Trial no.:	PACTR201811706770691	Date of Approval:	23/11/2018
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Effect of pelvic floor exercise on female with low back pain

Official scientific title

Effect of pelvic floor exercise combined with core stabilization exercise on females with non-specific low back pain. A randomized controlled trail

Brief summary describing the background and objectives of the trial

Background: The prevalence of non-specific low back pain (LBP) is high in female versus male at different age decades. The pelvic floor muscle dysfunction is associated with the development of LBP. Objective: To investigate the effect of core stabilization exercise included pelvic floor exercise in females with non-specific LBP compared to core stability exercise without pelvic floor exercise.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Musculoskeletal Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Rehabilitation

Anticipated trial start date

01/10/2018

Actual trial start date

31/10/2018

Anticipated date of last follow up

31/01/2019

Actual Last follow-up date

31/01/2019

Anticipated target sample size (number of participants)

76

Actual target sample size (number of participants)

48

Recruitment status

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 a randomization table created by a computer software program	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Core stability exercises combined with pelvic floor exercise and physical therapy agents	Each exercise of core stability exercises repeated 10 time for 6 weeks, Pelvic floor muscle exercise for 6sec followed by rest for 6sec, resulting in 5 contraction cycles/min Transcutaneous electrical nerve stimulation (TENS), continuous ultrasound and infra-red irradiation. Following infra-red irradiation for 20 min at a 40 cm distance for the low back region 3 session/week	20 min Core stability exercises 15 min Pelvic floor muscle exercise 30 min physical agents	Core stability exercise (pelvic elevation (bridging), abdominal training (curl-ups), mixed extension/flexion stretch of the spinal column (cat-camel), hook-lying (posterior pelvic inclination), etc. in addition to exercises on unstable support (Swiss Ball), in order to improve proprioception, coordination and balance). Pelvic floor muscle exercise program; this exercise was based on contraction of the pelvic floor muscles for 6sec followed by rest for 6sec, resulting in 5 contraction cycles/min. The number of contraction cycles was increased over the 6-week treatment period: week 1, 25 cycles/day (5 min total); week 2, 50 cycles/day (10 min total); week 3, 75 cycles/day (15 min total); weeks 4-6, 100 cycles/day (20 min total). Physical therapy agents; TENS was administered at a frequency of 80 Hz with 10-30 mA intensity for 30 min. Four surface electrodes, 5×5 cm each, were placed over the painful area in the lumbar region, TENS was delivered using Intelect Advanced (REF2773MS; Chattanooga: Mexico). The intensity of TENS was adjusted to produce a tingling sensation that was approximately 2-3 times the patient’s sensory threshold. The continuous ultrasound (1MHz continuous at 1.2 W/cm2 for 5 min) using Metron Accusonic Plus .	38
Control Group	Core stability exercises combined with physical therapy agents	Each exercise of core stability exercises repeated 10 time for 6 weeks, Transcutaneous electrical nerve stimulation (TENS), continuous ultrasound and infra-red irradiation. Following infra-red irradiation for 20 min at a 40 cm distance for the low back region 3 session/week	20 min Core stability exercises 30 min physical agents	Core stability exercises; the CSE was performed in standing, sitting, kneeling and lying positions. During the exercises, the patients were trying to keep their trunk and pelvic girdle inactive. The program consisted of different sets of exercises such as: pelvic elevation (bridging), abdominal training (curl-ups), mixed extension/flexion stretch of the spinal column (cat-camel), hook-lying (posterior pelvic inclination), etc. in addition to exercises on unstable support (Swiss Ball), in order to improve proprioception, coordination and balance. Physical therapy agents; TENS was administered at a frequency of 80 Hz with 10-30 mA intensity for 30 min. Four surface electrodes, 5×5 cm each, were placed over the painful area in the lumbar region, TENS was delivered using Intelect Advanced (REF2773MS; Chattanooga: Mexico). The intensity of TENS was adjusted to produce a tingling sensation that was approximately 2-3 times the patient’s sensory threshold. The continuous ultrasound (1MHz continuous at 1.2 W/cm2 for 5 min) using Metron Accusonic Plus .	38	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
ranging in age from 26 to 45 years, with chronic, non-specific low back pain for 3 months or more, their functional disability score assessed by Oswestry disability questionnaire, it must be equal or less than 40%, indicating a mild and moderate degrees of disability	1) continuous pain >8 on a visual analogue scale (VAS), 2) having nerve root symptoms, 3) having systemic disease and specific conditions such as neoplasm, fractures, spondylolysthesis, spondylolysis, spinal stenosis, ankylosing spondylitis, previous low back surgery, 4) previous attendance at any structured pelvic floor muscle training program, 5) previous spinal or pelvic surgery, 6) pregnancy or unwillingness to do exercise and 7) taking medication for specific psychological problems.	Adult: 19 Year-44 Year	26 Year(s)	45 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

06/05/2018

Research ethical committe of faculty of physical therapy Cairo university

Ethics Committee Address
Street address	City	Postal code	Country
7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Faculty of Physical Therapy, Cairo University	Giza	12611	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	static muscle endurance has been assessed by length of time the patient was able to maintain an unsupported upper body in the prone [extension] and supine positions (flexion)	Before and after 6 weeks of intervention
Primary Outcome	Dynamic muscle endurance has been assessed by the number of sit-ups (flexions) and prone trunk extensions performed in 1 min	before and after 6 weeks of intervention
Secondary Outcome	pain intensity	Before and after 6 weeks of intervention
Secondary Outcome	Spinal disability	Before and after 6 weeks of intervention

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
The patients were recruited from the physical therapy clinic of faculty of physical therapy	7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Faculty of Physical Therapy	Giza	12611	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
The authors were the source of funding	7 Ahmed Elziat Street, Ben Elsaryat, El Dokki, Faculty of Physical Therapy	Giza	12611	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	Faculty of physical therapy cairo university	7 Ahmed Elziat Street, Ben Elsaryat, Eldokki	giza	12611	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Public Enquiries	Amr Abdelaziem	amralmaz74@gmail.com	00201006229996	7 Ahmed Elziat Street, Ben Elsaryat, Eldokki, Faculty of Physical Therapy
City	Postal code	Country	Position/Affiliation
Giza	12611	Egypt	Professor of Biomechanics Faculty of Physical Therapy Cairo University
Role	Name	Email	Phone	Street address
Principal Investigator	Amr Abdelaziem	amralmaz74@gmail.com	00201006229996	Faculty of Physical Therapy, Cairo University, 7 Ahmed Elziat Street, Ben Elsaryat, Eldokki, Giza, Egypt
City	Postal code	Country	Position/Affiliation
Giza	12611	Egypt	Professor of Biomechanics Department of Biomechanics Faculty of Physical Therapy Cairo University
Role	Name	Email	Phone	Street address
Scientific Enquiries	Osama Abdelraouf	osamaibrahim2006@yahoo.com	00966567112454	7 Ahmed Elziat Street, Ben Elsaryat, Eldokki, Faculty of Physical therapy
City	Postal code	Country	Position/Affiliation
Giza	12611	Egypt	Assistant professor of Biomechanics

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	The patients' age ranged from 26 to 45 years, with chronic, non-specific LBP for 3 months or more, their functional disability score assessed by Oswestry disability questionnaire, it must be equal or less than 40%, indicating a mild and moderate degrees of disability.	Study Protocol	2 years	the journal that will publish the article will have the decision to share the participants data
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

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