Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801002962139 Date of Approval: 10/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title pelvic girdle pain and exercises
Official scientific title Effect of segmental stabilizing exercises augmented by pelvic floor muscles training on postpartum pelvic girdle pain
Brief summary describing the background and objectives of the trial Pelvic girdle pain (PGP) ia a common problem in women during and after pregnancy. Approximately 20% of women have PGP during pregnancy. Although recovery occurs within 1 to 3 months after delivery, pain and disability may persist up to one year in 30% of women postpartum. PGP has a negative impact on many daily activities, capacity to participate in work and health-related quality of life. Few studies have investigated the effect of stabilizing exercises in women suffering from low back pain postpatum. Although pelvic floor muscles (PFM) are important components of the core muscles, they are not addressed in the previous studies. PFM are a primary contributor to lumbar satbility because their cocontraction with the abdominal muscles creates a back brace that decreases the load on the spine. This study aimed to investigate the effect of stabilizing exercise with or without PFM training on pain intensity, functional disability, trunk range of motion (ROM), and PFM strength in women postpartum.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,pelvic girdle pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/10/2014
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/01/2016
Actual Last follow-up date 01/01/2016
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 40
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computer software program Sealed opaque envelops Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group stabilizing exercises and pelvic floor exercises 3times/week 12 weeks PFM training protocol included rhythmic (contract and relax over one second) and sustained contractions (contract and hold for up to 10 seconds and relax). Each patient performed 10¿20 repetitions per set for 2 to 3 sets with an interval rest of 2 to 3 minutes. Repetition volume started at 30¿60 repetitions/day during weeks 1¿2; 60-120 repetitions/day during weeks 3¿4; and 120-150 repetitions/day 20
Control Group Stabilizing exercises 3 times/week 12 weeks Lumbar multifidus activation exercise and transverse abdominis drawing-in maneuver were performed. Time allocated for each muscle was 15 to 30 minutes for each muscle. Repetitions of each exercise started from 10 and increased to 15-20 repetitions. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Postnatal women with pelvic girdle pain. They experienced a positive sacroiliac joint provocation test and a positive active straight leg raising test. Their ages ranged from 25-35 years. Their body mass index (BMI) was 25-29.9 kg/m². The number of parity was not more than 2 times. low back pain caused by disc prolapse Spondylosis Lower limb deformity Previous surgery at back/lower limbs Stress/fecal incontinence Patients receiving medications or any physiotherapy treatment during the study course. 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 Research Ethical Committee, Faculty of Physical Therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
7Ahmed ElZayat st. Been Elsaryat Dokki, Giza, Egypt 12622 Egypt
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 31/08/2014 Research Ethical Committee, Faculty of Physical Therapy, Cairo University
Ethics Committee Address
Street address City Postal code Country
7Ahmed ElZayat st. Been Elsaryat Dokki, Giza, Egypt 12622 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain intensity At starting and after 12 weeks of treatment course
Primary Outcome Functional disability assessment At starting and after 12 weeks of treatment course
Primary Outcome Pelvic floor muscle strength At starting and after 12 weeks of treatment course
Secondary Outcome Trunk range of motion At starting and after 12 weeks of treatment course
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al-Azhar Hospital Nasr city Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
There is no funding resource
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abeer ElDeeb 7Ahmed ElZayat st., Been ElSarayat Dokki, Giza 12622 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Adly A. Sabbour 7Ahmed ElZayat st., Been ElSarayat Dokki, Giza 12622 Egypt
Khaled S. Ahmed 7 Ahmed ElZayat st., Been Elsarayat Dokki, Giza 12622 Egypt
Waled A. Ayad Nasr city, Al-Azhar University Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abeer ElDeeb beroeldeeb@yahoo.com +2 01001811588 7Ahmed ElZayat st., Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Public Enquiries Abeer ElDeeb beroeldeeb@yahoo.com +201001811588 7Ahmed ElZayat, Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Abeer ElDeeb beroeldeeb@yahoo.com +2 01001811588 7Ahmed ElZayat st., Been ElSarayat
City Postal code Country Position/Affiliation
Dokki, Giza 12622 Egypt Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University
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