To determine the effect of sciatic nerve mobilization in the management of patients with lumbar radicular pain.
Design
Single blind, Single Centre, parallel assignment Randomized Controlled Trial.
Settings and conduct
The study was conducted at out Patient Physiotherapy Department of Syeda Khatoon-e-Jannat Trust Hospital Faisalabad. only outcome assessor was blind in this study.
Participants/Inclusion and exclusion criteria
Patients with Age 25 -55 years from both genders with Positive Laseague sign or straight leg raise test, Unilateral leg pain radiation and more than 2 month's history were included, while patients with Infection –Tuberculosis, Inflammation around the lumbar spine, Tumors around the back, Lumbar instability/ Subluxation/ Fracture/ Spondylolisthesis, Osteoporosis, Joint hyper mobility, any red flag signs and Inability to comply with the study protocol due to cognitive impairment were excluded from study.
Intervention groups
Those patient who met eligibility criteria, were randomly allocated into two groups by using lottery method: Group A and Group B.
Group A: Experimental Group consisting of 40 patients. They performed 2 sets of 10 repetitions of each exercise 3 times/week for 2 weeks. Sciatic nerve mobilization was applied in appropriate position as per standard procedure.
Group B: Control Group contained 40 patients and was administered conventional physiotherapy treatment only.
Main outcome variables
Pain measured by numeric pain rating scale (NPRS), Modified Oswestry Disability Index and ROM by Inclinometer.
General information
Reason for update
Acronym
Sciatic Nerve Mobilization Trial
IRCT registration information
IRCT registration number:IRCT20201031049207N5
Registration date:2020-12-25, 1399/10/05
Registration timing:retrospective
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Wajida Perveen
Name of organization / entity
Sialkot college of Physical Therapy, Amin Welfare &Teaching Hospital, defence Road, Sialkot Pakistan
Country
Pakistan
Phone
+92 52 3250520
Email address
drwajidaperveenpt@scptamc.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-02, 1395/12/12
Expected recruitment end date
2017-10-30, 1396/08/08
Actual recruitment start date
2017-03-02, 1395/12/12
Actual recruitment end date
2017-10-30, 1396/08/08
Trial completion date
2017-11-20, 1396/08/29
Scientific title
Effects of Sciatic Nerve Mobilization versus Conventional physiotherapy Treatment in Patients with Lumbar Radicular Pain” A Randomized Control Trial
Public title
Sciatic Nerve Mobilization in Lumbar Radicular Pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 25 -55 years
Both genders
Positive Lasegue Sign
Pain radiation to Unilateral limb.
Pain Since more than 2 months.
Exclusion criteria:
Age less than 22 or more than 55 years.
Presence of any Red Flag signs.
Infection –Tuberculosis.
Lumbar Instability/ subluxation/ Fracture/ spondylolisthesis
Joint Hyper mobility.
Inability to comply with the study protocol due to cognitive impairment
Osteoporosis.
Tumors around the back
Inflammation around the lumbar spine.
Age
From 22 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients who met eligibility criteria's and signed the informed consent document were enrolled in the study. They were divided into two groups by using lottery method. Chits were prepared equal to total sample size, odd Numbers were allocated to Group A and even number were allocated to Group B. Each patient was requested to draw a chit from the box and after that patients were recruited into either Group A or Group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data safety was ensured by assigning Specific Identity numbers and all consent forms, data collection charts were placed in locker to blind Assessors
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
SCPT-IRB
Street address
Umer Street
City
Sialkot
Postal code
51310
Approval date
2017-02-10, 1395/11/22
Ethics committee reference number
SCPT-IRB-DPT-032-2017
Health conditions studied
1
Description of health condition studied
Normal Healthy Individuals with Lumber radicular Pain. The compression of any of the lumber nerve route can results in severe radicular pain. The onset of pain may begin suddenly or gradually after injury. The pain pattern is usually radicular with a sharp, shooting pain running down the lower back, buttocks and down the thigh along with numbness or tingling sensations. The pain is aggravated by prolonged sitting, standing, forward bending or twisting movements and is relieved by walking, lying down, rest and a recumbent position.
ICD-10 code
Radiculopa
ICD-10 code description
M54.16
Primary outcomes
1
Description
Pain
Timepoint
Before 1st session and after last session.
Method of measurement
pain will be measured using numeric pain rating scale subjectively.
2
Description
Functional disability
Timepoint
Before 1st session and after last session.
Method of measurement
Measured subjectively using Modified Oswestry Disability Index.
3
Description
Range of Motion-Straight Leg Raise (SLR)
Timepoint
Before 1st session and after last session.
Method of measurement
measured using Standard Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group-A In the beginning patients were given conventional baseline treatment according to North American spine society clinical guidelines and Sciatic nerve mobilization was added as an intervention. Sciatic nerve mobilization techniques were given in the form of 3 sets of 10 oscillatory movements at the ankle that were rhythmic ankle dorsiflexion and plantarflexion with a gap of 10 seconds between each set for 3 times a week for 2 weeks on alternate days.
Category
Treatment - Other
2
Description
Group B: Control group. Patients were given only conventional baseline treatment according to North American spine society clinical guidelines. It included moist hot pack for 15 minutes in prone lying position, and supervised back strengthening exercises consisting of pelvic tilts, bridging, quadruped alternate arm and leg activities, abdominal bracing exercises. Patients were asked to perform 2 sets of 10 repetitions of each exercise 3 times a week for 2 weeks on alternate days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Syeda Khatoon-E-Jannat Trust Hospital
Full name of responsible person
Kaneez Fatima
Street address
Satiana Road
City
Faisalabad
Postal code
38000
Phone
+92 41 8777616
Email
skjth7274@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Sargodha, Lyallpur Campus Faisalabad
Full name of responsible person
Zainab
Street address
Satiana Road
City
Faisalabad
Postal code
38000
Phone
+92 41 8792050
Email
info@uoslypfsd.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Physiotherpay Department, Independent Medical College.
Full name of responsible person
Sahreen Anwar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jinnah Colony
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2618283
Email
sahreenanwar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Sargodha Layallpur Campus
Full name of responsible person
ZAinab
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Satiana Road
City
Fisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8792050
Email
zainab.48@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sialkot College of Physical Therapy, Amin Welfare & Teaching Hospital.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Effects of Sciatic Nerve Mobilization versus Conventional physiotherapy Treatment in Patients with Lumbar Radicular Pain” A Randomized Control Trial. Consent form, Clinical Study Report, Statistical Plan files can be shared.
When the data will become available and for how long
after Publication for one year
To whom data/document is available
People working in academic institutions or people working in businesses can also contact Principal Investigator to receive it.
Under which criteria data/document could be used
the data can be included in meta analysis and systematic reviews. Person responsible for scientific inquiry will cater the other requests personally, review them on predefined criteria and respond accordingly.
From where data/document is obtainable
zainab.48@hotmail.com
What processes are involved for a request to access data/document
by formal email request Full description about the purpose/aim of using the documents, Insight about the disorder and Intervention of the research can be obtained.