Low Back PainNCT01145105
Neural Dynamics Technique for the Treatment of Chronic Radicular Low Back Pain
A study testing neural dynamics techniques treatment in people with Low Back Pain and Sciatica, run by Clalit Health Services at 1 site in Israel.
Trial summary
Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Sciatica
- What is being tested?
- neural dynamics techniques treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jul 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written consent
- LBP with radiation to one leg, that lasts more than 6 weeks
- Abnormal response to SLR test
- With or without neurological signs
Who cannot join
- History of spinal surgery
- Patient with FUO
- History of malignancies
- Patient with saddle anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg
Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.
It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.
Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.
Read the detailed description
Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;
- Conditions
- Low Back Pain, Sciatica
- Being tested
- neural dynamics techniques treatment, placebo treatment
- Keywords
- Low back pain, Sciatica, Pain, Physiotherapy
- Medical subject headings
- Low Back Pain, Sciatica, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neural dynamics techniques treatmentProcedure or surgery
Also called Physiotherapy
Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.
placebo treatmentProcedure or surgery
Also called physiotherapy
Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of neural dynamics technique
Efficacy will be measured by combining 5 tools
- Oswestry disability index.
- McGill Pain Questionnaire
- Visual analog scale for pain assessment.
- Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape.
- Passive SLR range of motion- measured with inclinometer
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uzi Milman, Clalit Health Services
- Investigators
- Noga Roguin Maor, MD, Principal investigator, clinical research unit, Clalit health services, Haifa and western Galilee district.Uzi Milman, MD, Study director, clinical research unit, Clalit health services, Haifa and western Galilee district.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145105
- Sponsor's protocol ID
- K-09-0078-ctil
- Status last verified
- Jul 2011
- First submitted
- 24 May 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neural Dynamics Technique in the Treatment of Chronic Low Back Pain With Radiation to the Leg
- ClinicalTrials.gov ID
- NCT01145105
- Acronym / sponsor ID
- K-09-0078-ctil
- Conditions
- Low Back Pain, Sciatica
- Keywords
- Low back pain, Sciatica, Pain, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Jun 2010 (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.
Low back pain ( LBP) is a significant health problem which affects about 70%-80% of the population during the course of their life . The majority of LBP is resolved within 3 months; however, up to 40% of LBP becomes chronic. One subgroup of chronic LBP is patients with sciatica. Sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain.
It has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. Patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg.
Working Hypothesis: Compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular LBP.
Detailed description
Objectives: To evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic Low back pain with radiation to the leg. Study Methodology: Eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. The treated individuals and the referring physician will also be blinded to the treatment allocation;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written consent
- LBP with radiation to one leg, that lasts more than 6 weeks
- Abnormal response to SLR test
- With or without neurological signs
Key exclusion criteria (4 listed)
- History of spinal surgery
- Patient with FUO
- History of malignancies
- Patient with saddle anesthesia
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 dynamics techniques treatmentAlso: PhysiotherapyTreatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve. | Procedure or surgery | – |
| placebo treatmentAlso: physiotherapyControl group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques. | Procedure or surgery | – |
Primary outcome
Efficacy of neural dynamics technique
Time frame: 5 weeks
Efficacy will be measured by combining 5 tools 1. Oswestry disability index. 2. McGill Pain Questionnaire 3. Visual analog scale for pain assessment. 4. Lumbar flexion measurement (the distance of the tip of the index finger to the inferior angle of the Patella, measured by a measurement tape. 5. Passive SLR range of motion- measured with inclinometer
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 10 Nov 2011.
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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.
Noga Roguin Maor, MD principal investigator
clinical research unit, Clalit health services, Haifa and western Galilee district.
Uzi Milman, MD study director
clinical research unit, Clalit health services, Haifa and western Galilee district.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neural dynamics techniques treatment in people with Low Back Pain and Sciatica, run by Clalit Health Services at 1 site in Israel.
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 4 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 10 Nov 2011. 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 Israel. 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?
Efficacy of neural dynamics technique (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2011.