Effect of Active Versus Passive Lower Extremity Neural Mobilization in Lumber Radiculopathy
Primary Purpose
Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Active neural mobilization
passive neural mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Active Neural Mobilization, Lumber Traction, Lumber Mobilization, Passive Neural Mobilization, Lumber Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- Pain radiate from lower lumber area to posterior aspect of leg up to planter surface of toes.
- Patient with confirmed L4-L5, L5-S1 disc herniation or disc bulge diagnosed by neurophysician.
- Numeric pain rating scale value is more than 4.
- Patients having positive compression distraction, Lasegue's sign and lower limb neural tension tests. (LLNTT).Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is <45°.
Exclusion Criteria:
- Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting
- blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
- Any systemic disease as diabetes or neurological condition that altered the function of the nervous system
- Prolong use of steroids.
- History of any surgery, trauma, or pathology of back, hip, knee, and ankle.
- Spinal stenosis, Potts disease
- Taking any treatment or medication except physiotherapy
Sites / Locations
- Shalamar hospital Lahore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active neural mobilization
passive neural mobilization
Arm Description
Therapist supervised active neural mobilization of sciatic nerve in lumber radiculopathy patients
Therapist done passicive neural mobilization of sciatic nerve in lumber radiculopathy patients
Outcomes
Primary Outcome Measures
Numeric Pain Rating Scale (NPRS)
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Secondary Outcome Measures
Straight Leg Raise (SLR)
A positive straight leg raising test (also known as Lasegue sign) results from gluteal or leg pain by passive straight leg flexion with the knee in extension, and it may correlate with nerve root irritation and possible entrapment with decreased nerve excursion
Oswestry Disability Index (ODI) questionnaire
The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Full Information
NCT ID
NCT04581239
First Posted
October 3, 2020
Last Updated
October 8, 2020
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04581239
Brief Title
Effect of Active Versus Passive Lower Extremity Neural Mobilization in Lumber Radiculopathy
Official Title
Effect of Active Versus Passive Lower Extremity Neural Mobilization Combined With Lumbar Traction and Lumbar Mobilization in Patients With Lumbar Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to find out the effects of active versus passive lower extremity neuralmobilizations combined with lumbar traction and lumbar mobilization in patients with lumbarradiculopathy. The study was conducted in shalamar hospital Lahore and was completed within 6 month of time duration. Sample size of twenty four patient consists of both male and female aged between 45 years to 65 years. Each group contain 12 patients. Group A received active neural mobilizations whereas group B received passive neural mobilization along with lumber traction and mobilization. Patients were re assessed at the end of 6 weeks through SLR , NPRS and ODI.
Detailed Description
Lower back pain is found to be one of the common health condition approximately 80% of individual experience back pain once in their lives. Radicular lower back pain is also a disorder that involves the dysfunction of the nerve roots of lumbosacral region. Its symptoms include radiating pain with numbness, paraesthesia and muscle weakness. In general population the annual prevalence of lumber radiculopathy varied from 9.9% to 25% .. Many of the spinal structures notably ligaments, paravertebral muscles, facet joints, spinal nerve roots and annulus fibrosis have been considered as the main cause of the pain. Clinical examinations mostly aim to clarify that whether a nerve root has mechanical impingement. The common clinical diagnostic tests include tests for tendon reflexes, straight leg raise test(SLR), sensory deficits and motor weakness. Several clinicians and researchers have come up with several debates for the treatment of Lower back pain. But not many studies have come up that actually authenticates that how much effective are physical therapy interventions. The common treatments for radical lower back pain includes physical modalities like TENS, ultrasound, Heat and Cryotherapy, lumbar traction and lumbar spinal mobilizations. Kinesiotherapy including ROM exercises and strengthening are also used to treat lower back pain. Neural mobilization techniques actually help in restoring the plasticity of nervous system. Plasticity of nervous system is actually the ability of the nerve surrounding structures to adapt of shift according to other structures. The aim of mobilization is actually to increase the collagen flexibility that helps in maintaining the integrity and movement of the nerve according to its surrounding structures. Radiculopathy management and lower back pain management have a direct link with neural mobilization.
However, evidence lacks whether active or passive lower extremity neural mobilization is more effective. Thus, the purpose of the current study is to compare the effects of active and passive neural mobilization in the management of lumbar radiculopathy, in combination with mechanical traction and joint mobilization.
In 2016 an RCT was conducted and concluded the efficacy of neural mobilization techniques in patients with radicular low back pain. They concluded that neural mobilizations techniques in radicular low back pain are effective. They stated that these techniques reduce the pain, functional disability and enhance the physiological functioning of the nerve root in patients in low back pain with lumbosacral radiculopathy . In 2014 A comparative study was conducted and found that lower extremity neural mobilizations along with conventional physiotherapy such as lumbar traction and lumbar mobilizations improves the agility in lower extremity and reduces pain and disability.
2013 a Study was conducted to observe observed the effects of neural mobilizations in the patients with radicular low back pain and concluded that patients treated with neural mobilizations showed better VAS score. They stated that further research is needed in order to assess the long-term effects of treatment and treatments provided on more than one occasion.
The purpose of the study was to determine the effects of active verses passive lower extremity neural mobilizations combined lumbar traction and lumbar mobilization so that in future this study should be helpful for other researchers to determine which therapy is most helpful in rehabilitation of the patients with radicular low back pain signs and symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Active Neural Mobilization, Lumber Traction, Lumber Mobilization, Passive Neural Mobilization, Lumber Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active neural mobilization
Arm Type
Active Comparator
Arm Description
Therapist supervised active neural mobilization of sciatic nerve in lumber radiculopathy patients
Arm Title
passive neural mobilization
Arm Type
Experimental
Arm Description
Therapist done passicive neural mobilization of sciatic nerve in lumber radiculopathy patients
Intervention Type
Other
Intervention Name(s)
Active neural mobilization
Intervention Description
Active neural mobilization Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization.
Active oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set
Intervention Type
Other
Intervention Name(s)
passive neural mobilization
Intervention Description
Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization
Passive neural mobilization This oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set. Both groups received total 18 session 3 session per week for consecutive 6 weeks
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Straight Leg Raise (SLR)
Description
A positive straight leg raising test (also known as Lasegue sign) results from gluteal or leg pain by passive straight leg flexion with the knee in extension, and it may correlate with nerve root irritation and possible entrapment with decreased nerve excursion
Time Frame
6 week
Title
Oswestry Disability Index (ODI) questionnaire
Description
The Oswestry Disability Index (ODI)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living.
Time Frame
6 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain radiate from lower lumber area to posterior aspect of leg up to planter surface of toes.
Patient with confirmed L4-L5, L5-S1 disc herniation or disc bulge diagnosed by neurophysician.
Numeric pain rating scale value is more than 4.
Patients having positive compression distraction, Lasegue's sign and lower limb neural tension tests. (LLNTT).Lasègue's sign is said to be positive if the angle to which the leg can be raised (upon straight leg raising) before eliciting pain is <45°.
Exclusion Criteria:
Any red flags (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, resting
blood pressure greater than 140/90 mmHg, prolonged history of steroid use, etc)
Any systemic disease as diabetes or neurological condition that altered the function of the nervous system
Prolong use of steroids.
History of any surgery, trauma, or pathology of back, hip, knee, and ankle.
Spinal stenosis, Potts disease
Taking any treatment or medication except physiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalamar hospital Lahore
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Active Versus Passive Lower Extremity Neural Mobilization in Lumber Radiculopathy
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