Nerve PainNCT01954199
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
A study testing Neurodynamic Group in people with Nerve Pain and Peripheral Nerve Injuries, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases
- What is being tested?
- Neurodynamic Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Apr 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral leg pain (Intensity ≥ 3)
- Pain distal to the buttocks
- Reproduction of symptoms and change in symptoms with structural differentiation (cervical return to neutral position or ankle dorsiflexion) with slump test;
Who cannot join
- cauda equina syndrome;
- bilateral leg pain;
- crossed Lasègue sign;
- previous surgery in the lumbar spine;
- inflammatory arthropathies;
- malignancy
- being in litigation or in work-compensation due to back and/or leg pain
- being receiving physiotherapy treatment at the time of baseline assessment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.
Read the detailed description
Nerve-related leg pain (NRLP) although less prevalent than low back pain itself, is associated with higher economic and social burden, and has been considered a predictor of chronicity and disability among subjects with low back pain.
Numerous approaches are proposed for its management; however, evidence regarding the best therapeutic approach is lacking. Neurodynamic techniques are proposed to be effective to manage NRLP.
Thus, this study aims to verify, through a randomized controlled trial, the effectiveness of a two-week program of neurodynamic techniques on pain and disability in individuals with NRLP.
- Conditions
- Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Sciatica, Low Back Pain, Low Back Ache
- Being tested
- Neurodynamic Group
- Keywords
- Sciatica, Nerve pain, Low back pain
- Medical subject headings
- Neuralgia, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Sciatica, Low Back Pain, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamic GroupProcedure or surgery
Also called Neural mobilization, Sliders, Tensioners, Nerve tissue management
All techniques will be executed in a pain-free way (grade III). Mild discomfort will be accepted, but it must subside as soon as the technique ends.
- In the dynamic opener technique, patient will be positioned in side-lying, with the affected side upwards. The therapist will then perform grade III oscillations aiming to open the lumbar foramen;
- In the side-lying slider, the patient will be in side-lying with the affected side upwards. A combination of knee and hip flexion and extension movements will produce sliding in the neural structures;
- In the slump slider, the patient will be seated in slump position. Combinations between neck and knee movements will produce greater nerve excursion than the side-lying slider. Patients will perform the slump slider in a pain-free manner.
| Study group | Role | What they receive |
|---|---|---|
| Neurodynamic group | Experimental | Patients allocated to this group will receive three different neurodynamic techniques: a lumbar foramen dynamic opener; a side-lying slider and a slider in the slump position. Patients will be asked to perform home exercises (a slider and a tensioner technique). Treatment will receive four treatments during two weeks (two sessions/week). Receives: Procedure: Neurodynamic Group |
| Control Group | No intervention | Patients allocated to Control Group (CG) will receive no intervention and will be advised according to the best evidence available; i.e, advice to remain active and to resume activities of daily living Upon trial completion, treatment will be offered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Pain Intensity
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Measured: Two weeks after randomization
Disability
Disability will be measured by the Oswestry Disability Index (ODI)
Measured: Two weeks after randomization
Secondary outcomes (7)
Leg pain Intensity
Leg Pain will me measured by a 0-10 Pain NRS
Measured: Four weeks after randomization
Disability
Disability will be measured by the Oswestry Disability Index (ODI)
Measured: Four weeks after randomization
Back pain intensity
Back Pain will me measured by an 0-10 Pain NRS
Measured: Two weeks after randomization
Back pain intensity
Back Pain will me measured by an 0-10 Pain NRS
Measured: Four weeks after randomization
Distribution of Symptoms
Distribution of symptoms will me measured by a body diagram
Measured: Two weeks, Four weeks after randomization
Function
Function will be measured by the Patient-Specific Functional Scale (PSFS)
Measured: Two weeks, Four weeks after randomization
Global Perceived Effect
Global Perceived Effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale
Measured: Two weeks, Four weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve PainStudies of the same condition, open and under way.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Esteves Ferreira, Federal University of Health Science of Porto Alegre
- Investigators
- Marcelo F Silva, PhD, Study chair, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954199
- Sponsor's protocol ID
- UFCSPA
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2013
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferreira G, Stieven F, Araujo F, Wiebusch M, Rosa C, Plentz R, Silva M. Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial. J Physiother. 2016 Oct;62(4):197-202. doi: 10.1016/j.jphys.2016.08.007. Epub 2016 Aug 24.
