My study aim is to assess the effectiveness of Graston technique with taping on the treatment of chronic plantar heel pain, foot function and foot health related quality of life of chronic plantar fasciitis patients.
Design
Randomized, parallel groups, single blinded, randomized controlled trial
Settings and conduct
Medina Teaching Hospital, participants will be blinded so that they can not know either they will be in intervention group or in control group
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients will be diagnose with chronic plantar fasciitis and Pain started before more than 6 weeks and less than 6 months
Both gender age of 20 to 45 years were included
Pain on first steps of walking out of bed in the morning or after prolonged standing, or sitting
Pain located at the anterio- medial surface of heel or mid-foot and presence of an everted calcaneus greater than or equal to 2
Exclusion criteria
No Previous history of severe vascular disease, cancer, joint disease, neurological disorders related to lower limb of affected side and pathological calcaneal spur
Ankle and foot fracture or surgery before 6 months and stress fracture before 8 months
Plantar having fascia release surgery done within 3 month back
Diabetics and altered skin sensation or foot dermal conditions
Who are already taking physical therapy treatment or any other treatment during 30 days of participation
Pregnant female
Who refuse to participate in the study
Intervention groups
There will be one treatment group and one control group. 30 participants will include by randomization into treatment group and control group. 15 individuals will include into the treatment group which will GT group, 15 individuals will include into the control group which will control group randomly.
Main outcome variables
plantar heel pain, Foot function and General foot health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210111050005N1
Registration date:2021-02-01, 1399/11/13
Registration timing:registered_while_recruiting
Last update:2021-02-01, 1399/11/13
Update count:0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Noreen kiran
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 5212044
Email address
noreen.kiran@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-30, 1399/11/11
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Graston technique treatment on Pain, and Foot General Health of chronic Plantar Fasciitis patients
Public title
Effectiveness of Graston technique treatment on chronic plantar Fasciitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with chronic plantar fasciitis
Patients having pain started before more than 6 weeks and less than 6 months
Both male and female of age 20 to 45 years were included
Patients having pain on first steps of walking out of bed in the morning or after prolonged standing, or sitting
Patients having pain located at the anterio- medial surface of heel or mid-foot and presence of an everted calcaneus greater than or equal to 2
Exclusion criteria:
Patients having previous history of severe vascular disease, cancer, rheumatoid arthritis, or osteoporosis, neurological disorders related to lower limb of affected side, pathological calcaneal spur
Patients having Ankle and foot soft tissue masses/bursitis, tendon pathology or scar, heel fat pad atrophy/hypertrophy
Patients having Ankle and foot fracture or surgery before 6 months and stress fracture before 8 months
Patients having pain or foot related complications after fracture or surgery
Patients having fascia release surgery done within 3 months back
Patients having Diabetics and altered skin sensation or foot dermal conditions
Who are already taking physical therapy treatment or corticosteroid injections and who were not willing to quit such treatment during 30 days of participation
Pregnant female
Who refuse to participate in the study
Age
From 20 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient of heel pain coming to the recruitment center will be screened. I will make a list of 30 patients according to the sequence as they are coming I will be give them numbers 1 to 30 i.e. the first patient enrolled will be given number 1 and last patient enrolled will be given number 30. Every odd will be allocated into treatment group and every even number will be allocated into control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
I will give each participant a number, e.g 1 to 30, on the basis of these numbers i will make two groups, one will be treatment group in which all even numbers will be allocated, and one will control group in which all odd numbers will be allocated. In this way this way i could not know which participant will be in which group and participant will also not know who will be entered in which group.
Placebo
Not used
Assignment
Other
Other design features
Objective 1= To assess the effectiveness of Graston technique with taping on the treatment of chronic plantar heel pain in chronic plantar fasciitis patients, Objective 2= To assess the effectiveness of Graston technique with taping on foot function and foot health related quality of life of chronic plantar fasciitis patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of The University of Fiasalabad
Street address
Medina University near kea motors showroom, Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2020-08-03, 1399/05/13
Ethics committee reference number
TUF/DR/MSPP/005
Health conditions studied
1
Description of health condition studied
Plantar fasciitis. Overloading and repetitive micro trauma results plantar fasciitis This is a health condition not a disease.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before intervention, and 2, 4 weeks after intervention
Method of measurement
by using plantar fasciitis pain scale
Secondary outcomes
1
Description
General foot health status
Timepoint
before intervention and 2, 4 weeks after intervention
Method of measurement
by The Foot Health Status Questionnaire
Intervention groups
1
Description
It will receive baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ) and Graston technique by Graston tool. treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015). Graston technique= First of all Graston technique lubricant will be applied on plantar surface of foot. For 8 minutes sweeping strokes will applied start from meta-tarsals to calcaneus then from calcaneus to meta-tarsal. For this purpose Graston tool to mobilize the soft tissue will be used. The area where high restriction of the soft tissue will present, aggressive Graston treatment with increase force and shorter strokes on that area will applied. Patients will be monitored if there is an increase in pain or discomfort during whole treatment (Jones et al., 2010).
Category
Treatment - Other
2
Description
It will receive only baseline treatment (Therapeutic ultrasound, stretching exercises of calf and plantar fascia, taping ). treatment will be of 2 sessions per week ( every 3rd day) for 4 weeks. Ultrasaound protocol= Therapeutic ultrasound was given to the patients for 5 minutes(continuous mode, intensity of 1 W/cm2 with frequency of 1 MHz for five minutes in prone lying (Sankhe, et al., 2016). Stretching exercises of calf and plantar fascia= Stretching exercises of plantar fascia muscle and calf muscles, performed 10 stretches holding each for 10 seconds (DiGiovanni et al., 2006, Garret and Neibert, 2019). Taping mechod= low dye taping with calcaneal sling technique will be used. leukotape (type of tape) will be used for this purpose. taping will be apllied on every 3rd day of week, after application patient will will be guided to remove tape after 24 hours (Hyland et al., 2006, Weon, Kim and Jung, 2015)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Madina teaching hospital
Full name of responsible person
Dr Kishwar
Street address
Medina Teaching hospital near kea motors showroom, Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8869861
Email
kishwarmth@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aisha tabassum
Street address
Medina University near kea motors showroom, Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
Aisha.tabassum@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
2
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
Noreen kiran
Position
Demonstrator
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
P176, Namat colony no 2, street no 6, near khuram chock, jaranwala road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
011925212044
Email
Noreen.kian@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Noreen Kiran
Position
Demonstrator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Muslim town 3, street number 09, Sargodha road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 5212044
Fax
Email
Noreen.kiran@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Noreen Kiran
Position
Demonstrator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Muslim town 3, street number 09, Sargodha road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 5212044
Fax
Email
Noreen.kiran@tuf.edu.pk
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