The major goal of study is to evaluate impacts of Graston technique and Kaltenborn joint mobilization on pain, range and gait in pateints with plantar fasciitis.
Design
A single blinded quantitative study following the research design of randomized control trial.Randomization will be through lottery method.Active treatment group will be used to compare results.
Settings and conduct
Subjects with plantar fasciitis will be taken from these 3 clinics settings.Faisal hospital faisalabad,IDC physiofit faisalabad, Pro health rehab and medical center:participants will be blinded they will not aware whether they are in treatment group or in control group.participants will receive baseline treatment and Kaltenborn joint mobilization will be given to treatment group and participants will not aware of that.
Participants/Inclusion and exclusion criteria
Subjects having heel pain for more than 1 month, history of plantar discomfort in first few steps, pain with palpable soreness in medial tubercle of heel and positive windlass test will be included in the study.
Subjects having these conditions will be exclude-Previous lower or back surgery, trauma within six months, leg length difference, pregnancy,trasal tunnel syndrome,acute ankle sprain,achilles tendinopathy.
Intervention groups
Group A.Baseline treatment(ultrasound for 15 min and Graston technique)
Group B.Baseline treatment(ultrasound for 15 min and Graston technique)+Kaltenborn joint mobilization
Main outcome variables
Visual Analogue Scale for Pain
Goniometer for range of motions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230717058824N1
Registration date:2023-07-23, 1402/05/01
Registration timing:prospective
Last update:2023-07-23, 1402/05/01
Update count:0
Registration date
2023-07-23, 1402/05/01
Registrant information
Name
Sarwat Mehmood
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 305 7241745
Email address
sarwatmehmood1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-24, 1402/05/02
Expected recruitment end date
2023-08-24, 1402/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Kaltenborn joint mobilization along with Graston technique on pain and gait in patients with plantar fasciitis
Public title
Effect of Kaltenborn joint mobilization along with Graston technique on pain and gait in patients with plantar fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Heel pain for more than month
history of plantar discomfort in course of few steps
pain extended non weight bearing actions
history of pain in first few steps
pain with palpable soreness in medial tubercle of heel
Positive windlass test
Exclusion criteria:
Previous lower or back surgery
Trauma or fracture within six months
leg length difference more than 1 cm
use of corticosteroids within six months
pregnancy
not able to carry workout programme
Trasal tunnel syndrome,acute ankle sprains,calcaneal spurs,heel pad syndrome,achilles tendinopathy, patellofemoral syndrome
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Sample will be allocated to Group A(baseline treatment) and Group B(baseline +kaltenborn joint mobilization) randomly using lottery method.
Method of randomization is simple randomization.
Tool of randomization is lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants of both groups will be unaware whether they are in baseline group or treatment group after the informed consent.both groups will receive same baseline treatment and after that physiotherapist will apply kaltenborn joint mobilization to the group of which participants will be unaware of.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Faisalabad
Street address
4-Km Sargodha Road, University Town
City
Faisalabad
Postal code
38000
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
TUF/DR/MSPP/045
Health conditions studied
1
Description of health condition studied
Plantar fasciitis is a common heel pain condition, consititutes for 40-50% for all foot pain problems. It is due to over standing or due to over weight bearing at feet and condition is aggravated by physical activities like standing and weight bearing. Other associated symptoms are pain and soreness at plantar of foot. According to some researches PF can lead to micro injuries in the foot.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain in the foot will be primary outcome variable
Timepoint
Pain level will be measured before applying the intervention and then after 4 weeks after the completion of intervention.
Method of measurement
Visual Analogue Scale will be used to measure the pain.
2
Description
Range of motions at foot and ankle
Timepoint
Range of motions will be measured before applying the intervention and then after 4 weeks after the completion of intervention.
Method of measurement
Goniometer use to measure range of motions at ankle and foot.
Secondary outcomes
1
Description
Gait
Timepoint
Gait will be measured before applying intervention and after 4 weeks after the completion of intervention.
Method of measurement
Rivermead visual gait assessment
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisal Hospital, Faisalabad
Full name of responsible person
Medical Superintendent Faisal Hospital
Street address
673-A lower canal road East, peoples,s colony
City
Faisalabad
Postal code
38000
Phone
+92 41 8719679
Email
info@faisalhospital.com.pk
2
Recruitment center
Name of recruitment center
Physiofit IDC, Faisalabad
Full name of responsible person
Medical Superintendent
Street address
563-B, Satiana road, Peoples colony
City
Faisalabad
Postal code
38000
Phone
+92 41 8713737
Email
info@idc.net.pk
3
Recruitment center
Name of recruitment center
Pro health rehab and medical center
Full name of responsible person
Medical Superintendent
Street address
P-346 kashmir road, C block Amin town
City
Faisalabad
Postal code
38000
Phone
+92 331 1204747
Email
prohealthrehab47@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
dr. Sidra Majeed, PT
Street address
4-Km Sargodha road, University Town
City
Faisalabad
Postal code
38000
Email
sidra.majeed@tuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
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
The University of Faisalabad
Full name of responsible person
Sarwat Mehmood
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 29,block X, street no 3, madina town
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 305 7241745
Email
sarwatmehmood1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sarwat Mehmood
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 29,block X, street no 3, madina town
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 305 7241745
Email
sarwatmehmood1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Sarwat Mehmood
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 29,block X, street no 3, madina town
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 305 7241745
Email
sarwatmehmood1@gmail.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
All collected deindentified participant data set for the outcome measures.
When the data will become available and for how long
4 months after publication
To whom data/document is available
People working in the academic institutions.
Under which criteria data/document could be used
IPD and any additional supporting documents will be provided for the research on the similar topic and can be obtained by asking through the contact person mentioned below.