Protocol summary

Study aim
The aim of this study is to investigate the effects of exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum self-myofascial-release on pain , function and balance in patients with patellofemoral pain (PFP)through telerehabilitation
Design
A randomized clinical trial with controlled, paralleled groups, single blind with a sample size of 60 people
Settings and conduct
Patients with PFP who refer to clinics affiliated to Shiraz University of Medical science will be divided into 2 groups randomly. The assessor will unaware of grouping patients and their allocation.
Participants/Inclusion and exclusion criteria
Patients with PFP that the onset of pain is more than1 month and they report 30 from 100 on the pain Visual Analogue Scale(VAS) in the last week also they have at least one trigger point in ipsilateral Gluteus Medius, Contralateral Quadratus Lumborum and Quadriceps and they are able to use internet properly are included in this study. Exclusion criteria including history of lower extremity injury and surgery, infections, neurologic and systemic diseases
Intervention groups
Intervention group: Patients with PFP will receive videos including exercise program and self-myofascial release techniques weekly for 4 weeks .They perform exercise 3 times a week and self-myofascial release techniques twice a week. In order to ensure that participants do exercise and techniques correctly, video calls will make. Control group: They are the same as intervention group, but they do not perform self-myofascial release techniques. On assessment day, everyone receives pamphlet.
Main outcome variables
Pain, function and balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220628055300N1
Registration date: 2022-07-27, 1401/05/05
Registration timing: prospective

Last update: 2022-07-27, 1401/05/05
Update count: 0
Registration date
2022-07-27, 1401/05/05
Registrant information
Name
Safoora Akhavan Hariri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
safoora.physio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum self-myofascial-release on pain , function and balance in patients with patellofemoral pain through telerehabilitation
Public title
The effects of exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum self-myofascial-release in patellofemoral pain through telerehabilitation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between the ages of 18 and 45 (both sexes). The onset of pain is more than 1 month which is aggravated by at least two of these activities prolonged sitting, squatting , kneeling ,running ,upstairs and downstairs ,jumping and landing also pain is at least 30 from 100 on visual analogue scale during activities. Unilateral anterior knee pain, prepatellar or retro patellar pain that person reports at least 30 from 100 on pain visual analogue scale in the last week. If the pain is bilateral, the side with more pain is considered. Positive Clarke's sign KUJALA questionnaire score is less than 85 The presence of trigger points in Gluteus Medius muscle of the affected side, Quadratus Lumborum on the opposite side and at least one part of the Quadriceps muscle. People have ability to use the Internet and virtual communication.
Exclusion criteria:
History of back, hip, ankle or other anatomical knee structures injury in previous 6 months History of lower limb trauma in recent 6 months History of knee surgery History of lower limb surgery Meniscus or knee ligaments injury Patellar tendinopathy History of patellar dislocation History of knee intra-articular injection in last 3 months Systemic or local infections Referral pain from lumbar region Writing and speaking inability Systemic diseases such as Rheumatoid Arthritis and other inflammatory joint diseases Neurological disease such as Multiple Sclerosis, history of stroke and any other nervous system problem Person has received physiotherapy due to his problem since 6 months ago. Sever lower limb deformity People who are suffering from cancer or history of chemotherapy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Using of randomization software,60 numbers are dedicated to each case and the program defines 15 blocks of 4, 2 of which are allocated to exercise therapy plus Quadriceps , Gluteus Medius and Quadratus Lumborum self-myofascial-release through telerehabilitation group and the other 2 people are placed in exercise therapy through telerehabilitation group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who evaluates the patients is completely unaware of grouping patients and their allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in Research, Shiraz Faculty of Rehabilitation Sciences
Street address
Abiverdi1 Street, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
33669-71947
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.SUMS.REHAB.REC.1401.016

Health conditions studied

1

Description of health condition studied
Patellofemoral pain
ICD-10 code
M25.56
ICD-10 code description
Pain in knee

Primary outcomes

1

Description
Pain
Timepoint
Before treatment, immediately after the last treatment session and two weeks after the end of the treatment
Method of measurement
Visual Analogue Scale

2

Description
Pressure pain Threshold
Timepoint
Before treatment and immediately after the last treatment session
Method of measurement
Algometer

3

Description
Function
Timepoint
Before treatment, immediately after the last treatment session and two weeks after the end of the treatment
Method of measurement
KUJALA questionnaire

4

Description
Lower extremity function
Timepoint
Before treatment, immediately after the last treatment session and two weeks after the end of the treatment
Method of measurement
Lower Extremity Functional Scale

5

Description
Balance
Timepoint
Before treatment, immediately after the last treatment session and two weeks after the end of the treatment
Method of measurement
Modified Star Excursion Balance Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: exercise therapy with Quadriceps, Gluteus Medius, Quadratus Lumborum self-myofascial release through telerehabilitation in patients with patellofemoral pain. On assessment day, they are given pamphlet including exercises and pictures related to them and advice about changing their poor habits such as avoiding sitting for a long time and sitting on a short chair then they will be received videos including exercise program and self-myofascial release every week for four weeks also video calls are made to them every week to ensure the correct way of doing the exercises .These people are asked to do exercises 3 times a week and before starting, use a cold pack on their knees for 20 minutes. Also, these people do self-myofascial release techniques on 2 of the 3 days.
Category
Rehabilitation

2

Description
Control group: exercise therapy through telerehabilitation in patients with patellofemoral pain. Pamphlet, exercise therapy program, exercises frequency, exercises video and video call for this group is the same as intervention group. They just do not perform self-myofascial release techniques.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation
Full name of responsible person
Sara Abolahrari-Shirazi
Street address
Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
SAhrari@Sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Research vice-chancell, Central Building of Shiraz University of Medical Science, Opposite Palestine Street, Zand Street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
+98 71 3235 9317
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahrari-Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
۱۷۳۳-۷۱۳۴۵
Phone
+98 71 3627 1551
Email
SAhrari@Sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahrari-Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1552
Email
SAhrari@Sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Safoora Akhavan Hariri
Position
M.Sc. Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
safoora.physio@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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