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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108493986992 Date of Approval: 30/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Radial Extra-Corporeal Shock Wave Therapy versus Myofascial Release Technique on Trigger Points of Planter Fasciitis
Official scientific title Extra-Corporeal Shock Wave versus Myofascial Release on Trigger Points of Plantar Fasciitis
Brief summary describing the background and objectives of the trial Planter fasciitis is multifactorial in etiology, with intrinsic and extrinsic causative factors. Intrinsic factors include age, excessive foot pronation, obesity and limited ankle dorsiflexion; extrinsic factors include occupational prolonged weight bearing, inappropriate shoe wear, and rapid increase in activity level. The purposes of this study is to investigate the significant effect of ESWT and MFR on TrPs of PF and showing which one of them is the most effective method for treatment of TrPs of PF.
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 01/09/2021
Actual trial start date
Anticipated date of last follow up 05/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group hot backs 15-20 minutes Intermittent stretching of 20 seconds will be used followed by 20 seconds rest for a total of 3 minutes for each stretching, the total self-stretching protocol lasting 3 minutes. 3 times per week for 6 weeks 6 weeks 15-20 minutes Intermittent stretching of 20 seconds will be used followed by 20 seconds rest for a total of 3 minutes for each stretching, the total self-stretching protocol lasting 3 minutes. 3 times per week for 6 weeks 15 Active-Treatment of Control Group
Experimental Group shock wave therapy 2 times per week for 6 weeks 6 weeks single application of 900 pulses follows, with energy around 0.13 mJ/mm2 with frequency of 4 pulses /s for 15-20 minutes 15
Experimental Group Myofascial release 3 times per week for 6 weeks 6 weeks Knuckles of the hand will be used to release the fascia from head of calcaneus in downward direction. Each session time will be 5 minutes (30 sec. release followed by 30 sec. rest) 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with PF of both genders (males and females) their age will range from (30 - 45) years old. 2. Recruited patients have history of planter heel pain for more than one month and having at least 3 active TrPs at planter fascia. 3. Patients willing and able to participate in the treatment program safely and without cognitive impairments that would limit their participation. 1. Pregnant women. 2. Patients having any dermatological disease within the field of ESWT application, peripheral arterial vascular disease, chronic lower limb and foot edema. 3. Flat foot to avoid misdiagnose. 4. Osteoarthritis in ankle joint. 5. Patients who received physical treatment for plantar heel pain in the previous 4 weeks. Adult: 19 Year-44 Year 30 Year(s) 45 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 12/12/2020 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat street bin srayat Giza . Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain threshold and tolerance assessed by Algometer pre and post intervention after 6 weeks
Secondary Outcome foot ROM assessed by Goniometer pre and post intervention after 6 weeks
Secondary Outcome Foot and Ankle Ability Measure pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Cairo University. 7 ahmed elzyat street bin srayat Giza . Egypt Giza 11411 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 77 shalhoub street ain shams cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 ahmed elzyat street bin srayat Giza . Egypt Cairo 11411 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Saleh marwa.saleh@hu.edu.eg 01146409675 30 Feisal street haram
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Physical Therapist specialist at Heliopolis university
Role Name Email Phone Street address
Public Enquiries Amr shalaby amr.saad@pt.cu.edu.eg 00201147718803 91 Ellebbine street, haram
City Postal code Country Position/Affiliation
Cairo Egypt lecturer of physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Marwa Saleh marwa.saleh@hu.edu.eg 00201146409675 30 Feisal street haram
City Postal code Country Position/Affiliation
Cairo Egypt Physical Therapist specialist at Heliopolis university
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) Statistical Analysis Plan,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