Comparison of neuromuscular training by biofeedback method and conventional exercise therapy of hip abductor muscles on pain, function and electrical activity of the muscle in patients with patellofemoral pain syndrome
Determining the effect of gluteus medius muscle training with electromyography biofeedback during Functional activities and comparing it with routine therapeutic exercise of this muscle in patients with patellofemoral pain syndrome
Design
Clinical trial with control group, with parallel groups, single-blind, randomized on 30 patients. Coin flipping is used for randomization.
Settings and conduct
The study is conducted at Shahid Beheshti University of Medical Sciences. Both groups receive the usual physiotherapy. In addition, group A receives the common exercises of the gluteus medius muscle and group B receives functional exercises along with biofeedback. The evaluator does not know the group of patients and the study is single blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-40 years old; Anterior knee pain during at least 3 of following: stair ascent or descent, squatting, kneeling, jumping, running; Visual analog score ranging from 3 to 10; Positive patellar grind test; A history of at least 3 days of continuous pain in front of the knee (not caused by trauma) in the last 3 months, which is gradual; BMI 20-30
Exclusion criteria: Patella tendon pathology; Chondral damage of the knee joint; Osteoarthritis of the knee joint; Pain referred from the spine to the lower limbs; Neuromuscular, Rheumatology or Metabolic Diseases such as Diabetes and Neuropathy; Dislocation or subluxation of the patella and signs of meniscus or ligament damage; Trauma caused by injury or surgery in the lower limb in the last 12 months
Intervention groups
Group A receives the common strengthening exercises of the gluteus medius muscle.
Group B receives functional exercises of accent and decent stairs, walking and accent and decent stairs to the side along with biofeedback
Main outcome variables
Pain intensity; Function; Onset, offset and intensity of electrical muscle activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230725058919N1
Registration date:2023-08-16, 1402/05/25
Registration timing:prospective
Last update:2023-08-16, 1402/05/25
Update count:0
Registration date
2023-08-16, 1402/05/25
Registrant information
Name
Hossein Rabieifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1723
Email address
pt.rabieifar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neuromuscular training by biofeedback method and conventional exercise therapy of hip abductor muscles on pain, function and electrical activity of the muscle in patients with patellofemoral pain syndrome
Public title
Comparison of neuromuscular training and conventional exercise therapy of hip abductor muscles in patients with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 years old
Anterior knee pain during at least 3 of the following: stair ascent or descent; squatting; kneeling; jumping; running
Visual analog score ranging from 3 to 10
A history of at least 3 days of continuous pain in front of the knee (not caused by trauma) in the last 3 months, which is gradual.
Not receiving medical and physical treatment in the last three months
BMI 20-30
Positive patellar Grind test
Exclusion criteria:
Patella tendon pathology
Chondral damage of the knee joint
Osteoarthritis of the knee joint
Pain referred from the spine to the lower limbs
Neuromuscular, rheumatology or metabolic diseases such as diabetes and neuropathy
Dislocation or subluxation of the patella and signs of meniscus or ligament damage
Trauma caused by injury or surgery in the lower limb in the last 12 months
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with Non-transparent and sealed envelope tools in such a way that the letters A and B are inserted in the envelopes and patients are asked to select an envelope that the intervention group A and the group B they will be tested.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the patient knows which group he is in but the evaluator dose not know so this study is one-way blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak
Before the start of the intervention and after the end of the 10 intervention sessions (23 days after the start of the sessions)
Method of measurement
Visual Analogue Scale
2
Description
Knee function
Timepoint
Before the start of the intervention and after the end of the 10 intervention sessions (23 days after the start of the sessions)
Method of measurement
KOOS questionnaire
3
Description
Electromyographic activity of muscles
Timepoint
Before the start of the intervention and after the end of the 10 intervention sessions (23 days after the start of the sessions)
Method of measurement
Electromyography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Functional exercise therapy group with biofeedback: participants in 10 sessions and 3 sessions per week, in addition to regular physical therapy (the same in both groups), receive functional exercises of going up and down the stairs, walking and going up and down the stairs to the side along with biofeedback. In each of the activities, the patient is asked to increase the activity of the gluteus medius muscle, to activate the muscle early and even if possible to maintain the activity of the muscle until the end of the respective activity. The activities of going up and down the stairs and going up and down the stairs to the side are done as 4 sets with 5 repetitions and a 30-second rest between sets, and the walking activity as 4 repetitions of 90 seconds and a 30-second rest between repetitions. Each session lasts approximately 180 minutes.
Category
Rehabilitation
2
Description
Control group: Gluteus medius muscle strengthening exercise group: participants in 10 sessions and 3 sessions per week, in addition to regular physical therapy (the same in both groups), receive Gluteus medius muscle strengthening exercise group. The exercises become progressively more difficult, and when the patient can repeat the desired exercise 15 times without problems, the exercises will become more difficult and the external force will be gradually added (if 15 repetitions are done without problems, 1 pound of external resistance will be added). The exercises in order of difficulty are: abduction and external rotation in side lying position (clamshell), full thigh abduction with straight knee, thigh abduction in quadruped position. Each session lasts approximately 180 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Seyyed Morteza Kazemi
Street address
Akhtar Hospital., Azar Dead End., Sharifi Menesh St., in front of Qitarieh Metro., Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Email
akhtarhospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak.
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Rabeie Far
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
pt.rabieifar@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hoda Niknam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
009877561723
Email
hodaniknam@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Rabeie Far
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 8863 1084
Email
pt.rabieifar@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All above will be published in the article.
When the data will become available and for how long
After the article publication
To whom data/document is available
Researchers and students in academic centers
Under which criteria data/document could be used
Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication.
From where data/document is obtainable
After the article publication, people can find the article by searching in internet and access the data.
What processes are involved for a request to access data/document
After the article publication, people can find the article by searching in internet and access the data.