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.: PACTR201803003232225 Date of Approval: 20/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title effect of core stability exercise on postpartum lumbopelvic pain : A randomized controlled trial
Official scientific title assessment of postpartum lumbopelvic pain after core stability exercise
Brief summary describing the background and objectives of the trial Persisrance lumbopelvic pain can negatively impact the activity of daily living activity. Strengthening and neuromuscular reeducation of the core musculature is thought to play a significant role in restoring stability to the spinal column and in turn minimizing pain associated instability. So the purpose of this randimized controlled study is to investigate the effect of core stability exercise on postpartum lumbopelvic pain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) No
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Pregnancy and Childbirth,women with postpartum lumbopelvic pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 24/03/2018
Actual trial start date 31/03/2018
Anticipated date of last follow up 15/05/2018
Actual Last follow-up date 15/05/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 34
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group core stability ex Plus ultrasound and infrared 18 session day after day 6 weeks core stability exercise and application of ultrasound after application of infrared to the low back area 17
Control Group ultrasound and infrared 18 session day after day 6 weeks application of infrared followed by application of ultrasound on low back area 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Forty multi-parus females, suffering from lumbopelvic pain (pain at the lower back and pelvic girdle) after at least three months till one year postpartum participated in this study. Their ages ranged from (25-35) years, parity (2-4) and their body mass index did not exceed 35 Kg/m2, the participants are positive for both (active straight leg raise (ASLR) & posterior pelvic pain provoking test ( 4P test)). Patient will be excluded if the have: Systemic inflammatory diseases, serious cardiovascular disease, diagnosed psychiatric disease, recent surgery, prolapsed disc, spondylolisthesis,, fractures, tumors, infections, osteoporosis and pregnancy were excluded. 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 11/03/2018 Ethics committee of the faculty of physical therapy, cairo university
Ethics Committee Address
Street address City Postal code Country
7 Ahmed EL Zayat Street, Doki Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurement of pain pressure threshold using pressure algometer Pre and post treatment
Primary Outcome measurement of pain pressure threshold using pressure algometer Pre and post treatment
Primary Outcome measurement of pain pressure threshold using pressure algometer Pre and post treatment
Secondary Outcome measurement of pain intensity by visual analouge scale and measurement of functional ability by oswestry disability index Pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy, cairo university 7 Ahmed EL-Zayat Street, Doky Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Physical therapy, cairo university 7 Ahmed EL Zayat Street, Doki Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical therapy, cairo university 7Ahmed El Zayat Street, Doki Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
dr/ Marwa shafiek Mustafa saleh 6 October Bola El Dakror Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marwa Saleh marwa_shafiek2000@yahoo.com 01008342466 6 October Bola El Dakror
City Postal code Country Position/Affiliation
Giza Egypt lecturer at basic science department, Faculty of Physical therapy, cairo university
Role Name Email Phone Street address
Public Enquiries Afaf Botla drafafmohamed@yahoo.com 01283126608 Sendapeace Gamal And El Nader Street
City Postal code Country Position/Affiliation
Al Qaliobia Egypt lecturer at women health department, Faculty of Physical therapy, cairo university
Role Name Email Phone Street address
Public Enquiries Noran El Behary noranelbehary@yahoo.com 01010619952 8 A Helwsn street El Laser El einy
City Postal code Country Position/Affiliation
Giza Egypt lecturer at basic science department, Faculty of Physical therapy, cairo university
Role Name Email Phone Street address
Scientific Enquiries Marwa Saleh marwa_shafiek2000@yahoo.com 01008342466 6 Bola El Dakror
City Postal code Country Position/Affiliation
Giza Egypt lecturer at basic science department, Faculty of Physical therapy, cairo university
REPORTING
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