Protocol summary

Study aim
To find out comparative benefits of Graston Technique and MET on the pain, foot and ankle impairment and temporospatial gait parameters i.e. cadence, gait speed, stride length, step width, stride time) in individuals with plantar fasciitis
Design
randomized clinical trial
Settings and conduct
Faisal hospital, Faisalabad  Allied hospital, Faisalabad
Participants/Inclusion and exclusion criteria
48 participants
Intervention groups
Group: A (n = 24) Ultrasound therapy, Graston technique and stretching exercises Group: B (n = 24) Ultrasound therapy, Muscle Energy Technique and stretching exercises
Main outcome variables
Pain Foot and ankle disability Temporosaptial gait parameter Cadence Step width Stride length Stride time Gait speed

General information

Reason for update
Acronym
Plantar Fasciitis, Graston Technique, Muscle Energy Technique
IRCT registration information
IRCT registration number: IRCT20230716058795N3
Registration date: 2024-07-25, 1403/05/04
Registration timing: retrospective

Last update: 2024-07-25, 1403/05/04
Update count: 0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Moater Iftikhar
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 301 6085203
Email address
moaterhassankazmi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-06, 1403/02/17
Expected recruitment end date
2024-08-07, 1403/05/17
Actual recruitment start date
2023-12-08, 1402/09/17
Actual recruitment end date
2024-05-06, 1403/02/17
Trial completion date
2024-05-27, 1403/03/07
Scientific title
COMPARATIVE EFFECTS OF GRASTON TECHNIQUE AND MUSCLE ENERGY TECHNIQUE ON PAIN AND TEMPOROSAPTIAL GAIT PARAMETERS IN PATIENTS WITH PLANTAR FASCIITIS
Public title
COMPARATIVE EFFECTS OF GRASTON TECHNIQUE AND MUSCLE ENERGY TECHNIQUE ON PAIN AND TEMPOROSAPTIAL GAIT PARAMETERS IN PATIENTS WITH PLANTAR FASCIITIS
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-50 years. Both genders Patients with unilateral or bilateral plantar fasciitis Pain in the heel for more than 3 month (chronic pain) History of heel pain after prolonged period of non-weight-bearing activity or first steps in the morning. On palpation at the medial tubercle of the heel, complain of pain and tenderness Pain that gets worse when walking or standing for a long time. Visual analogue scale at least 5 points for pain during the first few steps of walking in the morning. Positive windlass test. Signed informed consent.
Exclusion criteria:
Refusal to consent form  Recent accidental foot or ankle injury, previous lower-body surgical intervention within 6 months  Recent fractures in the lower limb (femur, tibia, fibula or foot bones) within 6 months  A leg length discrepancy of the 1 centimeters or greater  Diagnosed musculoskeletal disorders (rheumatoid arthritis, patellofemoral syndrome, calcaneal spurs)  Diagnosed neuropathy, local and systemic neurologic disorders (including sciatica, tarsal tunnel syndrome, nerve entrapment of abductor digiti minimi and posterior tibial)  Diagnosed posterior calcaneal spur, calcaneal stress fracture  Pregnancy  Received local steroid injection
Age
From 30 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 48
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is Randomized Clinical Trial. The patients are grouped into two groups. one intervention and other control
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
randomized clinical trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
the university of Faisalabad
Street address
Sargodha road
City
Faisalabad
Postal code
38000
Approval date
2024-05-06, 1403/02/17
Ethics committee reference number
TUF/Addl Reg/SB/386

Health conditions studied

1

Description of health condition studied
plantar Fasciatis
ICD-10 code
0J8R 0J8Q
ICD-10 code description
0J8R 0J8Q

Primary outcomes

1

Description
pain
Timepoint
before and after the 4 weeks of treatment period
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Foot and ankle disability
Timepoint
before and after the 4 weeks of treatment period
Method of measurement
Foot Function Index (FFI)

3

Description
gait parameters
Timepoint
before and after the 4 weeks of treatment period
Method of measurement
walking speed was measured by 4-meter walking test, and step and stride length was evaluated by measuring tape by taking foot prints

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: receiveved ultrasound then Graston technique and stretching exercises
Category
Treatment - Other

2

Description
Intervention group: received ultrasound, Muscle Energy Technique with stretching exercises
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
faisal hospital
Full name of responsible person
nabeel zahid
Street address
canal road
City
faisalabad
Postal code
38000
Phone
+92 333 6985203
Email
nabeelzahid@gmail.com

2

Recruitment center
Name of recruitment center
Allied hospital
Full name of responsible person
maria hafeez
Street address
daewo road
City
faisalabad
Postal code
38000
Phone
+92 333 7179508
Email
mariahafeez@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university off faisalabad
Full name of responsible person
Moater Iftikhar
Street address
sargodha road faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
MS thesis
Proportion provided by this source
10
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
Moater Iftikhar
Position
LECTURER
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
sargodha road
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
THE UNIVERSITY OF FAISALABAD
Full name of responsible person
MOATER IFTIKHAR
Position
LECTURER
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
SARGOSHA ROAD
City
FAISALABAD
Province
PUNJAB
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
THE UNIVERSITY OF FAISALABAD
Full name of responsible person
MOATER IFTIKHAR
Position
PUNJAB
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
SARGODHA ROAD
City
FAISALABAD
Province
PUNJAB
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@gmail.com

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
patient will
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Yes - There is 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
COMPARATIVE EFFECTS OF GRASTON TECHNIQUE AND MUSCLE ENERGY TECHNIQUE ON PAIN AND TEMPOROSAPTIAL GAIT PARAMETERS IN PATIENTS WITH PLANTAR FASCIITIS
When the data will become available and for how long
as soon as possible
To whom data/document is available
Readers
Under which criteria data/document could be used
specifications still not set
From where data/document is obtainable
Faisal Hospital Allied Hospital
What processes are involved for a request to access data/document
multiple
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