Protocol summary

Study aim
The aim of this study was to evaluate the effect of sciatic nerve mobilization technique and compare it with placebo treatment of sciatic nerve mobilization on pain indices, functional disability, sciatic nerve morphology and morphology of lumbar multifidus, biceps femoris, soleus and medial gastrocnemius muscles in patients with radiculopathy caused by disc bulging in lower back region.
Design
This study is a double-blind randomized controlled clinical trial with 46 participants.
Settings and conduct
Mobilization of sciatic nerve (nerve gliding technique) and placebo therapy on patients referred to the Faculty of Rehabilitation of Iran University. Participants and assessors are unaware of the group of people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- 46 patients with radiculopathy in one leg for at least 3 months (having at least one of the symptoms: pain, numbness, tingling). 2- Age between 18-55 3-A positive SLR test at an angle of 20 to 70 degrees. 4- Body mass index less than 30 5- Pain level based on NPRS in the lower back during the last 24 hours at rest between 40 and 60 6- Confirmation of disc bulging using MRI at levels of L4-L5 and L5-S1. 7- Minimum reading and writing literacy in cycles. Exclusion criteria: 1- Absence of any underlying disease, including diabetes, previous problems, etc. 2- Any dissatisfaction and lack of participation of patients. 3- Low back pain due to rheumatoid arthritis, inflammation of the spine joints, infection, vertebral fracture, trauma, osteoporosis, etc. 4- Pregnancy 5- Physical therapy at least 1 month ago
Intervention groups
Intervention group: receiving basic treatment with sciatic nerve mobilization Control group: Receiving basic treatment with placebo treatment of sciatic nerve mobilization
Main outcome variables
Pain, functional disability, SLR angle, morphology of sciatic nerve and nerve-giving muscles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190315043058N3
Registration date: 2024-03-29, 1403/01/10
Registration timing: prospective

Last update: 2024-03-29, 1403/01/10
Update count: 0
Registration date
2024-03-29, 1403/01/10
Registrant information
Name
Ismail Ebrahimi Takamjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2239 2426
Email address
ebrahimitakamjani.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-12-20, 1403/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sciatic nerve mobilization on pain, functional disability, sciatic nerve morphology and lower extremity muscles morphology in patients with lumbar radiculopathy due to disc herniation: A randomized controlled trial.
Public title
The effect of sciatic nerve mobilization on pain, functional disability, sciatic nerve morphology and lower extremity muscles morphology in patients with lumbar radiculopathy due to disc herniation: A randomized controlled trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
46 patients with radiculopathy in one leg for at least 3 months (having at least one of the symptoms: pain, numbness, tingling) Age between 18-55 Positive SLR test at an angle of 20 to 70 degrees Pain score based on the NPRS scale in the lower back should be more than 40 and less than 60 during the last 24 hours at rest. BMI<30 Confirmation of disc bluging using MRI at levels of L4-L5 and L5-S1. Having a minimum reading and writing literacy (cycle) to fill out questionnaires.
Exclusion criteria:
Absence of any underlying disease, including diabetes, previous problems, etc. Any dissatisfaction and lack of participation of patients during the course of treatment. Low back pain due to rheumatoid arthritis, inflammation of the spine joints, infection, spondylolisthesis, fracture, trauma, osteoporosis, etc. pregnancy Physical therapy at least 1 month ago Any disease during the course of treatment that interferes with the research process. Injury to the limbs or back area during the course of treatment. Absence of more than 2 sessions during the course of treatment.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
After completion of personal information and initial evaluations, patients with low back pain with radiculopathy symptoms will be randomly divided into two groups A or main treatment group: group B and control group receiving nerve mobilization placebo technique. Random allocation will be done in the variable block method, which consists of four-letter blocks made up of letters A and B. Then, the random list of treatments that will be obtained at the end of the assignment will be placed in the letters A and B in sealed and numbered envelopes (letter A represents nerve mobilization technique and the letter B represents the placebo technique of nerve mobilization). The random assignment process will be performed by an outside of the research team before the start of the study. After the initial evaluation by the examiner, the numbered envelopes will be presented to each person entering the study. Finally, after the patient enters the therapy sessions, the therapist will adjust the treatment interventions based on the letters in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be given envelopes in a closed envelope before the start of the first treatment session, and one of the letters A or B is written. Attendees deliver envelopes to their therapist, only the therapist is allowed to open the envelopes. The evaluator does not know the groups of participants.
Placebo
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 Highway., next to Milad Tower Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1341853347
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.IUMS.REC.1402.1167

Health conditions studied

1

Description of health condition studied
patients with lumbar radiculopathy due to disc herniation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period.
Method of measurement
Numeric pain rating scale (Moderate back pain in the last 24 hours at rest)

2

Description
Functional disability
Timepoint
Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period.
Method of measurement
Persian version of Oswestery disability index

3

Description
Straight leg raise Angle
Timepoint
Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period.
Method of measurement
Goniometer

Secondary outcomes

1

Description
Changes in Sciatic Nerve Morphology
Timepoint
At the beginning of the study (before the intervention) and immediately after the last treatment session
Method of measurement
Ultrasonography devices

2

Description
Morphological Changes in Lower Extremity Muscles
Timepoint
At the beginning of the study (before the intervention) and immediately after the last treatment session
Method of measurement
Ultrasonography devices

Intervention groups

1

Description
Intervention group: Mobilization of the sciatica nerve (gliding)
Category
Treatment - Other

2

Description
Intervention group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range).
Category
Treatment - Other

3

Description
Control group: Shame sciatic nerve mobilization techniques (nerve gliding)
Category
Placebo

4

Description
Control group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic of Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2222 2167
Email
maryamahmadima226@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Reza Falak
Street address
Hemmat Highway., Next to Milad Tower., Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86710
Email
info@iums.ac.ir
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
Dr. Esmaeel Ebrahimi Takamjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
ebrahimitakamjani.e@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Ahmadi
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
maryamahmadima226@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Esmaeel Ebrahimi Takamjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahnazari Ave., Mirdamad Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1998135353
Phone
+98 21 2239 2426
Email
maryamahmadima226@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
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