Sciatica PainNCT03663842
Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
A study testing Physical therapy treatment in people with Sciatica Pain and Physical Therapy Modalities, run by Centro Universitário Augusto Motta.
Trial summary
Objectives: To analyse the effects of sciatic neural mobilisation, in combination to the treatment of the surrounding structures, on pain and disability. Secondly, to investigate baseline characteristics that may be associated with improvements in pain and lumbar disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sciatica Pain, Physical Therapy Modalities, Manual Therapies
- What is being tested?
- Physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2010to 10 Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain with radiating leg pain and/or paresthesia below the knee that follows the L5 and/or S1 dermatomal pattern.
Who cannot join
- History of lumbar and abdominal surgery
- Rheumatologic syndromes (e.g. Rheumatoid arthritis);
- Lumbar stenosis.
About this study
Objectives: To analyse the effects of sciatic neural mobilisation, in combination to the treatment of the surrounding structures, on pain and disability. Secondly, to investigate baseline characteristics that may be associated with improvements in pain and lumbar disability. Methods: Twenty-eight patients with a clinical diagnosis of sciatica were treated with neural mobilization, joint mobilisation and soft tissue techniques. Pain intensity and lumbar disability were assessed at baseline and after treatment using a Numerical Rating Scale (0-10) and the Oswestry Disability Index (0-100), respectively. The pre- and post-intervention data were compared.
- Being tested
- Physical therapy treatment
- Keywords
- Lumbosacral Plexus, Physical Therapy Modalities, Manual Therapies, Disability Evaluation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy treatmentOther
All patients underwent the same techniques, and there was no modification of the intervention protocol during the study: (1) Myofascial release technique - piriformis muscle and biceps femoral muscle; (2) Hip joint mobilization; (3) Cross-fiber friction over the sacroiliac joints; (4) Neural mobilization to improve sciatic nerve excursion.
| Study group | Role | What they receive |
|---|---|---|
| Neural tissue management | Experimental | Myofascial release technique; Hip joint mobilization technique; Cross-fiber friction over the sacroiliac joints; Neural mobilization to improve sciatic nerve excursion. Receives: Other: Physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured by the Numerical Rating Scale (NRS 0-10)
Measured: From enrollment to end of treatment at 12 weeks
Lumbar disability
Assessed by the Oswestry Disability Index (ODI).It consists of 10 items addressing different aspects of disability. Each item is scored from 0 to 5, with higher values representing greater disability. The sum of the item scores is divided by the total possible score (50 if all sections are completed), and the resulting total is multiplied by 100 to be described as a percentage score.
Measured: From enrollment to end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start10 May 2010
- Primary completion10 Nov 2010
- Study completion10 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatica 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Almeida, Centro Universitário Augusto Motta
- Investigators
- Renato Almeida, PhD, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663842
- Sponsor's protocol ID
- 25/2010
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica
- ClinicalTrials.gov ID
- NCT03663842
- Acronym / sponsor ID
- 25/2010
- Keywords
- Lumbosacral Plexus, Physical Therapy Modalities, Manual Therapies, Disability Evaluation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- 10 May 2010 (actual)
- Primary completion
- 10 Nov 2010 (actual)
- Study completion
- 10 Dec 2010 (actual)
- First posted
- 10 Sep 2018 (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.
Objectives: To analyse the effects of sciatic neural mobilisation, in combination to the treatment of the surrounding structures, on pain and disability. Secondly, to investigate baseline characteristics that may be associated with improvements in pain and lumbar disability. Methods: Twenty-eight patients with a clinical diagnosis of sciatica were treated with neural mobilization, joint mobilisation and soft tissue techniques. Pain intensity and lumbar disability were assessed at baseline and after treatment using a Numerical Rating Scale (0-10) and the Oswestry Disability Index (0-100), respectively. The pre- and post-intervention data were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural tissue management | Experimental | Other: Physical therapy treatmentMyofascial release technique; Hip joint mobilization technique; Cross-fiber friction over the sacroiliac joints; Neural mobilization to improve sciatic nerve excursion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low back pain with radiating leg pain and/or paresthesia below the knee that follows the L5 and/or S1 dermatomal pattern.
Key exclusion criteria (3 listed)
- History of lumbar and abdominal surgery
- Rheumatologic syndromes (e.g. Rheumatoid arthritis);
- Lumbar stenosis.
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 |
|---|---|---|
| Physical therapy treatmentAll patients underwent the same techniques, and there was no modification of the intervention protocol during the study: (1) Myofascial release technique - piriformis muscle and biceps femoral muscle; (2) Hip joint mobilization; (3) Cross-fiber friction over the sacroiliac joints; (4) Neural mobilization to improve sciatic nerve excursion. | Other | Neural tissue management |
Primary outcome
Pain intensity
Time frame: From enrollment to end of treatment at 12 weeks
Measured by the Numerical Rating Scale (NRS 0-10)
Lumbar disability
Time frame: From enrollment to end of treatment at 12 weeks.
Assessed by the Oswestry Disability Index (ODI).It consists of 10 items addressing different aspects of disability. Each item is scored from 0 to 5, with higher values representing greater disability. The sum of the item scores is divided by the total possible score (50 if all sections are completed), and the resulting total is multiplied by 100 to be described as a percentage score.
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 Sep 2018.
- 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.
Renato Almeida, PhD principal investigator
Centro Universitário Augusto Motta
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy treatment in people with Sciatica Pain and Physical Therapy Modalities, run by Centro Universitário Augusto Motta.
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 1 inclusion and 3 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 Sep 2018. 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?
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?
Pain intensity (time frame: From enrollment to end of treatment at 12 weeks). 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?
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 Sep 2018.