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.: PACTR202004672785790 Date of Approval: 16/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Deep friction massage for treatment of plantar fasciitis
Official scientific title Deep Friction Massage Versus Local Steroid Injection for Treatment of Plantar Fasciitis: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial deep transverse friction massage (DFM)has long been reported to be effective in treatment of some tendonopathies. The objective of this study is to evaluate the efficacy of DFM for treatment of 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 01/06/2019
Actual trial start date 01/06/2019
Anticipated date of last follow up 15/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group deep transverse friction massage 10 minutes session every other day seven sessions through two weeks with the reinforced thumb, a friction massage was applied transversely across the plantar fascia from proximal to distal on the most tender point in a rate of about 2 to 3 cycles per second within the patient's tolerance. this procedure was done by a well trained nurse in the physiotherapy unit. 30
Control Group local steroid injection 40mg triamcinolone acetonide/1ml. plus lidocaine 1%/ 1ml. once at the beginning of the study Using the blind medial approach towards the medial calcaneal tubercle, 40mg triamcinolone acetonide/1ml. plus lidocaine 1%/ 1ml. locally injected with 1.5 inch 23 gauge needle in complete aseptic condition. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- adult patients >18 years old 2- chronic plantar fasciitis 3- acceptance of participation 1- patients with diabetes mellitus, peripheral vascular disease and those who previously received systemic or local steroid injection within three months or locally injected with any other material. 2- Those who had rheumatic or connective tissue diseases or Achilles tendinopathy. 3- Patients with foot pain due to arthritis, trauma, infection or neurological problem and those with previous surgical intervention in the heel. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 10/05/2019 Al Azhar University Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
1 Al Azhar University Square, Knig Faisal St. Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual Analogue Scale for Pain. At bseline then at two and six weeks
Secondary Outcome foot function index 0, 2 and 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Rheumatology and Rehabilitation Clinics at Al Azhar University 1 Al Azhar University Squre Assiut Egypt
Rheumatology and Rehabilitation Clinic Sohag University hospital 3 The University st. Sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelhafeez Moshrif and Mohamed E Sayed 1 Al Azhar University Square, King Faisal st. Assiut 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abdelhafeez Moshrif 1 Al Azhar University Squre Assiut Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamed S. Elwan 1 Al AZhar University Square Assiut Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelhfeez Moshrif dr.moshrif@azhar.edu.eg 00201062930120 1 Al Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer of Rheumatology and Rehabilitation
Role Name Email Phone Street address
Public Enquiries Hanan Ahmed hanan.ahmed@gmail.com 00201006425746 3 ElGamaa st.
City Postal code Country Position/Affiliation
Sohag Egypt Senior University officers
Role Name Email Phone Street address
Scientific Enquiries Mohamed Sayed drelwan77@yahoo.com 00201093105199 1 Al Azhar University Square
City Postal code Country Position/Affiliation
Assiut Egypt Lecturer of Rheumatology and Rehabilitation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results of the study after de identification as text, tables and figures. Clinical Study Report,Statistical Analysis Plan Just after publication of the study. no end date Any researcher who want to access the data provided having a sound proposal.
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