Trial no.:	PACTR201909860143787	Date of Approval:	25/09/2019
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Efficacy of Core Stability Exercise versus Traditional Physical Therapy on Spinopelvic Parameters, Pain level and Functional Disability in Patients with Lumbar Disc Degeneration

Official scientific title

Effect of core stabilization on spinopelvic parameters in lumbar disc degeneration

Brief summary describing the background and objectives of the trial

Degenerative disc disease (DDD) is fairly common and it is estimated that at least 30% of people aged 30-50 years old will have some degree of disc space degeneration, although not all will have pain or ever receive a formal diagnosis. The pain is frequently caused by simple wear and tear as part of the general ageing process. It can also be as a result of a twisting injury to the lower back. Chronic back pain is associated with the weakening of the lumbar extensor and flexor muscles, muscle imbalances, and especially lumbar instability. The variation of inclination in lumbar lordosis and scoliosis is one of the common causes of low back pain (LBP) due to abnormal posture and is a major contributor to the development of general low back pain.LBP patients have shown weakness in trunk muscle strength compared to those without LBP, and LBP is closely associated with subjects who lack lumbar stabilization due to reduced trunk muscle strength.Richardson et al. Suggested that transvers abdominis and the lumbar multifidus are primary stabilizers of the lumbar segment, minimizing compressive forces on the spinal structure.Therefore, strengthening lumbar muscles and increasing lumbar flexibility are important objectives of lumber pain treatment. Exercise can help strengthen muscles and maintain asymptomatic lumbar lordosis. Specifically, lumbar stabilization exercises can provide therapeutic benefits in the treatment of chronic back pain through the adjustment of vertebral segments and an increase in dynamic stability and lumbar muscle strength.

Type of trial

RCT

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

XRAY VAS Oswestry Disability Index

Disease(s) or condition(s) being studied

Musculoskeletal Diseases

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

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/06/2019

Actual trial start date

22/06/2019

Anticipated date of last follow up

01/01/2020

Actual Last follow-up date

01/01/2020

Anticipated target sample size (number of participants)

40

Actual target sample size (number of participants)

40

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
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	Care giver/Provider,Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	core stability exercise	three times per week	one month	Core stability exercises+hot backs+ultrasonic+TENS+strentheneg exercise for lumbar muscales	20
Control Group	Traditional physical therapy for lumbar disc degeneration	three times per week	one month	hot backs+ultrasonic+TENS+strentheneg exercise for lumbar muscales	20	Active-Treatment of Control Group

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
1. Patients with chronic LDD and low back dysfunction from more than three months. 2. Participants’ ages will be ranged from 30 to 50 years. 3. Lumbar instability indicating stabilization exercise. 4. Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%). 5. The patients will be screened before inclusion in the study by measuring their lumbopelvic radiographs for spinopelvic parametersmeasurements.	1. Contracture or surgery affecting lumbar spine. 2. Current medical treatment or physical therapy for LBP. 3. Pathologies such as skin diseases, inflammatory diseases, neurological diseases, congenital diseases, fractures, dislocations, neoplasms, and infection. 4. Visual or auditory problems. 5. Cognitive dysfunction. 6. Flat feet subjects. 7. Neurological dysfunction.	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

09/09/2018

faculty of physical therapy

Ethics Committee Address
Street address	City	Postal code	Country
ahmed el zaiat st	giza	99999	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	low back pain and spinopelvic parameters	pre and post measurement
Secondary Outcome	lumbar function	pre and post measurement

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
kasr alainy hospital cairo university	garden city	cairo	99999	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
ahmed sayed aly	Abo elseed street	qalubeya	3001	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	ahmed sayed ali sayed	khanka qalubya	qalubya	3001	Egypt	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country
Ahmed sayed ali sayed physical therapist at cairo university hospitals	sendewa	khanqa qalupya	11311	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	nevein abdelatif	dr_neveen_69@yahoo.com	+201064615553	nasr city
City	Postal code	Country	Position/Affiliation
cairo	99999	Egypt	vice dean of physical therapy faculty
Role	Name	Email	Phone	Street address
Scientific Enquiries	marwa shafiek	marwa_shafiek2000@yahoo.com	+201008342466	6 october bolaa
City	Postal code	Country	Position/Affiliation
giza	99999	Egypt	lecturer of physical therapy basic science department physical therapy faculty cairo university
Role	Name	Email	Phone	Street address
Public Enquiries	hatem mohamed al azizy	hatem_alazizy20@yahoo.com	+201001220617	nasr city
City	Postal code	Country	Position/Affiliation
cairo	99999	Egypt	professor of radiology cairo university medical school

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	there will be patient data sheet and informed consent form before beginning of the study also, there will be statistical analysis plan by data collection during study	Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol	during the study participation	all samples will participate and complete the study
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx	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

Pan African Clinical Trials Registry