The survey the effect of foot orthoses on medial tibia stress syndrome in recreational runners
Design
The present research is a prospective, randomized, controlled, clinical trial with parallel groups.
Settings and conduct
Shahrood sports clubs
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 25 years; Taking running for at last 4 months; Running less than 45 min and/or less than 10 km per session and less than 3 times per week; having the ability to run at a self-selected speed for approximately 30 min and/or 5 km at a time.
Exclusion criteria: History of lower limb traumatic injury or surgery within the last 6 months; Hallux valgus; Obvious leg-length discrepancy
Intervention groups
Orthoses group will use arch-support full-length foot-orthoses that made from 4-mm thick polypropylene of medium density (Durometer Shore 50A) with an approximately 15-mm high heel cup and a 25-mm peak height arch support.
The control group will have their usual daily living conditions.
Main outcome variables
Pain severity; Functional impairment related to pain ; Physical activity level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031942N8
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2018-10-12, 1397/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of foot orthoses on pain and physical function of recreational runners with medial tibia stress syndrome
Public title
Foot orthoses and medial tibia stress syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 25 years
Taking up running in the last 4 months, running less than 3 times per week for <45 min and/or <10 km per session
Having the ability to run at a self-selected speed for approximately 30 min and/or 5 km at a time
Pain is induced by exercise
Pain is located in the distal half of the posteromedial side of tibia
Not being overweight (BMI > 30 kg•m-2)
Exclusion criteria:
History of paresthesia
Symptoms indicative of other causes of exercise-induced leg pain (such as tibial stress fracture and chronic compartment syndrome)
History of used arch-support orthoses
Receiving physiotherapy treatment in the previous 6 months
Current using anti-inflammatory medications
History of lower limb traumatic injury or surgery within the last 6 months
Hallux valgus
Obvious leg-length discrepancy
Age
From 18 years old to 25 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant's foot can be a sample.
Randomization (investigator's opinion)
Randomized
Randomization description
First, participants are enrolled by one of the research colleague. Then, a random allocation sequence using a computer Software is created. In this sequence, participants with 1:1 allocation ratio are randomly divided into control and orthoses groups. A block randomization design (block size of 2, 4, and 6) is applied in this study. Group allocation is concealed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened after completion of all baseline assessments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Hafte Tir Square, Shahroud
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.SHMU.REC.1396.194
Health conditions studied
1
Description of health condition studied
Medial tibial stress syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain severity
Timepoint
Before the intervention and 6, 12 and 18 weeks after the intervention
Method of measurement
Visual analog scale
2
Description
Activity limitations level
Timepoint
Before the intervention and 6, 12 and 18 weeks after the intervention
Method of measurement
Run distance
3
Description
Perceived Treatment Effect
Timepoint
Before the intervention and 6, 12 and 18 weeks after the intervention
Method of measurement
5-point Likert scale of perceived Treatment
4
Description
Dynamic Arch Index
Timepoint
Before the intervention and 6, 12 and 18 weeks after the intervention
Method of measurement
Footprint
5
Description
Lower extremity function
Timepoint
Before the intervention and 6, 12 and 18 weeks after the intervention
Method of measurement
Medial tibial stress syndrome score
Secondary outcomes
1
Description
Plantar pressure
Timepoint
Before the intervention and 6,12 and 18 weeks after the intervention
Method of measurement
Foot pressure plat
2
Description
Quality of life
Timepoint
Before the intervention and 6,12 and 18 weeks after the intervention
Method of measurement
Short Form (36) Health Survey
Intervention groups
1
Description
Intervention group: Arch-support full-length foot-orthoses were made from 4-mm thick polypropylene of medium density (Durometer Shore 50A) with an approximately 15-mm high heel cup and a 25-mm peak height arch support
Category
Prevention
2
Description
Control group: Routine daily activity
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrood city
Full name of responsible person
Aynollah Naderi
Street address
Shahrood University of Technology, Tehran Road
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Aynollah Naderi
Street address
Tehran avenue, Shahroud, Semnan province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ay.naderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Technology
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
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD