1) Objectives:
Evaluation of effectiveness of custom-made foot orthoses for reducing pain and improving function in subjects with lower back pain and flatfoot
2) Study design:
A randomized, single-blinded, control group with a placebo
3) Setting and conduct:
Participants with flatfoot and chronic or recurrent low back pain will randomly allocate to two groups: treatment and control. Treatment group will treat with the custom-made foot orthoses, and control will treat with prefabricated orthoses. Low back pain was evaluated by a visual analog scale for pain and Oswestry’s Disability Index Questionnaire for lower back pain at four moments—on the day of inclusion in the study and after 6,12 and 24 weeks of using the orthoses.
4) Participants:
Subjects between 18-35 years old with chronic non-specific low back pain who have flatfoot will included and any pathologic or non-mechanical low back pain and previous use of foot orthoses will excluded.
5) Intervention:
One pair custom-made foot orthoses for treatment group that after the foot scan, foot orthoses was made based of each subject’s foot and was administered immediately after preparation. In control group one pair prefabricated orthoses was administered.
6) Main outcome: Low back pain which is evaluated by a visual analog scale(VAS) and function which is evaluated by Oswestry’s Disability Index Questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025308N1
Registration date:2016-01-05, 1394/10/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-05, 1394/10/15
Registrant information
Name
Maryam Mirshahi
Name of organization / entity
Sina Specialized & Subspecialty Hospital, Teharn University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8569
Email address
m-mirshahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of custom-made foot orthoses on pain and function in subjects with lower back pain and flatfoot
Public title
The effect of custom-made foot orthoses on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: subjects between 18-45 years old with pain between T12 and the S1 joints؛ presence of chronic non-specific low back pain for at least 6 weeks or recurrent low back pain for 3 month؛ Foot Posture Index (FPI-6) indicating at least +6
Exclusion criteria: any pathologic or non-mechanical low back pain؛ history of foot surgery, foot or lower extremity truma or other conditions that may affect the measurement of this study؛ previous use of orthoses؛ leg length discrepancy greater 5 mm؛ peripheral neuropathy due to disorders such as diabetes
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Teharan University of Medical Sciences
Street address
Tehran University of Medical Siences, Qods Aven., Keshavarz Blv., Tehran, Iran
City
Tehran
Postal code
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
IR.TUMS.REC.1394.1276
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
level of pain
Timepoint
on the day of inclusion in the study, 6th week, 12th week, 24th week
Method of measurement
Visual Analoge Scale (VAS)
2
Description
level of function
Timepoint
on the day of inclusion in the study, 6th week, 12th week, 24th week
Method of measurement
Oswestry Disability Index Questionnaire
Secondary outcomes
1
Description
Foot pain
Timepoint
at first visit, then every 4 weeks
Method of measurement
Question of subjects
Intervention groups
1
Description
Control group: one pair prefabricated foot orthoses made with polyester adjusting in to the size of the foot and fitting it into the shoes without change base of the foot mold. Instructions were given to the patients for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8h/day.
Category
Other
2
Description
Intervention group: one pair custom-made foot orthoses made with polypropylene from heel to just behind the metatarsal heads. Instructions were given to the participants for gradual wearing the foot orthoses to discomfort and after 2 weeks, at least, 8 h/day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Clinic, Sina Specialized & Subspecialty Hospital
Full name of responsible person
Maryam Mirshahi, MD, Sports Medicine Specialist
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq.,Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Sports and exercise department, Imam Khomeini Hospital
Full name of responsible person
Maryam Mirshahi, MD, Sports Medicine Specialist
Street address
Imam Khomeini Hospital, End of Keshavarz Blv, Tehran, Iran
City
Tehran
3
Recruitment center
Name of recruitment center
Sports Medicine Clinic, Sports Medicine Research Center
Full name of responsible person
Maryam Mirshahi, MD, Sports Medicine Specialist
Street address
No 7, Al-e-Ahmad Highway, Sports Medicine Research Center, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian, MD
Street address
Tehran university of Medical Science, Qods Aven., Keshavarz Blv., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sina Specialized & Subspecialty Hospital
Full name of responsible person
Maryam Mirshahi, MD
Position
Sports Medicine Specialist
Other areas of specialty/work
Street address
Sina Hospital, Imam Khomeini Ave., Hassan Abad Sq.,Tehran, Iran