PubMed 27634158
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
- ClinicalTrials.gov ID
- NCT01954199
- Acronym / sponsor ID
- UFCSPA
- Conditions
- Nerve Pain, Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Sciatica, Low Back Pain, Low Back Ache
- Keywords
- Sciatica, Nerve pain, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 1 Oct 2013 (estimated)
- 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.
This study aims to verify if patients with nerve-related leg pain benefits from neurodynamic treatment over two weeks.
Detailed description
Nerve-related leg pain (NRLP) although less prevalent than low back pain itself, is associated with higher economic and social burden, and has been considered a predictor of chronicity and disability among subjects with low back pain.
Numerous approaches are proposed for its management; however, evidence regarding the best therapeutic approach is lacking. Neurodynamic techniques are proposed to be effective to manage NRLP.
Thus, this study aims to verify, through a randomized controlled trial, the effectiveness of a two-week program of neurodynamic techniques on pain and disability in individuals with NRLP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodynamic group | Experimental | Procedure: Neurodynamic GroupPatients allocated to this group will receive three different neurodynamic techniques: a lumbar foramen dynamic opener; a side-lying slider and a slider in the slump position. Patients will be asked to perform home exercises (a slider and a tensioner technique). Treatment will receive four treatments during two weeks (two sessions/week). |
| Control Group | No intervention | –Patients allocated to Control Group (CG) will receive no intervention and will be advised according to the best evidence available; i.e, advice to remain active and to resume activities of daily living Upon trial completion, treatment will be offered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral leg pain (Intensity ≥ 3)
- Pain distal to the buttocks
- Reproduction of symptoms and change in symptoms with structural differentiation (cervical return to neutral position or ankle dorsiflexion) with slump test;
Key exclusion criteria (8 listed)
- cauda equina syndrome;
- bilateral leg pain;
- crossed Lasègue sign;
- previous surgery in the lumbar spine;
- inflammatory arthropathies;
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 |
|---|---|---|
| Neurodynamic GroupAlso: Neural mobilization, Sliders, Tensioners, Nerve tissue managementAll techniques will be executed in a pain-free way (grade III). Mild discomfort will be accepted, but it must subside as soon as the technique ends. * In the dynamic opener technique, patient will be positioned in side-lying, with the affected side upwards. The therapist will then perform grade III oscillations aiming to open the lumbar foramen; * In the side-lying slider, the patient will be in side-lying with the affected side upwards. A combination of knee and hip flexion and extension movements will produce sliding in the neural structures; * In the slump slider, the patient will be seated in slump position. Combinations between neck and knee movements will produce greater nerve excursion than the side-lying slider. Patients will perform the slump slider in a pain-free manner. | Procedure or surgery | Neurodynamic group |
Primary outcome
Leg Pain Intensity
Time frame: Two weeks after randomization
Leg Pain will be measured by a 0-10 Numeric Rating Scale (Pain NRS)
Disability
Time frame: Two weeks after randomization
Disability will be measured by the Oswestry Disability Index (ODI)
7 secondary outcomes
Leg pain Intensity
Time frame: Four weeks after randomization
Disability
Time frame: Four weeks after randomization
Back pain intensity
Time frame: Two weeks after randomization
Back pain intensity
Time frame: Four weeks after randomization
Distribution of Symptoms
Time frame: Two weeks, Four weeks after randomization
Function
Time frame: Two weeks, Four weeks after randomization
Global Perceived Effect
Time frame: Two weeks, Four weeks after randomization
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 2 Jun 2016.
- Derived from this study: PubMed 27634158Ferreira G, Stieven F, Araujo F, Wiebusch M, Rosa C, Plentz R, Silva M. Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial. J Physiother. 2016 Oct;62(4):197-202. doi: 10.1016/j.jphys.2016.08.007. Epub 2016 Aug 24.
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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.
Marcelo F Silva, PhD study chair
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamic Group in people with Nerve Pain and Peripheral Nerve Injuries, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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 3 inclusion and 8 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 2 Jun 2016. 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 Brazil. 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?
Leg Pain Intensity (time frame: Two weeks after randomization). The study lists 2 primary outcomes in all. 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 NCT01954199, which also lists 1 linked publication.
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 2 Jun 2016.