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.: PACTR202206727183355 Date of Approval: 21/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF SHOCK WAVE ON POSTNATAL COCCYDYNIA
Official scientific title EFFECT OF SHOCK WAVE ON POSTNATAL COCCYDYNIA
Brief summary describing the background and objectives of the trial Coccydynia, refers to pain in the region of the coccyx. This condition can lead to chronic pain and functional impairment, limiting the quality of life of the patients. Patients usually complain of pain while sitting, which worsens when rising from a seated position and leaning back while seated. Some patients also experience coccygeal pain with sexual intercourse or defecation, and females can have exacerbation during vaginal delivery or during the premenstrual period. So, the aim of this study is to investigate the effect of shock wave on postnatal coccydynia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BMI VAS MMST NSAIDs ESWT
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 15/06/2022
Actual trial start date 30/06/2022
Anticipated date of last follow up 30/09/2022
Actual Last follow-up date 30/10/2022
Anticipated target sample size (number of participants) 55
Actual target sample size (number of participants) 46
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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Ibuprofen 400 mg twice daily for 2 weeks all patients will take 400 mg Ibuprofen twice daily for 2 weeks. 23 Active-Treatment of Control Group
Experimental Group shock wave 1 session per week for four weeks Each patient will receive 2000 shots of Shock wave therapy in the coccyx area per session. The frequency is 5 Hz and the pressure is 3–4 bars.1 session per week for 4 weeks. plus of shock wave they will take 400 mg of Ibuprofen twice daily for 2 weeks. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Their ages will range from 25-35years. • All women will be diagnosed as postnatal coccydynia by a physician. • BMI will be less than 35 kg/m². • Parity will be ranged from 1-3 times. • Pregnancy • Fracture or dislocation of the coccyx. • Patients with psychiatric illness. • Recent pelvic or colorectal surgery. • Peri-anal conditions. • Genitourinary incontinency. • local tumors or infection of the sacrococcygeal region. • Cauda equina tumors. • Patients with preexisting chronic pain conditions (e.g., fibromyalgia and polymyalgia rheumatica) will be excluded. Adult: 19 Year-44 Year 25 Year(s) 35 Year(s) Female
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 05/12/2021 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat St. Bien Elsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain severity will be measured by visual analouge scale and pressure algometer. at the begining of the study and at the end of the study after 4 weeks.
Secondary Outcome Functional disability will be measured using Oswestry disability questionnaire. at the begining of the study and at the end of the study after 4 weeks.
Secondary Outcome Lumbar range of motion using the modified-modified Schober Test (MMST) at the begining of the study and at the end of the study after 4 weeks.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Agouza Police Hospital Nile Street Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dina Saeed Mohammed Mohammed Alfardoos Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FACULTY OF PHYSICAL THERAPY UNIVERSITY STREET Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dina Saeed Mohammed Mohammed Alfardoos Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Mohammed dinapt00@gmail.com 00201117713440 alfardoos. 6 october
City Postal code Country Position/Affiliation
Giza Egypt Ms.
Role Name Email Phone Street address
Public Enquiries Sohier Elkosery d_elkosery@yahoo.com 00201100691280 Embaba
City Postal code Country Position/Affiliation
Giza Egypt Prof.
Role Name Email Phone Street address
Public Enquiries Dina Mohammed dinapt00@gmail.com 00201117713440 alfardoos. 6 october
City Postal code Country Position/Affiliation
Giza Egypt Ms.
Role Name Email Phone Street address
Scientific Enquiries Dina Mohammed dinapt00@gmail.com 00201117713440 alfardoos. 6 october
City Postal code Country Position/Affiliation
Giza Egypt Ms.
Role Name Email Phone Street address
Scientific Enquiries Afaf Botla drafafmohamed@cu.edu.eg 00201283126608 Al Qaliobia, Al Qanater Al Khayria, Sendpeace, Gamal Abd Al Naser street
City Postal code Country Position/Affiliation
Al Qaliobia 1122 Egypt Dr.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in shock wave therapy. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://bfpt.springeropen.com/ 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