To determine the effects of mobilization with movement and Maitland grade III mobilization on
pain and physical function in plantar fasciitis.
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
This study will be conducted at Riphah Rehab Clinic.The treatment will be given for a total of 4 weeks.2 sessions given in each week. The outcome measure will be measured at baseline and after 4 weeks.Outcome assessor will be blinded. After taking informed written consent. Allot a distinct identification number and placed all written consent forms in locker to blind assessor.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
1. Age: 30-60 years
2. Both male and female patients with chronic plantar fasciitis
3. Tender medial side of the calcaneus on palpation
4. Pain occur on insertion of the plantar fascia by palpation
5. Pain occur in weight-bearing activities
6. Positive results of windlass test
7. Negative results of tarsal tunnel test
EXCLUSION CRITERIA:
1. Patient having any arthritis such as rheumatoid arthritis,
reactive arthritis
2. Tumor
3. Fracture of tarsals and metatarsals
4. Tarsal tunnel syndrome
5. Any recent surgery of ankle and foot
Intervention groups
Intervention of group A=Mobilization with movement, Gastrocnemius stretching, Stretching of Plantar fascia, Ultrasound Therapy.
Intervention of group B=Maitland grade III mobilization, Gastrocnemius stretching, Stretching of Plantar fascia,Ultrasound Therapy
Main outcome variables
Numeric pain rating scale, Foot and ankle ability
measure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046541N1
Registration date:2020-08-16, 1399/05/26
Registration timing:registered_while_recruiting
Last update:2020-08-16, 1399/05/26
Update count:0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
Fatima Mazhar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 37284283
Email address
drfatimamazhar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-11-30, 1399/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Mobilization with Movement and Maitland grade III Mobilization on pain and physical function in plantar fasciitis.
Public title
Effects of Mobilization with Movement and Maitland grade III Mobilization on pain and physical function in plantar fasciitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: 30-60 years
both male and female patients with chronic plantar fasciitis
tender medial side of the calcaneus on palpation
pain occur on insertion of the plantar fascia by palpation
pain occur in weight-bearing activities
positive results of windlass test
negative results of tarsal tunnel test.
Exclusion criteria:
patient having any arthritis such as rheumatoid arthritis, reactive arthritis
tumor
fracture of tarsals and metatarsals
tarsal tunnel syndrome
any recent surgery of ankle and foot
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assign randomly in group A and group B by computer-generated random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded study.Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation due to the nature of the intervention neither participants nor staff can be blinded to allocation.After taking informed written consent. Allot a distinct identification number and placed all written consent forms in locker to blind assessor.Assessor can analyze data without having information about the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee (REC), Riphah College of Rehabilitation
Street address
28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore.
City
Lahore
Postal code
54000
Approval date
2641-04-28, 2020/02/08
Ethics committee reference number
REC/RCRS/20/1032
Health conditions studied
1
Description of health condition studied
Plantar fasciitis
ICD-10 code
M72.2
ICD-10 code description
Plantar fasciitis
Primary outcomes
1
Description
Pain
Timepoint
Before treatment and 4 weeks after completion of intervention
Method of measurement
Numeric pain rating scale (NPRS)
Secondary outcomes
1
Description
Physical function
Timepoint
Before treatment and 4 weeks after completion of intervention
Method of measurement
Foot and ankle ability measure (FAAM)
Intervention groups
1
Description
Intervention group: Mobilization with movement, gastrocnemius stretching, stretching of plantar fascia and ultrasound therapy
Category
Treatment - Other
2
Description
Intervention group: =Maitland grade IIImobilization, gastrocnemius stretching, stretching of plantar fascia and ultrasound therapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Riphah rehab center,Lahore Pakistan
Full name of responsible person
Muhammad Hashim
Street address
393-D3 wapda town Lahore
City
Lahore
Postal code
54770
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate , Kot Lakhpat,Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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