The effect of designed orthosis based on dynamic plantar pressure distribution in patient with chronic plantar fasciitis: A randomized controlled trail.
Plantar fasciitis is one of the most common causes of heel pain. The chief complaint is typically a sharp pain in the inner aspect of the heel with the first few steps in the morning or after long periods of no weight-bearing. The main reason for the occurrence of this disorder is unknown. It is estimated to affect 10% of the general population during their lifetime. The prevalence of this disorder has been reported in middle age compared with other age range. Factors such as biomechanical, structural and environmental factors and systemic disease are suggested to be the main risk factors. Different surgical and non-surgical treatments are suggested in the management of this disorder. The purpose of this study will be to affect a new orthosis based on the plantar pressure distribution with night splint and current medication on pain, functional ability, quality of life, dynamic plantar pressure distribution and plantar fascia thickness in patients with plantar fasciitis in a randomized controlled clinical trial. Forty patients with plantar fasciitis referred to rehabilitation at the age range of 18 to 60 years (men and women) will be recruited. Following agreement, the initial assessment will be performed (plantar fascia thickness using ultrasonography, plantar pressure index using platform Emed, assessment of symptoms and functional limitations of the foot and ankle with foot and ankle outcome score); the patients will be randomly assigned into two groups through block-style randomization scheme: the experimental group (given medication with newly designed orthosis and night splint) and the control group (given medication and night splint). All data will be record again after four weeks of intervention. Descriptive statistics and Kolmogorov-Smirnov test will be used to analyze demographic data and to evaluate normality of data, respectively. Paired t-test and independent t-test will be used to assess within group and between groups changes. Pearson correlation coefficient will be employed to assess the relationship between different variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051717716N1
Registration date:2014-05-29, 1393/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Masoomeh Nakhaee
Name of organization / entity
Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0010
Email address
mnakhaee@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2014-06-05, 1393/03/15
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of designed orthosis based on dynamic plantar pressure distribution in patient with chronic plantar fasciitis: A randomized controlled trail.
Public title
The effect of orthosis in patient with chronic plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: early symptoms of chronic plantar fasciitis; age from 18 to 60 years old; no history of leg surgery; no systemic inflammatory diseases ( such as rheumatoid arthritis, ankylosing spondylitis, Reiter 's syndrome and diabetes); no foot fracture; no lower back pain with radicular pain; no deformity heels; no use nonsteroidal anti-inflammatory drugs in the last six months of physiotherapy to treat inflammation of the sheath foot plantar and untreated; no use of nonsteroidal anti-inflammatory drugs during the past six weeks, even for pain and inflammation in other parts of the body.
Exclusion criteria: failure to follow the treatment program during the study; inaccuracy in the implementation of the proposed treatment; use other treatments along with treatment designated in the study; it is diagnosed by the criteria above specialist.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Approval date
2013-08-03, 1392/05/12
Ethics committee reference number
5052/2
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fascial fibromatosis
Primary outcomes
1
Description
Plantar fascia thickness
Timepoint
Before entering the study - one month after intervention
Method of measurement
Ultrasonography application
2
Description
Pain
Timepoint
Before entering the study - one month after intervention
Method of measurement
Foot and Ankle Outcome Score (FAOS)-Pain Subscale
3
Description
Quality of Life
Timepoint
Before entering the study - one month after intervention
Method of measurement
Foot and Ankle Outcome Score (FAOS)- Quality of Life Subscale
4
Description
Function, Daily living
Timepoint
Before entering the study - one month after intervention
Method of measurement
Foot and Ankle Outcome Score (FAOS)-Function, daily living Subscale
5
Description
Maximum plantar pressure
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
6
Description
Maximum force
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
7
Description
Pressure-time integrals
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
8
Description
Force-time integral
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
9
Description
Contact area
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
10
Description
Arch Index
Timepoint
Before entering the study - one month after intervention
Method of measurement
Emed Platform
Secondary outcomes
1
Description
Height
Timepoint
Before entering the study
Method of measurement
Stadiometer
2
Description
Weight
Timepoint
Before entering the study
Method of measurement
Bathroom scales
3
Description
Body Mass Index
Timepoint
Before entering the study
Method of measurement
BMI Formula
4
Description
Standing Duration
Timepoint
Before entering the study
Method of measurement
Patient Self-report
5
Description
Direction of pain
Timepoint
Before entering the study
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: designed orthosis based on dynamic plantar pressure distribution + Night splint + Diclofenac 25mlgr, 3times per day (75 mlgr)
Category
Treatment - Devices
2
Description
Control group: Night splint + Diclofenac 25mlgr, 3times per days (75 mlgr)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Masoomeh Nakhaee
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research-University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Amir Massoud Arab
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research-University of Social Welfare and Rehabilitation 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
Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Masoomeh Nakhaee
Position
PhD Candidate
Other areas of specialty/work
Street address
Department of Orthotics and Prostheticsو University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0010
Fax
Email
mnakhaee@uswr.ac.ir, mnakhaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohammad Ali Mohseni Bandepi
Position
Physiotherapy/ PhD/ Professor
Other areas of specialty/work
Street address
Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
Phone
+98 21 2218 0039
Fax
Email
mohseni_bandpei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Masoomeh Nakhaee
Position
PhD Candidate
Other areas of specialty/work
Street address
Department of Orthotics and Prosthetics, University of Social Welfare and Rehabilitation Sciences, Kodakyar Ave., Daneshjoo Blvd., Evin.
City
Tehran
Postal code
Phone
+98 21 2218 0010
Fax
Email
mnakhaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)