Comparison of the effect of Neural Mobilization Techniques on Pain, Disability and Straight leg raising in Patients after Lumbar Discectomy between the experimental and control group
To explore the effectiveness of neurodynamic techniques on pain, straight leg raising (SLR) range, and disability in patients after lumbar discectomy
Design
A clinical trial was conducted involving a control group, with factorial groups, utilizing a double-blind, two-sided randomized design, on a total of 30 patients. Coin tossing was employed for randomization.
Settings and conduct
A total of 10 physiotherapy sessions with a one-day interval for both groups at Iran University of Medical Sciences in. Blinding was implemented for the participants, the evaluator of final results, and the statistical analysor.
Participants/Inclusion and exclusion criteria
All individuals residing in Tehran who have undergone lumbar discectomy surgery at the lower levels of the lumbar spine
Intervention groups
Both control and intervention groups undergo a 10-session treatment program with a 1-day interval between sessions, which includes the following components:
1. 20-minute high TENS.
2. 15-minute infrared therapy.
3. Instruction in stability exercises provided to all patients.
4. For the intervention group, in addition to the aforementioned exercises, neural mobilization techniques targeting the lower extremities and lumbar spine joints are applied by the researcher, considering these structures' relationship with nerves.
Main outcome variables
SLR, radicular pain, degree of disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230820059201N1
Registration date:2023-08-30, 1402/06/08
Registration timing:registered_while_recruiting
Last update:2023-08-30, 1402/06/08
Update count:0
Registration date
2023-08-30, 1402/06/08
Registrant information
Name
Hasti Heydarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2629 2512
Email address
hasti.heydarpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-29, 1402/06/07
Expected recruitment end date
2023-09-29, 1402/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Neural Mobilization Techniques on Pain, Disability and Straight leg raising in Patients after Lumbar Discectomy between the experimental and control group
Public title
Effect of Neural Mobilization Techniques in Patients after Lumbar Discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20-50
Body mass index less than 30
Having undergone lumbar discectomy no more than one week prior to enrollment
Positive Straight Leg Raise (SLR) test
Onset of symptoms prior to surgery within a maximum of one year
Severity of radicular pain ≥ 3 on the Visual Analog Scale (VAS).
Oswestry Disability Index (ODI) score ≥ 20%
Exclusion criteria:
patient's unwillingness to cooperate in the study
history of previous spinal surgery
history of mental disorders
systemic diseases (any cardiovascular, infectious, metabolic condition that could affect the assessment and treatment process)
stability disorders in the spine (spondylolysis, spondylolisthesis, etc.).No contractures or musculoskeletal disorders in the lower extremities that would hinder neurological mobilization tests and treatments
contractures or musculoskeletal disorders in the lower extremities that would hinder neurological mobilization tests and treatments
sacroiliac joint pain syndrome.
hip joint disorders
pregnancy
established hyperlordotic posture
nerve paralysis due to intervertebral disc protrusion.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Two test and control groups were designed for the study. The randomization was carried out using simple randomization and coin tossing. The control group was designated as "heads," and the test group as "tails." Based on the sample size, coin tossing was performed 28 times, and individuals were randomly assigned to two groups of 14 participants each.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those responsible for data collection and those assessing the outcome are kept blind to the intervention groups. This is done by assigning neutral codes to the participants (without giving information about patients' intervention grouping like S12).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Expressway, Next to Milad Tower, University of Medical Sciences of Iran, Central Headquarters Building, Research and Technology Deputy
City
Tehran
Province
Tehran
Postal code
1666692152
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.IUMS.REC.1397.1130
Health conditions studied
1
Description of health condition studied
The patients after lumbar discectomy surgery with radicular pain
ICD-10 code
M51.16
ICD-10 code description
Intervertebral disc disorders with radiculopathy, lumbar region
Primary outcomes
1
Description
Straight leg rasing rane of motion test
Timepoint
Before the intervention begins and after completing 10 intervention sessions
Method of measurement
digital inclinometer (2170-1 model)
2
Description
Radicular pain degree
Timepoint
Before the intervention begins and after completing 10 intervention sessions
Method of measurement
Visual analogue scale
3
Description
Patient's quality of life
Timepoint
Before the intervention begins and after completing 10 intervention sessions
Method of measurement
Oswestry disability index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine physiotherapy includes stability exercises and the use of TENS and infrared therapy, along with neurodynamic techniques performed by the researcher on the patient.
Category
Rehabilitation
2
Description
Control group: Routine physiotherapy includes stability exercises and the use of TENS and infrared therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Hasti Heydarpour
Street address
Mirdamad
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
rehab@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Research and Technology Deputy
Street address
Hemmat Expressway, Next to Milad Tower, University of Medical Sciences of Iran, Central Headquarters Building, Research and Technology Deputy
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Fax
Email
iums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Iran University of Medical Sciences
Full name of responsible person
Hasti Heydarpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
unit 15th, No. 21, Behyar Ave, Hedayat Ave, Darrus town
City
Tehran
Province
Tehran
Postal code
1666692152
Phone
+98 21 2256 0720
Email
hasti.heydarpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hasti Heydarpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Flat 15, No. 21, Behyar Ave, Hedayat St., Darrus County
City
Tehran
Province
Tehran
Postal code
1666692152
Phone
+98 21 2256 0720
Email
hasti.heydarpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hasti Heydarpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Flat 15, No. 21, Behyar Ave, Hedayat St., Darrus County
City
Tejran
Province
Tehran
Postal code
1666692152
Phone
+98 21 2256 0720
Email
hasti.heydarpour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data potentially shareable after making the individuals unidenfifiable
When the data will become available and for how long
access period begins immediately after publishing the results and lasts indefinitely.
To whom data/document is available
researchers employed at academic and scientific institutions
Under which criteria data/document could be used
Using the study results in similar research with proper citation is permissible. Contact method: Email