Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204745326931 Date of Registration: 04/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GRASTON TECHNIQUE VERSUS POSITIONAL RELEASE TECHNIQUE IN PATIENTS WITH CHRONIC PLANTAR FASCIITIS
Official scientific title GRASTON TECHNIQUE VERSUS POSITIONAL RELEASE TECHNIQUE IN PATIENTS WITH CHRONIC PLANTAR FASCIITIS.
Brief summary describing the background and objectives of the trial BACKGROUND: Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older more sedentary individuals (Neufeld & Cerrato, 2008). It results from a chronic overload of the plantar fascia. It can be due to overuse, as seen in runners and military personnel, or due to excessive loading, as seen in obese (body mass index >30) sedentary individuals and those who stand for prolonged periods of time (Abbassian et al., 2012). The Purposes of this study will be: 1. To compare the effect of the Graston technique VERSUS positional release technique on pain pressure threshold in patients with chronic plantar fasciitis. 2. To compare the effect of the Graston technique VERSUS positional release technique on ankle dorsiflexion and plantarflexion range of motion in patients with chronic plantar fasciitis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 04/05/2022
Actual trial start date
Anticipated date of last follow up 04/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Graston technique 4 weeks and twice treatment will be given per week Graston technique in addition to traditional treatment (stretching of the plantar fascia, stretching of calf muscle and short-foot exercise) 20
Experimental Group positional release technique 4 weeks and two sessions will be given per week positional release technique in addition to traditional treatment (stretching of the plantar fascia, stretching of calf muscle and short-foot exercise). 20
Control Group traditional treatment 4 weeks and two sessions will be given per week traditional treatment (stretching of the plantar fascia, stretching of the calf muscle, and short-foot exercise) 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: 1. Clinically diagnosed cases of plantar fasciitis not less than 3 months. 2. Heel pain felt maximally over the plantar aspect of the heel. 3. Pain in the heel on the first step in the morning. 4. Their ages range from 30 to 50 years (Riddle & Schappert, 2004). 5. Body mass index range from (18.5 to 24.9 kg/m2) (Tas et al.,2017) Exclusion criteria: 1. Subjects can‘t tolerate close physical contact (Kotwalkar et al., 2019). 2. Athletes. 3. Subjects with skin infections (Kotwalkar et al., 2019). 4. Subjects with a recent fracture with an incomplete bony union (Rowlett et al., 2018). 5. Subjects with acute inflammatory or infectious process (Rowlett et al., 2018). 6. Subjects with hematoma (Rowlett et al., 2018). 7. Subjects with osteoporosis (Looney et al., 2011). 8. Subjects with foot deformity (Kotwalkar et al., 2019). 9. Subjects that take medications that may increase blood clotting (Kotwalkar et al., 2019). 10. Surgery to the ankle or foot (Looney et al., 2011). Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/02/2022 faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street Giza Giza 11311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A pressure Algometer. will be used to evaluate plantar heel tenderness, with the unit of measurement in kg/cm². before and after intervention.
Secondary Outcome Digital Goniometer to measure ankle dorsiflexion and plantarflexion range of motion. before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo university 7 ahmed elzyat street Giza 11311 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rania Nagy Karkousha 31 port said street Cairo 11511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy 7 ahmed elzyat street Cairo 11311 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Nagy Karkousha rania.nagy@pt.cu.edu.eg 01227244630 31 port said street
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Assistant Professor Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Neveen AbdelLatif AbdelRaoof dr_neveen_69@yahoo.com 01064615553 12 Mourad street
City Postal code Country Position/Affiliation
Giza Egypt Professor and Vice Dean of faculty of physical therapy for Education and students Affairs Cairo university
Role Name Email Phone Street address
Scientific Enquiries Doaa Said Mohamed doaasallam_p.t@hotmail.com 01228410331 7 maadi street
City Postal code Country Position/Affiliation
Cairo Egypt Physical Therapy specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Informed Consent Form,Study Protocol 12 months period time after publication Controlling access to data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information