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.: PACTR202308802969500 Date of Approval: 24/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title shock wave therapy in heel pain
Official scientific title The effectiveness of radial extracorporeal shock wave therapy (rESWT) in plantar fasciitis: a12 month randomised controlled trial in a Tunisian rehabilitation department
Brief summary describing the background and objectives of the trial Plantar fasciitis, is the most common etiology of heel pain. Accoding to recent data, it affects about 10% of the population. It is present in both sedentary and athletes. Although it can occur at any age, it has the highest incidence between 40 and 60 years. It is estimated that one in 10 people will, at some point in their lives, have plantar fasciitis due to excessive stress and overweight. The therapeutic management is multidisciplinary including lifestyle measures, drug treatment, local cortisonic injections derivatives, rehabilitation and correction of static foot disorders with plantar insoles. In the absence of adequate treatment, the risk of transition to chronicity is significant with disabling functional consequences. Shockwave therapy is a medical alternative increasingly used in pathologies of the musculoskeletal system including plantar fasciitis. It could be an alternative to surgical management for chronic lesions that are resistant to physiotherapy, medications and cortisone injections. The objective is to evaluate the effectiveness of a six sessions of radial shock wave therapy in plantar fasciitis treatment considering pain and satisfaction. The secondary objective is to screen for foot disorders implementing baropodometry in a tunisian rehabilitation department over 12 months period
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/09/2022
Actual trial start date 01/11/2022
Anticipated date of last follow up 31/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group radial shock wave therapy 2000 pulses 10 HZ 2.5 Bar one session per week 6 weeks The patient laid down on the stretcher in supine position, without footwear, with the feet towards the shock wave towards the most painful heel point. The device probe was directly positioned on the heel with a conductive gel. 42
Control Group physiotherapy 3 session per week 12 sessions physiotherapy consisting of ultrasound TENS deep transverse massage and plantar fascia stretching 42 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
non rheumatic etiology Failure of medical treatment (analgesics and oral NSAIDs and at least one local cortisonic injection Untreated plantar fasciitis. Other associated tendinopathy. infection in the treatment area. Inflammatory cause tumor Previous operation on the heel Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 26/10/2022 ethics committee of the faculty of medicine of sousse
Ethics Committee Address
Street address City Postal code Country
street Mohamed Karoui 4002 sousse tunisia sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity with visual analog scale VAS at baseline 2 weeks one month 3 months 6 months 12 months
Primary Outcome the Modified Roles and Maudsley score baseline 3 months
Secondary Outcome peak plantar pressure in the dominant and non-dominant limbs baseline
Secondary Outcome mean plantar pressure baseline
Secondary Outcome total contact area baseline
Secondary Outcome heel contact area baseline
Secondary Outcome mass distribution baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
rehabilitation department Sahloul Hospital sahloul sousse 4054 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Hospital Sahloul sousse 4054 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sahloul hospital sahloul sousse 4054 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Sana Bhiri sahloul hospital sousse 4054 Tunisia
Dr Moncer Rihab Sahloul hospital sousse 4054 Tunisia
Dr Layouni Saoussen Sahloul Sousse 4054 Tunisia
Dr Sonia Jemni sahloul sousse 4054 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Iness Loubiri loubiri.iness@gmail.com +21699013775 mohamed farhat ouardanine
City Postal code Country Position/Affiliation
monastir 5010 Tunisia a specialist in the Rehabilitation Department of Sahloul Hospital
Role Name Email Phone Street address
Public Enquiries Rihab Moncer rihabmoncer@hotmail.com +21653911717 Sahloul Hospital
City Postal code Country Position/Affiliation
sousse 4054 Tunisia Rehabilitation department
Role Name Email Phone Street address
Scientific Enquiries Sana Bhiri bhirisana2902@gmail.com +21650416265 Sahloul Hospital
City Postal code Country Position/Affiliation
sousse 4054 Tunisia Department of Prevention and Security of Care
Role Name Email Phone Street address
Scientific Enquiries Saoussen Layouni saoussenlayouni@yahoo.fr +21652785163 sahloul
City Postal code Country Position/Affiliation
sousse 4054 Tunisia University Hospital Assistant in rehabilitation department
Role Name Email Phone Street address
Scientific Enquiries Sonia Jemni jemnisonia@hotmail.com +21699999169 sahloul
City Postal code Country Position/Affiliation
sousse 4054 Tunisia head of rehabilitation department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available and will be shared from 6 months following the publication. The statistical details will be shared six months after publication. Informed Consent Form,Statistical Analysis Plan,Study Protocol 6 months after publication and for tow years Access to the IPD and documents may be granted to individuals or entities engaged in scientific or scholarly research. Interested researchers or organizations must formally submit a request to loubiri.iness@gmail.com
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