Protocol summary

Study aim
To determine the effect of periosteal pecking and shock absorbing insoles to improve pain and functional mobility in athletes with Medial Tibial Stress Syndrome.
Design
This study will be a Randomized Controlled Trial
Settings and conduct
Pakistan Sports Board
Participants/Inclusion and exclusion criteria
Inclusion Criteria • Pain along the posteromedial border of tibia that triggers with activity and relieves with rest • Positive single leg Hop test • Pain on resisted plantar flexion • local Tenderness < 5cm at distal postero medial border of tibia Exclusion Criteria • Athletes with Tibial stress fracture • Compartment syndrome • Popliteal artery entrapment
Intervention groups
Group A: 18 participants Participants will be given shock absorbing insoles and Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation. In addition Group A participants will receive periosteal pecking i.e. using dry needling technique, Pre, intermediate and post measures for NPRS, HOP Test and FMS will be taken. 3 follow ups for this session will be done on 0, 3rd and 6th week respectively. Group B: 18 Participants after allocation to Group B will be given shock absorbing insoles of a standard height of 1.5 cm for a period of 6 weeks and pre , intermediate and post reading of measuring tools NPRS, HOP Test and FMS will be taken on 0, 3rd and 6th week respectively.
Main outcome variables
Functional movement screening scale NPRS Hop test (single Hop, Triple Hop, Cross over Hop, 6 meter timed Hop

General information

Reason for update
Acronym
MTSS
IRCT registration information
IRCT registration number: IRCT20231103059934N1
Registration date: 2023-11-12, 1402/08/21
Registration timing: prospective

Last update: 2023-11-12, 1402/08/21
Update count: 0
Registration date
2023-11-12, 1402/08/21
Registrant information
Name
Laila Niaz khan
Name of organization / entity
Riphah International University, Lahore, Pakistan
Country
Pakistan
Phone
+92 345 1055934
Email address
lailaniaz321@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-04, 1402/09/13
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Shock Absorbing Insoles with and without Periosteal Pecking on Pain and Functional Mobility in Athletes with Medial Tibial Stress Syndrome
Public title
Effects of Periosteal pecking and shock absorbing insoles in Medial Tibial Stress syndrome in Atletes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain along the posteromedial border of tibia that triggers with activity and relieves with rest Tenderness at Tendo Achilles Positive single leg Hop test Positive 6 meters timed run Test local Tenderness < 5cm at distal postero medial border of tibia Pain on resisted plantar flexion
Exclusion criteria:
Compartment syndrome Popliteal artery entrapment Bilateral lower limb injuries Lumbar radiculopathy Athletes with Tibial stress fracture
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed Envelop
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study will be a Randomized Controlled Trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research & Ethics Committee
Street address
Riphah International University, Gullberg Campus, Lahore, Pakistan
City
Lahore
Postal code
54810
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
REC/RCR&AHS/23/04/0450

Health conditions studied

1

Description of health condition studied
Medial Tibial Stress syndrome
ICD-10 code
M70.8
ICD-10 code description
Tibialis Posterior tendon overuse injury

Primary outcomes

1

Description
Functional movement screening scale
Timepoint
Before intervention and 6th week after intervention
Method of measurement
Functional Movement Screening Scale

Secondary outcomes

1

Description
pain Reduction
Timepoint
Before intervention and 6th week after intervention
Method of measurement
Numerical Pain Rating Scale

Intervention groups

1

Description
Intervention Group 1 : 18 participants will be randomly allocated to Group A. Participants will be given shock absorbing insoles and Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation. In addition Group A participants will receive periosteal pecking i.e. using dry needling technique, in which dry needle of 30mm will be inserted at tendon osseous (T-O) junction and when it comes into contact with periosteum of tibia at distal posteromedial border, needle will be removed after 20 taps , it will promote growth and repair by stimulating inflammatory activity. Pre and post measures for NPRS, HOP Test and FMS will be taken. 3 follow ups for this session will be done on 0, and 6th week respectively.
Category
Treatment - Other

2

Description
Control Group: 18 Participants after allocation to Group B will be given shock absorbing insoles of a standard height of 1.5 cm for a period of 6 weeks and pre and post reading of measuring tools NPRS, HOP Test and FMS will be taken on 0, and 6th week respectively. Kinesthetic awareness exercises will be used as baseline treatment and will be given to all participants irrespective of their group allocation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Pakistan Sports Board Lahore
Full name of responsible person
Laila Niaz Khan
Street address
Pakistan Sports Board, Qazafi Stadium, Lahore
City
Lahore
Postal code
54810
Phone
+92 42 99232074
Fax
Email
infopsb@sports.gov.pk
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Dr. Muhammad Hashim
Street address
Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,
City
Lahore
Postal code
54660
Phone
+92 323 4071564
Email
Muhammad.hashim@riphah.edu.pk
Web page address
https://www.riphah.edu.pk/lahore/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University, 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
Riphah International University, Lahore
Full name of responsible person
Laila Niaz Khan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,
City
Lahore
Province
Punjab
Postal code
54660
Phone
+9234510055934
Email
lailaniaz321@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Laila Niaz Khan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 345 1055934
Email
lailaniaz321@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University, Lahore
Full name of responsible person
Laila Niaz Khan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University, Gulberg III Campus, Lahore 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore,
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 345 1055934
Email
lailaniaz321@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Loading...