RadiculitisNCT02941133
Comparison of Neural Mobilization Techniques to Standard Care Treatment in Patients With Lumbar Radiculitis
A study testing Neural Mobilization in people with Radiculitis, run by Michalis Efstathiou.
Trial summary
The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiculitis
- What is being tested?
- Neural Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with low back pain and pain that radiates in the lower limb
- Duration of symptoms > 6 weeks
- Patients willing to be reassessed after 6 months
- Patients willing to give written informed consent
Who cannot join
- History of spinal surgery
- History of surgery or injury in the lower limbs in the past 6 months
- Signs and symptoms of central nervous system involvement
- Nerve root blocks for the past 6 weeks
- History of diabetes
- History of polyneuropathies
Show all 9Show fewer
- History of vascular pathologies in the lower limbs
- History of systemic pathologies
- History of inflammatory arthropathies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.
Read the detailed description
Background:
Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs.
It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques.
Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality.
The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis.
Participants:
Patients with low back pain that radiates to the lower limb.
Patients that satisfy the inclusion criteria will be screened and classified by another researcher into the distinct group of lumbar radiculitis. Another researcher will take baseline measurements and all patients of this sub-group will be randomly assigned to receive either neural mobilization or standard care physiotherapy treatment. Both groups will receive a total of 10 treatments twice per week for 5 weeks. Patients will be assessed using specific outcome measures prior to treatment (baseline), at 5 weeks (post treatment) and 6 months after treatment.
Statistical analysis:
Data will be analysed with the Statistical Package for the Social Sciences (SPSS), version 22. Intension to treat analysis will be applied. A two-way mixed-model analysis of variance will be used for outcome measures, with treatment groups (neural mobilization or standard care treatment) as the between-subject variable and time (baseline, 1 month follow up, six months follow up) as the within-subject variable. Comparison of baseline demographic characteristics will be analysed using the t-tests for continuous variables and the chi square tests for categorical variables.
- Conditions
- Radiculitis
- Being tested
- Neural Mobilization, Standard Care
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural MobilizationOther
Neural mobilization techniques aimed at the lumbar root that is affected
Standard CareOther
Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Neural Mobilization Group | Experimental | Patients in this group will be treated with neural mobilization techniques. Receives: Other: Neural Mobilization |
| Standard Care Group | Experimental | Patients in this group will be treated with standard care (ultrasound, exercise, TENS, massage) Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) - Measure assessing change
The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).
Measured: Change from baseline after 5 weeks and at 6 months
Secondary outcomes (3)
Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
The questioner measures the level of patients' disability.
Measured: Change from baseline after 5 weeks and at 6 months
Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
The questioner evaluates fear-avoidance beliefs of patients with low back pain in the clinical setting.
Measured: Change from baseline after 5 weeks and at 6 months
Handheld dynamometer - Measure assessing change
Changes in Muscle Strength assessed with the handheld dynamometer
Measured: Change from baseline after 5 weeks and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
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 RadiculitisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michalis Efstathiou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michalis Efstathiou, University of Nicosia
- Investigators
- Michalis Efstathiou, MSc, Principal investigator, University of Nicosia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941133
- Sponsor's protocol ID
- MISS13
- Status last verified
- May 2017
- First submitted
- 19 Oct 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.
PubMed 21116662
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02941133
- Acronym / sponsor ID
- MISS13
- Conditions
- Radiculitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Michalis EfstathiouUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 21 Oct 2016 (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.
The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.
Detailed description
Background:
Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs.
It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques.
Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality.
The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis.
Participants:
Patients with low back pain that radiates to the lower limb.
Patients that satisfy the inclusion criteria will be screened and classified by another researcher into the distinct group of lumbar radiculitis. Another researcher will take baseline measurements and all patients of this sub-group will be randomly assigned to receive either neural mobilization or standard care physiotherapy treatment. Both groups will receive a total of 10 treatments twice per week for 5 weeks. Patients will be assessed using specific outcome measures prior to treatment (baseline), at 5 weeks (post treatment) and 6 months after treatment.
Statistical analysis:
Data will be analysed with the Statistical Package for the Social Sciences (SPSS), version 22. Intension to treat analysis will be applied. A two-way mixed-model analysis of variance will be used for outcome measures, with treatment groups (neural mobilization or standard care treatment) as the between-subject variable and time (baseline, 1 month follow up, six months follow up) as the within-subject variable. Comparison of baseline demographic characteristics will be analysed using the t-tests for continuous variables and the chi square tests for categorical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Mobilization Group | Experimental | Other: Neural MobilizationPatients in this group will be treated with neural mobilization techniques. |
| Standard Care Group | Experimental | Other: Standard CarePatients in this group will be treated with standard care (ultrasound, exercise, TENS, massage) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with low back pain and pain that radiates in the lower limb
- Duration of symptoms > 6 weeks
- Patients willing to be reassessed after 6 months
- Patients willing to give written informed consent
Key exclusion criteria (9 listed)
- History of spinal surgery
- History of surgery or injury in the lower limbs in the past 6 months
- Signs and symptoms of central nervous system involvement
- Nerve root blocks for the past 6 weeks
- History of diabetes
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 |
|---|---|---|
| Neural MobilizationNeural mobilization techniques aimed at the lumbar root that is affected | Other | Neural Mobilization Group |
| Standard CareUltrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises | Other | Standard Care Group |
Primary outcome
Visual Analogue Scale (VAS) - Measure assessing change
Time frame: Change from baseline after 5 weeks and at 6 months
The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).
3 secondary outcomes
Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change
Time frame: Change from baseline after 5 weeks and at 6 months
Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change
Time frame: Change from baseline after 5 weeks and at 6 months
Handheld dynamometer - Measure assessing change
Time frame: Change from baseline after 5 weeks and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Results publication: PubMed 21116662Schafer A, Hall T, Muller G, Briffa K. Outcomes differ between subgroups of patients with low back and leg pain following neural manual therapy: a prospective cohort study. Eur Spine J. 2011 Mar;20(3):482-90. doi: 10.1007/s00586-010-1632-2. Epub 2010 Dec 1.
- Individual participant dataSharing planned: Undecided
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.
Michalis Efstathiou, MSc principal investigator
University of Nicosia
Questions about this trial
What is this clinical trial studying?
A study testing Neural Mobilization in people with Radiculitis, run by Michalis Efstathiou.
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 9 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: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michalis Efstathiou, MSc (+35799931840, efstathiou.m@unic.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) - Measure assessing change (time frame: Change from baseline after 5 weeks and at 6 months). 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 NCT02941133, 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 5 May 2017.