History
# Registration date Revision Id
2 2023-12-11, 1402/09/20 289446
1 2023-08-18, 1402/05/27 275725
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluate the effects of instrument assisted soft tissue mobilization and deep transverse friction massage on pain and gait parameter among patients with Iliotibial band syndrome.
Design
Randomized clinical trial, Non-probability purposive sampling technique (random allocation to groups by means of lottery method) was used in this study.
Settings and conduct
• Physio Fixx Physiotherapy & Pain Relief Center, Faisalabad • Physiotherapy & Pain Relief Center, Faisalabad • Physiotherapist Center, Faisalabad • Recovery Healthcare Clinic, Faisalabad • InMotion Physiotherapy and Rehabilitation Clinic, Faisalabad • Human Care Physiotherapy and Rehab Center, Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria • Male patients with IT band tightness • Sitting for minimum 6-7 hour • Positive Ober’s test • Age ranging between 25-45 years • Having pain (3-7 on numeric pain rating scale) • Willing to participate was included into study Exclusion Criteria • Participants with any diagnosed musculoskeletal or auto-immune disorder • Having co-morbidities such as neoplasm etc • Undergone lower limb surgery in past 6 months • Having any neurological or vascular disorders or infectious disease • Participants with physical impairment • Participants taking medication (NSAIDS and steroids)
Intervention groups
For group A Instrument assisted soft tissue mobilization (IASTM) was given for 10 mins of warm up session using ultrasound as baseline treatment. For group B transverse deep friction massage was given along with the baseline treatment.
Main outcome variables
Pain, Range of motion, Q angle

General information

Reason for update
Acronym
IASTM (INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION), DTFM (DEEP TRANSVERSE FRICTION MASSAGE), ITBS (ILIOTIBIAL BAND SYNDROME)
IRCT registration information
IRCT registration number: IRCT20230413057897N1
Registration date: 2023-08-18, 1402/05/27
Registration timing: retrospective

Last update: 2023-08-18, 1402/05/27
Update count: 1
Registration date
2023-08-18, 1402/05/27
Registrant information
Name
Muhammad Hanan Abdullah
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 310 7436476
Email address
abdullahhanan920@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-25, 1402/01/05
Expected recruitment end date
2023-04-25, 1402/02/05
Actual recruitment start date
2023-03-30, 1402/01/10
Actual recruitment end date
2023-04-30, 1402/02/10
Trial completion date
2023-05-05, 1402/02/15
Scientific title
COMPARATIVE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION AND DEEP TRANSVERSE FRICTION MASSAGE ON PAIN AND GAIT PARAMETERS OF ILIOTIBIAL BAND SYNDROME
Public title
COMPARATIVE EFFECTS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION AND DEEP TRANSVERSE FRICTION MASSAGE ON PAIN AND GAIT PARAMETERS OF ILIOTIBIAL BAND SYNDROME
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients with IT band tightness Sitting for minimum 6-7 hour Positive Ober’s test Age ranging between 25-45 years Having pain (3-7 on numeric pain rating scale) Willing to participate will be included into study
Exclusion criteria:
Participants with any diagnosed musculoskeletal or auto-immune disorder Having co-morbidities such as neoplasm etc Undergone lower limb surgery in past 6 months Having slump test negative Having any neurological or vascular disorders or infectious disease Participants with physical impairment Participants taking medication (NSAIDS and steroids)
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Study is randomized control trial and purposive sampling technique (random allocation to groups by means of lottery method) used in this study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
RESEARCH AND ETHICS / TECHNICAL COMMITTEE
Street address
Faisal Town, West Canal Road
City
Faisalabad
Postal code
38000
Approval date
2023-03-10, 1401/12/19
Ethics committee reference number
2021-MSPT-070

Health conditions studied

1

Description of health condition studied
ILIOTIBIAL BAND SYNDROME
ICD-10 code
M76.3
ICD-10 code description
Iliotibial band syndrome

2

Description of health condition studied
PAIN OF ILIOTIBIAL BAND SYNDROME
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain

3

Description of health condition studied
GAIT IN ILIOTIBIAL BAND SYNDROME
ICD-10 code
R26.89
ICD-10 code description
Other abnormalities of gait and mobility

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and 3 week after intervention
Method of measurement
Numerical Pain Raiting Scale

2

Description
Hip range of motion (abduction)
Timepoint
Before intervention and 3 week after intervention
Method of measurement
Goniometer

3

Description
Q angle
Timepoint
Before intervention and 3 week after intervention
Method of measurement
Goniometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: IASTM
Category
Treatment - Devices

2

Description
Intervention group: DTFM
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physio Fix Physiotherapy & Pain Relief Center
Full name of responsible person
Nabeel Zahid
Street address
Peoples Colony#1 Canal Road Fsd
City
Faisalabad
Postal code
38000
Phone
+92 310 7436476
Email
abdullahhanan920@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Street address
4-Km Sargodha road, University Town, Faisalabad. Pakistan
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
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
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
4-Km, Sargodha road, Faislabad. Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hanan Abdullah
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F-513 Gulistan colony no 1 Raja Road Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 310 7436476
Email
abdullahhanan920@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University f Faialabad
Full name of responsible person
Hanan Abdullah
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F-513 Gulistan colony no 1 Raja Road Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 310 7436476
Email
abdullahahan920@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all collected de identified participants data set for outcome measures.
When the data will become available and for how long
4 months
To whom data/document is available
people working in academic institutions.
Under which criteria data/document could be used
IPD and any other additional documents
From where data/document is obtainable
contact person: Hanan Abdullah Contact no. 92310-7436476
What processes are involved for a request to access data/document
Data will be provided by contacting the above mentioned person.
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