Trial no.:	PACTR201909903222498	Date of Approval:	03/09/2019
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Efficacy of sidelying traction versus supine lying traction in treatment of lumbar disc herniation

Official scientific title

efficacy of sidelying traction versus supine lying traction in treatment of lumbar disc herniation

Brief summary describing the background and objectives of the trial

Lumbar disc herniation is the frequent cause of the low back pain. Low back pain (LBP) is defined as pain localized between the 12th rib and the inferior gluteal folds, with or without leg pain.Nonsurgical therapeutic options include pharmacologic agents and physical therapy.Lumbar traction is a commonly used method to treat patients with low back pain (LBP) with or without sciatica. In the UK and the US, 41% and 77% of outpatient rehabilitation providers respectively.There is contradiction in the literature about the efficacy of the traction and the guidelines for using it which make a necessary for further researching. Side lying position has various advantages. It is from the positions are recommended for decreasing the low back pain and sciatica pain. It is unloading position for lumbar vertebrae. [18] It makes relaxation of abdominal muscles and decreasing intra-abdominal pressure. It decreases intra discal pressure. It is using the advantage of gravity in reducing disc herniation. Adding rotation to the upper shoulder, it is widening the unilateral intervertebral foramen, which releases the disc pressure from the nerve root. Gapping the zygapophyseal joint Stimulation of such Z joint mechanoreceptors has been hypothesized as a mechanism of reducing pain via a gating mechanism in the spinal cord. [22] The study will compare the effects of both methods and will demonstrate which method will be more effective in the treatment of lumbar disc herniation with unilateral sciatica.This study will investigate the efficacy of lumbar traction as a part of physical therapy program. Investigate the effect of Side lying traction and Supine lying traction beside the standard physical therapy program and will demonstrate which one of both positions of tractions more effective in treatment of lumbar disc herniation with unilateral sciatica.

Type of trial

CCT

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

Treatment: Devices

Anticipated trial start date

01/06/2020

Actual trial start date

06/07/2019

Anticipated date of last follow up

30/04/2021

Actual Last follow-up date

01/05/2020

Anticipated target sample size (number of participants)

47

Actual target sample size (number of participants)

42

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	Simple randomization using by using procedures such as coin-tossing or dice-rolling	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	sidelying lumbar traction	40 - 50% from participant weight	10 weeks	the participant will be in sidelying position with benting his knees to his abdomen. motorized lumbar traction applied 40 - 50% from partisipant weight for twenty min with intermitten mode.	14
Experimental Group	supinelying lumbar traction	40 -50% from participant weight for 20 min with intermitten mode	10 weeks	the participant wil be in crocklying position with hip flex 70 degree.motorized lumbar traction applied beside exercises and advices	14
Control Group	exercises and advices	three times per day 15 sets per time	10 weeks	-single -double knee to chest exercises. -pelvic tilt exercise. -bridging exercise. -prone trunk extension exercises. -prone leg lift extension exercises.	14	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
-The patients age 30-50 years old. - The patient will be referred by orthopedist or neurologist as lumbar disc herniation with unilateral sciatica. - The diagnosis confirmed by lumbar CT scan or MRI. - The diagnosis confirmed by H reflex - The patient will be in subacute stage or chronic stage. - Body Mass Index BMI: 22-32Kg/M2.	- Lumbar disc herniation without sciatica. - Lumbar spondylisthesis - Lumbar instability Osteoporosis - Previous lumbar surgery - Scoliotic deformity or any deformity of lower extremity that may interfere with global alignment - Cancer - Cardiac problems - Peripheral neuropathy - History of upper motor neuron lesion - Spinal canal stenosis, other than disc herniation - Rheumatoid arthritis - Inability to tolerate Supine or side lying position	Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s)	30 Year(s)	50 Year(s)	Both

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

03/02/2019

faculty of physical therapy

Ethics Committee Address
Street address	City	Postal code	Country
Ahmed El Zayat street in front of ben el sarayat traffic-Dokki-Giza	Cairo	11432	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	h reflex	before and after termination of treatment
Primary Outcome	spinal CT scan	before and after treatment termination
Primary Outcome	OSWESTRY disability index	before and after treatment termination
Secondary Outcome	numerical pain rating scale	before and after treatment

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
ali ebn abe taleb clinic.	El baher street beside medical complex hospital.	Tanta	31511	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
peter ramzy	8 th abdullah ebn masood	tanta		Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	el menshawe hospital	el bahr street	Tanta	31511	Egypt	Hospital

COLLABORATORS
Name	Street address	City	Postal code	Country
Tarek El gamaal	el nahas street	tanta		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	peter ramzy	drpeter_07@yahoo.com	0201008211769	8th abdullah ebn masood
City	Postal code	Country	Position/Affiliation
Tanta	31511	Egypt	physical therapist
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohsen elsayyad	dr_sayyad1@hotmail.com	01142663054	el mohandeseen-Dokki-Giza
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	professor of physical therapy
Role	Name	Email	Phone	Street address
Public Enquiries	Ahmed elerian	ahmed_elerian_@cu.edu.eg	01116752333	elmaadi
City	Postal code	Country	Position/Affiliation
Cairo		Egypt	professor of physical therapy

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	age -sex-oswestry index score before and after treatment-h reflex results before and after treatment	Study Protocol	6 months	sidelying lumbar traction
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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