effectiveness of flossing technique in addition to routine physical therapy on pain and range of motion in patients with patellofemoral pain syndrome: A randomized controlled trial
To determine the effectiveness of flossing techniques on pain and range of motion in patients with patellofemoral pain syndrome
Design
It will be a two arm parallel Randomized trial with outcome assessor being blinded
Settings and conduct
Data will be collected from outpatient department of REX clinic Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
(1)Patients with age 14-40 will be included
(2)Diagnosed patients with patellofemoral pain syndrome having three months history of pain
(3) patients with positive clinical patellar test
Exclusion Criteria:
Patients with history of knee Osteoarthritis, fracture of knee joint, malignancy will not be included in the trial
Intervention groups
Group A will receive Routine physical therapy which involves standing hamstring stretch, quadriceps stretch, side lying leg lift, Quads sets, straight leg raise, step up, wall squats and stabilization exercises
Group B will receive flossing exercises along with routine physical therapy. Floss band which is stretchable will be used for this purpose.
Main outcome variables
Pain, functional disability and range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220610055129N1
Registration date:2022-06-22, 1401/04/01
Registration timing:retrospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
saba saeed
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 335 6781981
Email address
sabasaeed2633@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-24, 1400/10/03
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectiveness of flossing technique in addition to routine physical therapy on pain and range of motion in patients with patellofemoral pain syndrome: A randomized controlled trial
Public title
Effects of flossing techniques along with routine exercises on pain and range of motion of knee in patients with patellofemoral pain syndrome:A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed patients with patellofemoral pain syndrome having three months history of pain
Patients having positive clinical patellar test will be included
Exclusion criteria:
Patients with Osteoarthritis of knee joint, patellar tendinopathy will not be included
Patients with Osgood Schlatter disease
Those with recent history if fracture of knee joint will not be included in the trial
Those who will have had history of malignancy will not be taken into account
Age
From 14 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Data will be taken at baseline, 2nd and 6th week post intervention
Randomization (investigator's opinion)
Randomized
Randomization description
Total 60 participants will be randomly allocated into two groups using computer generated randomization method in which computer software will be utilized to randomly allocate participants in either group A or Group B. Then it will be concealed in and envelope and participant will be given concealed envelopes. Convenient random sampling technique will be used
Blinding (investigator's opinion)
Double blinded
Blinding description
It will be Double blinded study as assessor and caregiver will be unaware of the treatment given to patient. Treatment will be carried out in the treatment room with only patient and physiotherapist present and assessor and caregivers will not be given any information on which technique they applied to the participant. In this way they will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee and Institutional review board of University of Lahore
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Approval date
2021-12-23, 1400/10/02
Ethics committee reference number
IRB-UOL-FAHS/1086/2021
Health conditions studied
1
Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2X9
ICD-10 code description
Patellofemoral disorders, unspecified knee
Primary outcomes
1
Description
Pain
Timepoint
Primary outcome will be measured at baseline, 3rd and 6th week post intervention
Method of measurement
Pain will be assessed using Visual Analog Scale
2
Description
Functional disability
Timepoint
It will be assessed at Baseline, 3rd and 6th week post intervention
Method of measurement
It will be measured using Lower Extremity Functional Index
3
Description
Range of motion
Timepoint
Range of motion will be assessed at Baseline, 3rd and 6th week post intervention
Method of measurement
Range of motion will be measured using Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: will receive Routine physical therapy. In routine physical therapy stabilization exercises of knee along with other exercises will be performed which includes quads sets exercises, side lying leg lift, straight leg raise, step up, wall squats.
Category
Treatment - Other
2
Description
Intervention group: will receive flossing exercises along with the routine physical therapy. Floss band will be used for this purpose.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
REX clinic Lahore
Full name of responsible person
Ashfaq Ahmad
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Phone
+92 51 3544112
Email
Ashfaq.ahmad@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Asadullah Arsalan
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Phone
+92 922 111 844 844
Email
asadshahgilani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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
Sialkot college of physical therapy Sialkot
Full name of responsible person
Nusrat Qamar
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Nawan pind aimnabad road, Sialkot
City
Sialkot
Province
Punjab
Postal code
51040
Phone
092513544112
Email
dr.nusratqamar55@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmad
Position
Associate Dean
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
1km.off defence road, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
09221111844844
Email
ashfaq.ahmad@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Sialkot college of physical therapy Sialkot
Full name of responsible person
Nusrat Qamar
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Nawan pind aimnabad road, Sialkot
City
Sialkot
Province
Punjab
Postal code
51040
Phone
092513544112
Email
dr.nusratqamar55@gmail.com
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
Effects of flossing techniques along with the routine physical therapy on pain and range of motion in patients with patellofemoral pain syndrome: A randomized controlled trial
All collected deidentified IPD will be shared
When the data will become available and for how long
Data will become available after 15 December 2022 for a period of 3 years
To whom data/document is available
People working in academics or who are involved in clinical trials or to students for research purposes
Under which criteria data/document could be used
Data can be used for research purpose only
From where data/document is obtainable
Data can be obtained by sending an email
What processes are involved for a request to access data/document
Data can be obtained by sending an email to dr.nusratqamar55@gmail.com