Sciatic Leg PainNCT03144362
Neurodynamic Study
A study testing Bilateral Sliding Techniques and Unilateral Sliding Techniques in people with Sciatic Leg Pain, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg pain often have a poor recovery and some go onto have spinal surgery. However, in the absence of nerve root compression on MRI, no surgical option is viable and patients are often discharged and encouraged to self manage. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sciatic Leg Pain
- What is being tested?
- Bilateral Sliding Techniques and Unilateral Sliding Techniques
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to 31 Dec 2017
- 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 presenting with sciatic leg pain or dysaesthetic symptoms into one leg, below the knee who have had lumbar/sacral nerve root compression excluded through MRI
- Duration of symptoms greater than 12 weeks
- Reproduction of the patients symptoms with SLR test + passive ankle dorsiflexion
- Patients aged between 18-75 years of age (both male and female participants)
Who cannot join
- Any form of lower limb or spinal entrapment neuropathy
- Patients who have not had a lumbosacral MRI
- Any contraindications to manual therapy including; cancer, cauda equina syndrome, active inflammatory arthropathies, rapidly deteriorating neurology, spinal fracture
- Previous lumbar spinal surgery
- Inability to undertake side lying
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: Unilateral and Bilateral Neurodynamic Sliding Techniques as a Means of Treating Non-compressive Sciatic Leg Pain: A Pilot Study for a Randomised Controlled Trial
Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg pain often have a poor recovery and some go onto have spinal surgery. However, in the absence of nerve root compression on MRI, no surgical option is viable and patients are often discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with non-compressive leg pain. To date, there is no research exploring which form of neurodynamic sliding technique offers the greatest therapeutic benefit in patients presenting with sciatica. The aim of this pilot study is to calculate how many patients would be needed to run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the overall workability of the study and the feasibility of patient recruitment.
Read the detailed description
Patients who have given informed consent will be randomly allocated to one of three groups in a ratio of 1:1:1 (Control Group, Intervention Group 1, Intervention Group 2). Randomisation reduces selection bias and controls for unknown variables that may affect the outcome. Treatment allocation will occur through the use of sealed, opaque envelopes and will be implemented by the Graves Move More reception team as the patient attends the clinic. The reception staff will hand an opaque envelope to the subject for them to open. Randomisation undertaken by an independent third party improves internal validity. Patients will be treated according to the group they have been randomised to.
Data Collection, Analysis \& Statistical Opinion Prior to undertaking the study, baseline socio-demographic data will be recorded (E.g. age, sex, weight, height, occupation and duration of symptoms). Pre and posttest outcome data will also be recorded for the Roland-Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index 2.0 (ODI). Long-term data (I.e. 6-12 months post-treatment) will not be recorded as treatment effect is not being analysed as part of the pilot study.
- Conditions
- Sciatic Leg Pain
- Being tested
- Bilateral Sliding Techniques, Unilateral Sliding Techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Sliding TechniquesProcedure or surgery
Bilateral Sliding Techniques
Unilateral Sliding TechniquesProcedure or surgery
Unilateral Sliding Techniques
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Sliding Technique | Active comparator | Not described Receives: Procedure: Bilateral Sliding Techniques |
| Unilateral Sliding Techniques | Active comparator | Not described Receives: Procedure: Unilateral Sliding Techniques |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Questionnaire
The questionnaire will be completed prior to treatment starting and again at the conclusion of the study. Change scores will be recorded. Roland \& Fairbank (2000) advise a change score of 2-3 points on the 24-item version of the RMDQ as the minimally clinically important difference (MCID).
