference.

Control group

Active

Outcomes

Primary outcome [1]

Worst knee pain in the previous week (Visual Analogue Scale 0 - 100mm)

Timepoint [1]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Primary outcome [2]

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.

Timepoint [2]

- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [1]

Kinesiophobia (TAMPA scale)

Timepoint [1]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [2]

Quality of Life (KOOS quality of life subscale)

Timepoint [2]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [3]

Catastrophism (Pain Catastrophism Scale)

Timepoint [3]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [4]

Self-efficacy (Knee self-efficacy scale)

Timepoint [4]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [5]

Digital literacy (Internet-literate tool). This tool was designed specifically for this study.

Timepoint [5]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [6]

Knee-related self-confidence (Question 3 of the KOOS - subscale quality of life)

Timepoint [6]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [7]

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.

Timepoint [7]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [8]

Pressure pain threshold (Center of patella)

Timepoint [8]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [9]

Pressure pain threshold (tibialis anterior)

Timepoint [9]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [10]

Pressure pain threshold (elbow)

Timepoint [10]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [11]

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.

Timepoint [11]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [12]

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.

Timepoint [12]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [13]

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.

Timepoint [13]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [14]

Knee extensors strength (Handheld dynamometer)

Timepoint [14]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [15]

Hip abductors strength (Handheld dynamometer)

Timepoint [15]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Secondary outcome [16]

Hip extensors strength (Handheld dynamometer)

Timepoint [16]

- Baseline
- 6 weeks after intervention commencement
- 18 weeks after intervention commencement

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using the RANDOM function of the software Microsoft Excel.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The sample size calculation for the RCT was made based on the findings of Esculier et al. (1) who provided an education program to participants with patellofemoral pain. To detect a mean difference of 34 cm in a pain visual analogue scale (0 to 100 mm) after 8 weeks of education program, with a standard deviation of 3.55, a=0.05, power=80%, 13 participants are needed in each group. Expecting a withdrawal rate of 15%, we will recruit 30 participants, 15 for each group.
We will consider as a minimally clinical important difference 20 mm in a pain visual analogue scale (0 to 100 mm) according to Crossley et al (2).

For the phase 1 of this study a dependent t test will be performed to compare the baseline outcomes and the outcomes after a 6-weeks self-direct education program.

For the phase 2 the outcomes will be analyzed using a separate 2-by-3 (group-by-time) mixed model analyses of variance. The factor of group will have 2 levels (Physiotherapist-delivered Exercise group and Physiotherapist-delivered Education group) and the repeated factor of time will have 3 levels (baseline, 6 weeks and 18 weeks after intervention). An intention-to-treat analysis will be performed using the last value-carried-forward method to impute values for all missing data.

(1) Esculier J-F, Bouyer LJ, Dubois B, et al. Is combining gait retraining or an exercise programme with education better than education alone in treating runners with patellofemoral pain?A randomised clinical trial. Br J Sport Med. 2017:In Press. doi:10.1136/bjsports-2016-096988.

(2) K.M. Crossley, K.L. Bennell, S.M. Cowan, S. Green, Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch. Phys. Med. Rehabil. 85 (2004) 815–822.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/02/2018

Actual

1/02/2018

Date of last participant enrolment

Anticipated

19/04/2018

Actual

15/05/2018

Date of last data collection

Anticipated

14/12/2018

Actual

10/12/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3000 - Melbourne

Recruitment postcode(s) [2]

3072 - Preston

Recruitment postcode(s) [3]

3083 - Bundoora

Recruitment postcode(s) [4]

3083 - La Trobe University

Recruitment postcode(s) [5]

3083 - Kingsbury

Recruitment postcode(s) [6]

3053 - Carlton

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country [1]

Australia

Primary sponsor type

Individual

Name

Christian John Barton

Address

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Danilo de Oliveira Silva

Address [1]

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country [1]

Brazil

Other collaborator category [1]

Individual

Name [1]

Kay Crossley

Address [1]

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Fábio Mícolis de Azevedo

Address [2]

University of Sao Paulo State. Roberto Simonsen Street, 305, 19060-900, Presidente Prudente-SP

Country [2]

Brazil

Other collaborator category [3]

Individual

Name [3]

Marcella Ferraz Pazzinatto

Address [3]

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Ebonie Rio

Address [4]

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Ethics Committee

Ethics committee address [1]

Plenty Road & Kingsbury Drive, Bundoora 3086 Melbourne VIC.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/09/2017

Approval date [1]

22/01/2018

Ethics approval number [1]

HEC17-102

Summary

Brief summary

Background: Knee pain is the second most common musculoskeletal complaint, second only to back pain. Both education and physiotherapist led exercise have been reported to be effective. However, to date, there is little research evaluating the effectiveness of education alone, and how many people still need physiotherapy following receiving appropriate education.
Population: 30 young people (18 - 40y/o) with knee pain.
Outcome measures: Pain, function, muscle strength, movement pattern, psychosocial factors, knowledge and quality of life.
Phase 1 intervention: 6 weeks of online and leaflet based self-directed education to teach how to manage pain including strategies and importance of exercises to improve pain. All outcome measures will be reassessed following the 6 week period.
Phase 2: Those who do not rate themselves as completely recovered following phase 1 will receive further 12 weeks tailored education and exercise guidance from a physiotherapist. This treatment will be randomly provided via 1 of 2 protocols: (i) 8 sessions of one on one physiotherapy to allow progression of exercise into a gym program; or (ii) 8 sessions of physiotherapy delivered via Skype to guide home exercises and educate them about their condition. Both groups will be reassessed for all outcome measures at the completion of this 12 week period.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Christian John Barton

Address

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country

Australia

Phone

+61403012914

Fax

[email protected]

Contact person for public queries

Name

Christian John Barton

Address

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country

Australia

Phone

+61403012914

Fax

[email protected]

Contact person for scientific queries

Name

Danilo de Oliveira Silva

Address

La Trobe University. Plenty Road & Kingsbury Drive, Bundoora 3086, Melbourne VIC

Country

Australia

Phone

+61420629982

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Any data collected by this study.

When will data be available (start and end dates)?

The data will be available from January 2019 up to January 2034.

Available to whom?

Researchers who provide a methodologically sound proposal.

Available for what types of analyses?

For IPD meta-analyses and other research purposes.

How or where can data be obtained?

The lead investigator Dr Christian Barton should be contacted.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7010	Ethical approval					373655-(Uploaded-14-01-2020-13-29-39)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Novel stepped care approach to provide education and exercise therapy for patellofemoral pain: Feasibility study.	2020	https://dx.doi.org/10.2196/18584

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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