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.: PACTR202305760876973 Date of Approval: 05/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Influence of Low Level Laser Therapy Combined with Pelvic Floor Exercises in the Treatment of Post-Partum Coccydenia: A randomized Controlled Clinical Trial
Official scientific title Influence of Low Level Laser Therapy Combined with Pelvic Floor Exercises in the Treatment of Post-Partum Coccydenia: A randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Postpartum coccydynia is a painful condition that is felt in the coccyx area. Its prevalence in women is five times more than in men due to the risk of birth trauma as well as the longer and more posterior position of the bone. low level laser therapy is a modality that has been used by the medical profession for decades to treat acute and chronic pain conditions ranging from tendinitis and bursitis, to back pain and pelvic girdle pain. Pelvic floor therapy has been proposed as the first line of treatment for any pathology around pelvic area. so the purpose of this study is to investigate the influence of low-level laser therapy combined with pelvic floor exercises in the treatment of post-partum coccydenia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) LLLT PFE
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 30/04/2023
Actual trial start date 05/05/2023
Anticipated date of last follow up 20/07/2023
Actual Last follow-up date 01/08/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 45
Recruitment status Recruiting
Publication URL https://bfpt.springeropen.com/about
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group low level laser therapy and pelvic floor exercises 3 sessions per week 5 mints low level laser therapy plus 30 mints pelvic floor exercises, 3 sessions per week for 4 weeks Experimental group will be consisted of 15 postpartum women with coccydenia, they will be treated by low-level laser therapy and pelvic floor exercises.5 mints low level laser therapy plus 30 mints pelvic floor exercises, 3 sessions per week for 4 weeks 15
Control Group low level laser therapy only 3 sessions per week 5 mints per session , 3 sessions per week for 4 weeks this group contains 15 postpartum female with coccydynia, they will be treated with low level laser therapy for 5 mints , 3 sessions /week for 4 week 15 Active-Treatment of Control Group
Control Group pelvic floor exercises plus placebo low level laser therapy 3 sessions / week 30 mints pelvic floor exercises plus 5 mints placebo low level laser therapy /session , 3 sessions/week for 4 weeks this group contains 15 females with postpartum coccydynea, they will practice pelvic floor exercises for 30 mints in addition to 5 mints placebo low level laser /session , 3 sessions/week for 4 weeks 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age will be ranged from 20 -35 years 2- Body mass index not exceed 35 Kg/m². 3- Visual analogue scale score for coccydenia is equal to or greater than 3. 1- History of coccygeal injection or manipulation during the last two months 2- Systemic diseases (poor control diabetes, rheumatoid arthritis, etc.), 3- History of malignancy, coccygeal dislocation, acute fissure, 4- Any condition that interferes with LASER application. Adult: 19 Year-44 Year 20 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 11/12/2022 PT REC
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity through visual analogue scale at the beginning of the study and at the end of the treatment program
Secondary Outcome Range of motion of lumber spine through Schober test at the beginning of the study and at the end of the treatment program
Secondary Outcome Quality of life through Oswestery disability index questioner at the beginning of the study and at the end of the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out clinic of faculty of physical therapy Cairo university University street Giza 3455 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Afaf Mohamed Botla Gamal Abd Elnaser street Qalionia 1122 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy University street Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Yasser Ramzy Lasheen University street Giza 12613 Egypt
Dina M.A. Alhamaky University street Giza 12613 Egypt
Shreen Rashad Aboelmagd University street Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Afaf Botla drafafmohamed@cu.edu.eg 01283126608 Gamal abd el naser street
City Postal code Country Position/Affiliation
El Kanater El Khairia 1122 Egypt Associate Professor
Role Name Email Phone Street address
Public Enquiries Yasser Lasheen Dr_yasser_1977@cu.edu.eg 01005251562 University street
City Postal code Country Position/Affiliation
Giza 12613 Egypt Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Shreen Aboelmagd sherinefangary@cu.edu.eg 01002613262 University street
City Postal code Country Position/Affiliation
Giza 12613 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data obtained through this study will be provided to a qualified researcher who interested in this field and data that will be shared will be coded. approval of the request and execution of all applicable agreements will be a pre-request to the sharing of data Informed Consent Form,Statistical Analysis Plan,Study Protocol data requests can be submitted within 12 months after article publication and the data will be made accessible for up to 24 months 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 and execution of a data sharing agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://link.springer.com/journal/43161/volumes-and-issues 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