Protocol summary

Study aim
Is to examine the efficacy of a modified active physical therapy (MAPT) program on pain, hip and trunk muscle strength, and function in young athletes with osteitis pubis .
Design
The study was designed as a randomized clinical trial, parallel-group design, of two interventions.
Settings and conduct
All assessments and interventions will be carried out at the outpatient clinic of Health and Rehabilitation Sciences Department, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj City, Saudi Arabia
Participants/Inclusion and exclusion criteria
The athletes will be included if they have 1) unilateral or bilateral groin pain that increases with movement as sprinting, cutting, and sit-ups and disappear by rest, 2) positive squeeze test, 3) positive symphysis pubis stress tests 4) pubic bone and pubic symphysis joint tenderness with palpation. Exclusion criteria will be; all other differential diagnosis leading to groin pain (e.g. inguinal or femoral hernia, prostatitis or urinary tract disorders), a history of lower limb surgery and/or trauma to the back or hip.
Intervention groups
- Two groups: MAPT group and traditional physical therapy (TPT) group. - The MAPT in this study consisted of four stages. Each stage lasted for three weeks. *1st stage: Pain control & lumbopelvic stability exercise *2nd stage: Strengthening and core stability exercises *3rd stage: Closed kinetic chain exercises and balance training *4th stage: Plyometrics and sport specific training - The TPT group used basic physiotherapy methods including hot packs, Transcutaneous electrical nerve, transverse friction massage, stretching exercise for hip flexors, hip adductors, and hamstring muscles, and Laser therapy.
Main outcome variables
- athletes pain, - hip and trunk muscle strengths - lower limb function,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210909052421N3
Registration date: 2023-04-09, 1402/01/20
Registration timing: retrospective

Last update: 2023-04-09, 1402/01/20
Update count: 0
Registration date
2023-04-09, 1402/01/20
Registrant information
Name
Nadia Radwan
Name of organization / entity
Prince Sattam Bin Abdulaziz University
Country
Saudi Arabia
Phone
+966 11 588 6500
Email address
n.radwan@psau.edu.sa
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-11, 1401/07/19
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a Modified Active Physical Therapy Program on Pain, Muscle Strength, and Function in Adolescent Football Players with Osteitis Pubis
Public title
Efficacy of a Modified Active Physical Therapy Program in athletes with Osteitis Pubis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male adolescent football players suffering from osteitis pubis (OP). The player’s age ranged from 12 to 18 years, with a history of OP pain extended more than 3 months. If they have unilateral or bilateral groin pain that increases with movement as sprinting, cutting, and sit-ups and disappear by rest. If they have positive squeeze test, positive symphysis pubis stress tests. if they have pubic bone and pubic symphysis joint tenderness with palpation.
Exclusion criteria:
All other differential diagnosis leading to groin pain (e.g. inguinal or femoral hernia, prostatitis or urinary tract disorders), A history of lower limb surgery and/or trauma to the back or hip.
Age
From 12 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
- A researcher who was not involved in the study performed the randomization using enclosed envelopes. - The researcher prepared the enclosed envelopes, each envelope with a labeled card as either a modified active physical therapy (MAPT) or traditional physical therapy (TPT) group. - Each patient was requested to choose an enclosed envelope, 1:1 simple randomization, that determined whether he was allocated randomly to the MAPT group or TPT group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The examining researcher was not included in the randomization process and still unaware of the group allocation. During their assessment, patients were asked not to report their treatment allocation to the examiner.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Standing Committee of Bioethics Research (SCBR) in the College of Applied Medical Sciences, Prince
Street address
ALmanifeia, Alraghi building
City
Alkharj
Postal code
00966
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
SCBR-072-2022

Health conditions studied

1

Description of health condition studied
osteitis pubis
ICD-10 code
M70.85
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure of thigh

Primary outcomes

1

Description
pain
Timepoint
pain will be measured at baseline and one week after the end of the treatment period for both groups.
Method of measurement
Visual analog scale (VAS)

2

Description
hip and trunk muscle strength
Timepoint
hip and trunk muscle strength will be measured at baseline and one week after the end of the treatment period for both groups.
Method of measurement
handheld dynamometer will be used to measure muscle strength

3

Description
lower extremity function
Timepoint
it will be measured at baseline and one week after the end of the treatment period for both groups.
Method of measurement
lower extremity functional scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group. The modified active physical therapy (MAPT) group consisted of four stages. Each stage lasted for three weeks. Stage 1: Pain control & lumbopelvic stability - Stage 2: Strengthening and core stability exercises., Stage 3;Closed kinetic chain exercises and balance training, Stage 4:Plyometrics and sports specific training
Category
Rehabilitation

2

Description
Control group: The traditional physical therapy (TPT) group used basic physiotherapy methods.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Alshulla club
Full name of responsible person
Khalefah Abdullah Altofel
Street address
Mesherif 15- 45
City
Alkharj
Postal code
00966
Phone
+966 50 510 4187
Email
alshullaclub@ alshullaclub.net
Web page address
http://alshullahclub.com/About

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Prince Sattam bin Abdul-Aziz university
Full name of responsible person
Mohammed Alshehri
Street address
ALmanifeia
City
Alkharj
Postal code
00966
Phone
+966 11 588 6556
Email
ah.alshehri@psau.edu.sa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self funding
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Prince Sattam bin Abdulaziz University
Full name of responsible person
Nadia Lotfy Radwan
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
ALmanifeia, Alraghi building
City
Alkharj
Province
Riyadh
Postal code
00966
Phone
+966 56 172 8094
Email
n.radwan@psau.edu.sa

Person responsible for scientific inquiries

Contact
Name of organization / entity
prince sattam bin Abdul-Aziz university
Full name of responsible person
Marwa Mohamed Ibrahim
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Albatha
City
Alkharj
Province
Riyadh
Postal code
00966
Phone
+966 11 588 6553
Email
assprofpnu@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
prince sattam bin Abdul-Aziz university
Full name of responsible person
Waleed Salah Eldin Mahmoud
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Algamiaa
City
Alkharj
Province
Riyadh
Postal code
00966
Phone
01158552346
Email
waleeds306@yahoo.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
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
Patient information sheet , raw data , results
When the data will become available and for how long
After publication
To whom data/document is available
public
Under which criteria data/document could be used
statistical analysis
From where data/document is obtainable
Research gate
What processes are involved for a request to access data/document
via email. research gate
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