Lumbar RadiculopathyNCT04581239
Effect of Active Versus Passive Lower Extremity Neural Mobilization in Lumber Radiculopathy
A study testing Active neural mobilization and passive neural mobilization in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Active neural mobilization and passive neural mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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°.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Active Versus Passive Lower Extremity Neural Mobilization Combined With Lumbar Traction and Lumbar Mobilization in Patients With Lumbar Radiculopathy
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.
Read the 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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Active neural mobilization, passive neural mobilization
- Keywords
- Active Neural Mobilization, Lumber Traction, Lumber Mobilization, Passive Neural Mobilization, Lumber Radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active neural mobilizationOther
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
passive neural mobilizationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Active neural mobilization | Active comparator | Therapist supervised active neural mobilization of sciatic nerve in lumber radiculopathy patients Receives: Other: Active neural mobilization |
| passive neural mobilization | Experimental | Therapist done passicive neural mobilization of sciatic nerve in lumber radiculopathy patients Receives: Other: passive neural mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 week
Secondary outcomes (2)
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
Measured: 6 week
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start15 Mar 2019
- Primary completion20 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581239
- Sponsor's protocol ID
- REC/19/2025 Hafiz Abdul Rehman
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Masters S, Lind R. Musculoskeletal pain - presentations to general practice. Aust Fam Physician. 2010 Jun;39(6):425-8.
PubMed 20628683Satpute K, Hall T, Bisen R, Lokhande P. The Effect of Spinal Mobilization With Leg Movement in Patients With Lumbar Radiculopathy-A Double-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 May;100(5):828-836. doi: 10.1016/j.apmr.2018.11.004. Epub 2018 Dec 3.
PubMed 30521781Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.
PubMed 19119380Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc herniation with associated radiculopathy: a systematic review. Spine (Phila Pa 1976). 2010 May 15;35(11):E488-504. doi: 10.1097/BRS.0b013e3181cc3f56.
PubMed 20421859Harte AA, Baxter GD, Gracey JH. The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord. 2007 Nov 29;8:118. doi: 10.1186/1471-2474-8-118.
PubMed 18047650Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
PubMed 22851876Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.
PubMed 25892373Kawakami M, Weinstein JN, Spratt KF, Chatani K, Traub RJ, Meller ST, Gebhart GF. Experimental lumbar radiculopathy. Immunohistochemical and quantitative demonstrations of pain induced by lumbar nerve root irritation of the rat. Spine (Phila Pa 1976). 1994 Aug 15;19(16):1780-94. doi: 10.1097/00007632-199408150-00001.
PubMed 7526474Kostadinovic S, Milovanovic N, Jovanovic J, Tomasevic-Todorovic S. Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(6):897-907. doi: 10.3233/BMR-201843.
PubMed 32675390Winkelstein BA, DeLeo JA. Nerve root injury severity differentially modulates spinal glial activation in a rat lumbar radiculopathy model: considerations for persistent pain. Brain Res. 2002 Nov 29;956(2):294-301. doi: 10.1016/s0006-8993(02)03560-6.
PubMed 12445698Kobayashi S, Kokubo Y, Uchida K, Yayama T, Takeno K, Negoro K, Nakajima H, Baba H, Yoshizawa H. Effect of lumbar nerve root compression on primary sensory neurons and their central branches: changes in the nociceptive neuropeptides substance P and somatostatin. Spine (Phila Pa 1976). 2005 Feb 1;30(3):276-82. doi: 10.1097/01.brs.0000152377.72468.f4.
PubMed 15682006Leininger B, Bronfort G, Evans R, Reiter T. Spinal manipulation or mobilization for radiculopathy: a systematic review. Phys Med Rehabil Clin N Am. 2011 Feb;22(1):105-25. doi: 10.1016/j.pmr.2010.11.002. Epub 2010 Dec 30.
PubMed 21292148Plaza-Manzano G, Cancela-Cilleruelo I, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL, Thoomes-de-Graaf M, Ortega-Santiago R. Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial. Am J Phys Med Rehabil. 2020 Feb;99(2):124-132. doi: 10.1097/PHM.0000000000001295.
PubMed 31464753Han L, Zhao P, Guo W, Wei J, Wang F, Fan Y, Li Y, Min Y. Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:122. doi: 10.1186/s13063-015-0634-0.
