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.: PACTR201911696023402 Date of Approval: 07/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The efficacy of Cross Friction versus Shockwave Therapy in the treatment of Plantar Fasciitis
Official scientific title The efficacy of Cross Friction versus Shockwave Therapy in the treatment of Plantar Fasciitis
Brief summary describing the background and objectives of the trial The plantar fascia can be a common site of heel pain. The natural history of plantar fasciitis is not yet well understood and can be difficult to distinguish from a patient who recovers spontaneously and who responds to treatment. A combination of cross friction, stretching, mobilisation and manipulation has been researched, but shockwave therapy has made its mark overseas and shows significant results in the treatment of plantar fasciitis.The aim of the study is to explore the comparative effect of cross friction with shockwave therapy in the treatment of plantar fasciitis in reducing the presenting symptoms.
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 Education /Training
Anticipated trial start date 03/02/2020
Actual trial start date
Anticipated date of last follow up 02/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Stopped early/ terminated
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 Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Cross friction 2 times a week for 5 minutes each session 3 weeks The most tender aspect of the plantar fascia will be cross friction massaged for 5 minutes 15
Experimental Group Shockwave 2 times a week The treatment settings will start at 2000 shocks, 2.5 bar, 10Hz around the most painful point on the plantar fascia 3 weeks The treatment settings will start at 2000 shocks, 2.5 bar, 10Hz around the most painful point on the plantar fascia 15
Control Group NOT APPLICABLE NOT APPLICABLE NOT APPLICABLE NOT APPLICABLE 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants must be between the age of 18 and 50 years of age. The pain experienced on the plantar aspect of the foot must be present for more than six weeks, rendering it chronic. Participants must be diagnosed with plantar fasciitis by another practitioner. Participants must have the following symptoms (Martin et al., 2014): Discomfort and pain on the lateral or the lower posterior aspect of the calcaneus or pain over the central band of the fascia. Pain on palpation of the proximal insertion of the plantar fascia. Pain on weight-bearing activities. Pain after prolong phase of non-activity or weight-bearing. Pain worsening on toe standing. Severe pain in the morning. The discomfort that gradually subsides in 30-45 minutes after initial steps after a period of inactivity. A reduction in ankle dorsiflexion. Participants must sign an information and consent form (Appendix A and B). This will ensure the understanding of the research procedures and the treatment protocol for the patient. Heel pain for less than 6 weeks rendering it acute. Participants with a history of any ankle, knee or hip surgery. Previous foot or ankle fractures. Patients who are being treated by any other practitioner for Plantar fasciitis as it will affect the results of the study. Participants who have received cortisone injections or using anti-inflammatory medication 3 weeks prior to the treatment period of the research. Lumbar spine radiculopathy of the nerve level of L5/S1. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 27/01/2020 University of Johannesburg Health Science Ethics Comittee
Ethics Committee Address
Street address City Postal code Country
55 Beit Street Johannesburg 2028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The possible outcome of the study may determine which treatment method might have the most significant effect on the plantar fascia. Both treatment methods can provide more knowledge about the condition as it is not fully understood yet. Reduction in symptoms of pain, stiffness, disability and activity modification affect by plantar fasciitis. Before the 1st, before the 4th and during the 7th consultation
Secondary Outcome The possible outcome of the study may determine which treatment method might have the most significant effect on the plantar fascia. Both treatment methods can provide more knowledge about the condition as it is not fully understood yet. If both treatments are as effective as each other in the treatment of plantar fasciitis it can possibly relieve the symptoms caused by plantar fasciitis. Before the initial, before the 4th and during the 7th consultation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Johannesburg Chiropractic Clinic 55 Beit Street Johannesburg 2028 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Johannesburg Health Science Ethics Committee 55 Beit Street Johannesburg 2028 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Johannesburg Health Science Ethics Committee 55 Beit Street Johannesburg 2028 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr. DM Landman 55 Beit Street Johannesburg 2028 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jenevieve Taljaard jenevieve96@gmail.com +27728647727 82 Aberdeen Street
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa Student
Role Name Email Phone Street address
Scientific Enquiries Irmarie Landman dirkiel@uj.ac.za +27115596820 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa Supervisor
Role Name Email Phone Street address
Public Enquiries Chris Yelverton chrisy@uj.ac.za +27115596646 55 Beit Street
City Postal code Country Position/Affiliation
Johannesburg 2028 South Africa HOD of Chiropractic
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Capturing Sheet Informed Consent Form,Statistical Analysis Plan,Study Protocol 5 years Anyone can request it, but it must be requested from the head of the department (HOD)
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