Measured: 6 months
Secondary outcomes (1)
The Oxford Disability Index
The Oxford Disability Index (ODI) accounts for the Roland Morris Disability Questionnaire shortcomings as it is more responsive to patients presenting with more chronic, and or severe disability (Roland \& Fairbank, 2000). The MCID for the ODI has been specified as 4 points (Co et al, 1993). Neither questionnaire require permission to be used in this trial Again, pre and post-test data will be recorded to calculate change scores.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startJan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatic Leg 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
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144362
- Sponsor's protocol ID
- STH19135
- Status last verified
- May 2018
- First submitted
- 4 May 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral and Bilateral Neurodynamic Sliding Techniques as a Means of Treating Non-compressive Sciatic Leg Pain: A Pilot Study for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03144362
- Acronym / sponsor ID
- STH19135
- Conditions
- Sciatic Leg Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 May 2017 (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.
Sciatica is a debilitating and costly condition. Prognostically, patients presenting with leg pain often have a poor recovery and some go onto have spinal surgery. However, in the absence of nerve root compression on MRI, no surgical option is viable and patients are often discharged and encouraged to self manage. Neurodynamics offers a means to treat patients with non-compressive leg pain. To date, there is no research exploring which form of neurodynamic sliding technique offers the greatest therapeutic benefit in patients presenting with sciatica. The aim of this pilot study is to calculate how many patients would be needed to run a full scale trial evaluating therapeutic efficacy. Moreover, the pilot will assess the overall workability of the study and the feasibility of patient recruitment.
Detailed description
Patients who have given informed consent will be randomly allocated to one of three groups in a ratio of 1:1:1 (Control Group, Intervention Group 1, Intervention Group 2). Randomisation reduces selection bias and controls for unknown variables that may affect the outcome. Treatment allocation will occur through the use of sealed, opaque envelopes and will be implemented by the Graves Move More reception team as the patient attends the clinic. The reception staff will hand an opaque envelope to the subject for them to open. Randomisation undertaken by an independent third party improves internal validity. Patients will be treated according to the group they have been randomised to.
Data Collection, Analysis \& Statistical Opinion Prior to undertaking the study, baseline socio-demographic data will be recorded (E.g. age, sex, weight, height, occupation and duration of symptoms). Pre and posttest outcome data will also be recorded for the Roland-Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index 2.0 (ODI). Long-term data (I.e. 6-12 months post-treatment) will not be recorded as treatment effect is not being analysed as part of the pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Sliding Technique | Active comparator | Procedure: Bilateral Sliding Techniques |
| Unilateral Sliding Techniques | Active comparator | Procedure: Unilateral Sliding Techniques |
| Standard care | No intervention | – |
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 presenting with sciatic leg pain or dysaesthetic symptoms into one leg, below the knee who have had lumbar/sacral nerve root compression excluded through MRI
- Duration of symptoms greater than 12 weeks
- Reproduction of the patients symptoms with SLR test + passive ankle dorsiflexion
- Patients aged between 18-75 years of age (both male and female participants)
Key exclusion criteria (6 listed)
- Any form of lower limb or spinal entrapment neuropathy
- Patients who have not had a lumbosacral MRI
- Any contraindications to manual therapy including; cancer, cauda equina syndrome, active inflammatory arthropathies, rapidly deteriorating neurology, spinal fracture
- Previous lumbar spinal surgery
- Inability to undertake side lying
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 |
|---|---|---|
| Bilateral Sliding TechniquesBilateral Sliding Techniques | Procedure or surgery | Bilateral Sliding Technique |
| Unilateral Sliding TechniquesUnilateral Sliding Techniques | Procedure or surgery | Unilateral Sliding Techniques |
Primary outcome
Roland Morris Disability Questionnaire
Time frame: 6 months
The questionnaire will be completed prior to treatment starting and again at the conclusion of the study. Change scores will be recorded. Roland \& Fairbank (2000) advise a change score of 2-3 points on the 24-item version of the RMDQ as the minimally clinically important difference (MCID).
1 secondary outcome
The Oxford Disability Index
Time frame: 6 months
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 31 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Sliding Techniques and Unilateral Sliding Techniques in people with Sciatic Leg Pain, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 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 31 May 2018. 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 United Kingdom. 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?
Roland Morris Disability Questionnaire (time frame: 6 months). 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 31 May 2018.