Protocol summary

Study aim
the aim of study is to check the effects of slump neural mobilization for the treatment of chronic radicular low back pain. the out come measures will be pain, range of motion and level of disability. Pain will be checked using numeric pain rating scale, lumbar flexion range of motion will be calculated using inches tape and disability will be calculated using oswestry disability low back pain questionnaire. the statistical analysis will be done using SPSS version 20.
Design
Randomized clinical trial will be done in which therapist will note the readings taken from both experimental and control group
Settings and conduct
Hospital Settings of Faisalabad including Allied hospital Faisalabad, National hospital Faisalabad, Govt. General Hospital faisalabad abd Aziz Fatima hospital Faisalabad, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Age 25 to 50 years • Gender both male and female • Numbness and tingling till big toe • Pain more than 6 months • 1 to 6 pain reading on NPRS • No surgery of lumbar region or sugery for more than 5 years • Positive slump test Exclusion Criteria • Patients with knee contractures • Pregnant women with 3rd trimester • Post surgical patients of lower leg • Amputation below knee • Spinal fracture • Spinal infection • Neoplasm • Osteoporosis • Signs of upper motor neuron involvement
Intervention groups
Group A: Slump neural mobilization, Proprioceptive neuromuscular facilitation rhythmic stabilisation technique and hot pack Group B: Proprioceptive neuromuscular facilitation rhythmic stabilisation technique and hot pack
Main outcome variables
Outcomes will be Pain, lumbar flexion range of motion and Disability calculated using numeric pain rating scale, inches tape and Oswestry disability low back pain questionnaire

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20230617058506N1
Registration date: 2023-07-19, 1402/04/28
Registration timing: prospective

Last update: 2023-07-19, 1402/04/28
Update count: 0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Dr Javeria Ashraf
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2692733
Email address
ajaveria231@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-24, 1402/05/02
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
2023-07-24, 1402/05/02
Actual recruitment end date
2023-09-30, 1402/07/08
Trial completion date
2023-10-01, 1402/07/09
Scientific title
Effect of slump neural mobilization for the treatment of chronic radicular low back pain
Public title
Effect of slump neural mobilization for the treatment of chronic radicular low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to 50 years Gender both male and female Numbness and tingling till big toe Pain more than 6 months 1 to 6 pain reading on NPRS No surgery of lumbar region or sugery for more than 5 years Positive slump test
Exclusion criteria:
Patients with knee contractures Pregnant women with 3rd trimester Post surgical patients of lower leg Amputation below knee Spinal fracture Spinal infection Neoplasm Osteoporosis Signs of upper motor neuron involvement
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation was done using lottery method. The randomization was done with the help of lottery method. Lottery generated numbers were drawn from the computer by the help of sample size. Different numbers were entered in the poll of group A which was the experimental group while the remaining number drawn from lottery methods were included in the control group named group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
single investigator investigate the out come measures. Single investigator screened the patients on the basis of inclusion and exclusion criteria. After that with the help of lottery generated number assign each patient wether in experimental group or control group. The treatment will be applied on each patient according to their group. After that the investigator take the reading to make the results accordingly
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committe of The University of Faisalabad named Dr Matloob Ahmad, Assoc Prof Dr Khawaja Adeel
Street address
12 GH, street 3 farid colony opp. Razaabad, Faislaabd
City
Faisalabad
Postal code
38000
Approval date
2023-03-21, 1402/01/01
Ethics committee reference number
TUF/DR/SA/MSPP/2023/239

Health conditions studied

1

Description of health condition studied
Low back pain is a common health issue now a days which should be treated in all the primary health care settings. pain is present above the inferior gluteal region and below lower costal margins. Low back pain can be radiating or non-radiating in nature which should be ruled out. The most common type of radiating low back pain is known as sciatica.
ICD-10 code
M54.50
ICD-10 code description
Low Back Pain

Primary outcomes

1

Description
Pain
Timepoint
Before starting intervention, 2nd reading will be taken at 2nd week and 3rd reading will be taken at 5th week post-intervention
Method of measurement
pain will be measured using numeric pain rating scale

Secondary outcomes

1

Description
Range of motion of lumbar flexion
Timepoint
first reading at baseline, 2nd reading at 2nd week and 3rd reading at 5th week post intervention
Method of measurement
range of motion will be calculated using inches tape

2

Description
Disability
Timepoint
Reading will be taken before staring the intervention i.e. baseline reading, 2nd reading post treatment will be taken after 2nd week and 3rd final reading post treatment will be taken after 5th week.
Method of measurement
Disability will be measured using Oswestry disability low back pain questionnaire

Intervention groups

1

Description
Group A: Experimental group: Received Slump neural mobilization. proprioceptive neuromuscular facilitation rhythmic stabilization technique and hot pack
Category
Rehabilitation

2

Description
Control group: Group B: Recieved PNF-RS and hot pack
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital faisalabad
Full name of responsible person
Dr. Arshad Ali
Street address
Jail road adjacent Faisalabad medical university Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Fax
+92 41 9210079
Email
vcfmuf@gmail.com
Web page address
https://pmc.edu.pk/S-Result.aspx

2

Recruitment center
Name of recruitment center
National Hospital Faisalabad
Full name of responsible person
Dr Zaeem Aslam
Street address
No. C3C7+75R, Gulberg Rd, Jinnah Colony, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 2611496
Fax
+92 41 2611146
Email
hr@nationalhospital.com
Web page address
https://contactinfo.pk/the-national-hospital-faisalabad-contact-number/

3

Recruitment center
Name of recruitment center
Govt. General Hospital Faisalabad
Full name of responsible person
Dr. Amir Naveed
Street address
No: C2VW+667, Block C Ghulam Muhammad Abad, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9330323
Fax
Email
gghgmabadfsd@gmail.com
Web page address
https://pmc.edu.pk/S-TimeTable1.aspx

4

Recruitment center
Name of recruitment center
Aziz Fatima Hospital, Faisalabad
Full name of responsible person
Dr Basit Mehmood
Street address
Raja Road, Lahore - Sheikhupura - Faisalabad Rd, Gulistan Colony Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8780910
Fax
+92 41 8862131
Email
manager.lab@afh.com.pk
Web page address
https://www.facebook.com/AzizFatimahHospital/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Anbreena Rasool
Street address
Sargodha Rd, University Town, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8750971
Fax
+92 41 8750970
Email
Info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Javeria Ashraf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
12 GH Street 3 Farid colony opp. Razaabad, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2692733
Fax
Email
ajaveria231@gmai.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Javeria Ashraf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
12 GH, street 3 Farid colony opp. Razaabad, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2692733
Email
ajaveria231@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Javeria Ashraf
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
12 GH Street 3 Farid colony opp. Razaabad, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2692733
Fax
Email
ajaveria231@gmai.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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