PubMed 25872929
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Active Versus Passive Lower Extremity Neural Mobilization Combined With Lumbar Traction and Lumbar Mobilization in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT04581239
- Acronym / sponsor ID
- REC/19/2025 Hafiz Abdul Rehman
- Conditions
- Lumbar Radiculopathy
- Keywords
- Active Neural Mobilization, Lumber Traction, Lumber Mobilization, Passive Neural Mobilization, Lumber Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active neural mobilization | Active comparator | Other: Active neural mobilizationTherapist supervised active neural mobilization of sciatic nerve in lumber radiculopathy patients |
| passive neural mobilization | Experimental | Other: passive neural mobilizationTherapist done passicive neural mobilization of sciatic nerve in lumber radiculopathy patients |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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°.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active neural mobilizationActive 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 | Other | Active neural mobilization |
| passive neural mobilizationBase 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 | Other | passive neural mobilization |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 week
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.
2 secondary outcomes
Straight Leg Raise (SLR)
Time frame: 6 week
Oswestry Disability Index (ODI) questionnaire
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Background: PubMed 20628683Masters S, Lind R. Musculoskeletal pain - presentations to general practice. Aust Fam Physician. 2010 Jun;39(6):425-8.
- Background: PubMed 30521781Satpute K, Hall T, Bisen R, Lokhande P. The Effect of Spinal Mobilization With Leg Movement in Patients With Lumbar Radiculopathy-A Double-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 May;100(5):828-836. doi: 10.1016/j.apmr.2018.11.004. Epub 2018 Dec 3.
- Background: PubMed 19119380Ellis RF, Hing WA. Neural mobilization: a systematic review of randomized controlled trials with an analysis of therapeutic efficacy. J Man Manip Ther. 2008;16(1):8-22. doi: 10.1179/106698108790818594.
- Background: PubMed 20421859Hahne AJ, Ford JJ, McMeeken JM. Conservative management of lumbar disc herniation with associated radiculopathy: a systematic review. Spine (Phila Pa 1976). 2010 May 15;35(11):E488-504. doi: 10.1097/BRS.0b013e3181cc3f56.
- Background: PubMed 18047650Harte AA, Baxter GD, Gracey JH. The effectiveness of motorised lumbar traction in the management of LBP with lumbo sacral nerve root involvement: a feasibility study. BMC Musculoskelet Disord. 2007 Nov 29;8:118. doi: 10.1186/1471-2474-8-118.
- Background: PubMed 22851876Boyles R, Toy P, Mellon J Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011 Aug;19(3):135-42. doi: 10.1179/2042618611Y.0000000011.
- Background: PubMed 25892373Efstathiou MA, Stefanakis M, Savva C, Giakas G. Effectiveness of neural mobilization in patients with spinal radiculopathy: a critical review. J Bodyw Mov Ther. 2015 Apr;19(2):205-12. doi: 10.1016/j.jbmt.2014.08.006. Epub 2014 Aug 17.
- Background: PubMed 7526474Kawakami M, Weinstein JN, Spratt KF, Chatani K, Traub RJ, Meller ST, Gebhart GF. Experimental lumbar radiculopathy. Immunohistochemical and quantitative demonstrations of pain induced by lumbar nerve root irritation of the rat. Spine (Phila Pa 1976). 1994 Aug 15;19(16):1780-94. doi: 10.1097/00007632-199408150-00001.
- Background: PubMed 32675390Kostadinovic S, Milovanovic N, Jovanovic J, Tomasevic-Todorovic S. Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(6):897-907. doi: 10.3233/BMR-201843.
- Background: PubMed 12445698Winkelstein BA, DeLeo JA. Nerve root injury severity differentially modulates spinal glial activation in a rat lumbar radiculopathy model: considerations for persistent pain. Brain Res. 2002 Nov 29;956(2):294-301. doi: 10.1016/s0006-8993(02)03560-6.
- Background: PubMed 15682006Kobayashi S, Kokubo Y, Uchida K, Yayama T, Takeno K, Negoro K, Nakajima H, Baba H, Yoshizawa H. Effect of lumbar nerve root compression on primary sensory neurons and their central branches: changes in the nociceptive neuropeptides substance P and somatostatin. Spine (Phila Pa 1976). 2005 Feb 1;30(3):276-82. doi: 10.1097/01.brs.0000152377.72468.f4.
- Background: PubMed 21292148Leininger B, Bronfort G, Evans R, Reiter T. Spinal manipulation or mobilization for radiculopathy: a systematic review. Phys Med Rehabil Clin N Am. 2011 Feb;22(1):105-25. doi: 10.1016/j.pmr.2010.11.002. Epub 2010 Dec 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binash Afzal, Phd* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active neural mobilization and passive neural mobilization in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 6 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581239, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.