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.: PACTR202112901686623 Date of Approval: 07/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal spur patients: A Randomized Controlled Trial
Official scientific title Effect of Acetic Acid Shockwave Phonophoresis on Calcaneal spur patients: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The Low energy shockwave has a significant effect on the permeability of tissue. Consequently, it might be used to deliver a substance such as Acetic acid. Accordingly, Shockwave might help to improve the outcomes with calcaneal spur patients. Therefore, the present study might help in the treatment of calcaneal spur patient and also might improve the quality of life in a fast and efficient way.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESWT
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 30/04/2022
Actual trial start date
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet 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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Shock wave Therapy 6 sessions 6 weeks This group composed of subjects and represented the control group who will receive shock wave therapy 20 Active-Treatment of Control Group
Experimental Group Acetic acid shockwave phonophoresis therapy 6 sessions 6 weeks This group composed of subjects. They will take 6 sessions with Time between sessions 5-7 days plus exercise and dietary advice. 20
Control Group conventional physical therapy program 4 weeks 3 sessions per week Exercise program: a. Stretching exercise: -Standing calf-stretching exercise: stretching gastrocnemius & Soleus and Posterior Tibialis Muscle stretch muscle: In sitting and standing position for 15-30 seconds and repeat three times. -Towel stretch: stretching exercise for plantar fascia in sitting and standing position for 15-30 seconds (Repeat three times) - Ice bottle applied as home advice to stretch intrinsic foot muscles and analgesic effect. b. Strengthening exercise: -Some authors suggest that calcaneal length related to the dorsal and plantar flexor muscle strengths, which in turn affect the foot and lead to abnormal loading which increase the susceptibility for injury and pain (Sonu & Aman, 2015), (Büyükturan, 2017). - Towel pickup exercise to strengthen the intrinsic muscles of the foot - Marble pickups exercise: patients will be instructed to collect 10 marbles from the ground, by toes, and put it in a bowl and repeat it (3sets). - Calf raises exercises -Static and dynamic balance exercise. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Subjects included in this study will have all of the following criteria: - Heel pain with a calcaneal spur. - Calcaneal spur in a lateral calcaneal x-ray. - Patient’s age ranged from 30 to 65 years. - Patients with a calcaneal spur. - Patients with intact sensory perception. - At least 6 weeks from last corticosteroid injection; 4 weeks from the last local anaesthetic injection, iontophoresis, ultrasound, and electrotherapy Subjects excluded in this study for any of the following cases: - History of fracture or surgery of the heel or ankle. - Presence of inflammatory joint disease. - Marked osteoporotic patient. - Presence of ankylosing spondylitis or other inflammatory joint diseases. - Heart pacemaker use. - Patient on anticoagulant and coagulation disease. - Skin wound or ulcers. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 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 11/10/2020 research ethical committee at Faculty of physical therapy at Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432 Cairo 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome calcaneal spur length and width in (mm) pretreatment and post treatment
Secondary Outcome Pressure pain threshold (PPT): pretreatment and post treatment
Secondary Outcome Pain intensity level assessment: by visual analogue scale. pretreatment and post treatment
Secondary Outcome Activity of daily living: by Foot and Ankle Ability Measure (FAAM) scale pretreatment and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy outpatients clinic at Beni Suef university Qism Bani Sweif, Bani Sweif, Beni Suef Governorate Beni Suef Governorate 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moustafa Ali ELwan 6453 building- alhadaba alwasta - almokkatm Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Ali Elwan 3654 almokatm, Cairo, Egypt cairo Egypt self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Elwan mostafa.ali@pt.bsu.edu.eg 00201007351859 6453 building- alhadaba alwasta - almokkatm
City Postal code Country Position/Affiliation
Cairo Egypt assistant lecturer at beni suef university
Role Name Email Phone Street address
Scientific Enquiries FATMA SEDDEK prof.fatma.sedeek@cu.pt.edu.eg 00201223417697 Hasan Hamdy, Boulaq Ad Dakrour, Bolak Al Dakrour, Giza Governorate
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Physical Therapy Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Principal Investigator Nabil Mahmoud nabil.mahmoud@cu.edu.eg 00201200133613 Cairo
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Mostafa Elwan mostafa.ali@pt.bsu.edu.eg 00201007351859 3654 almokattm, cairo, Egypt
City Postal code Country Position/Affiliation
cairo Egypt beni suef university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the information collected during this study will be kept strictly confidential and used for research purposes only. Information obtained during this study is strictly confidential unless law requires disclosure. All data will be secured in a locked filing cabinet and in a password protected computer, to which only researchers will have access. Data will only be collected at beni suef University. Subject names will not be recorded or used in the reporting of information in publications or conference presentations. When the results are presented in research proceedings it will be presented as an aggregate. Individual participants will not be identifiable in any way. Informed Consent Form 2 years controlled for approval from principle investigator
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