SciaticaPhase 3POLARNCT02618278
Physiotherapy for Sciatica; Is Earlier Better?
A Phase 3 study testing Physiotherapy in people with Sciatica and Low Back Pain, run by Michael Reddington.
Trial summary
This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatica, Low Back Pain, Radiculopathy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Nov 2016
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 18-70 years of age with unilateral LRS defined as pain and or sensory disturbance and or weakness in a dermatomal and or myotomal distribution.
Who cannot join
- Patients with bilateral LRS.
- Patients with 'red flag' signs and symptoms of potential serious pathology.
- Cancer at the time of the study.
- Proven vascular claudication.
- Cauda Equina Syndrome (CES).
- Spinal fracture within the last 3 months.
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- Chronic regional pain syndromes.
- Recent lower limb fracture.
- CVA with physical or psychiatric disability.
- Poor English skills (necessitating the use of an interpreter and invalidating outcomes measures-ODI).
- Other significant co-morbidities preventing regular attendance at physiotherapy clinics.
- Patients with significant mental health problems for which treatment adherence may be difficult or psychologically disabling.
About this study
Official title: Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?
This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.
Read the detailed description
Sciatica is a relatively common problem which is often caused by nerve compression or irritation due to a lower back (Lumbar) disc prolapse. The problem is likely to improve in time as the body heals itself. However, this can take many months or sometime years. Sciatica can be a very painful condition, it may cause pins and needles, numbness or weakness in the legs affected. This, can cause great difficulty for people carrying out normal day to day activities.
Physiotherapy is often used to help people with sciatica but in many places in the United Kingdom it can take many weeks or months to begin therapy.
This study aims to see if having physiotherapy at 2 weeks after the patient has seen their G.P helps them get back to normal day to day function. This will be compared with another group of patients who will have physiotherapy at the 'usual' time of around 6 weeks after they have seen their G.P.The investigators will also be interviewing participants for their views of sciatica and physiotherapy. Each patient will receive a goal orientated physiotherapy management programme with achievement of those goals acting as secondary outcomes. Primary outcomes are feasibility objectives including patient recruitment rates, acceptability of outcome measures and intervention and rates of adverse events.
This is a pilot study which means that the investigators won't be directly comparing the 2 groups, but seeing if doing a full-scale study in the future is going to be feasible.The investigators will do this by measuring several different things, such as whether patients want to take part in the study or not, whether the tests the investigators will perform are the right tests and to see if the patients and physiotherapists find the treatment useful.
- Conditions
- Sciatica, Low Back Pain, Radiculopathy
- Being tested
- Physiotherapy
- Medical subject headings
- Sciatica, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
The aims of physiotherapy are to promote physical and psychological health for the patient, and in doing so promote and improve function. In light of the evidence to suggest spontaneous resorption of the disc fragment occurs, physiotherapy provides support and guidance for the patient to manage their symptoms whilst resorption takes place. The physiotherapy regimen will be tailored to the individuals' requirements. It will be goal orientated, and assessed using a biopsychosocial approach based on 7 different elements; neurological dysfunction, motor control of movement of the lumbar spine and pelvis, movement restriction in the lumbar spine and pelvis, psychological barriers to recovery, advice and education, functional-based exercise and pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy. Receives: Other: Physiotherapy |
| Usual care | Active comparator | Patients randomised to usual care will receive the same individual, goal-orientated physiotherapy management as the intervention arm but at 6 weeks post G.P referral, as is usual care. Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to recruit patients
Ability to recruit patients within the 26 week limit
Measured: 26 weeks
Patients willing to be randomised
The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.
Measured: 26 weeks
Ability to initiate treatment
Demonstrate the ability to organise physiotherapy appointments expeditiously
Measured: 2 weeks for intervention arm, 6 weeks for control
Ensure patient safety
Record all adverse and serious adverse events
Measured: 52 weeks
Secondary outcomes (4)
Oswestry Disability Index (ODI)
self-rated disability 0/100
Measured: Baseline, 6 weeks, 12 weeks, 26 weeks
EQ5D-5L
General health measurement
Measured: Baseline, 6 weeks, 12 weeks, 26 weeks
Back & leg pain
Self-reported back and leg pain
Measured: Baseline, 6 weeks, 12 weeks, 26 weeks
Goal achievement
Patient will rate whether their goal(s) have been achieved
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Reddington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor-investigator, Michael Reddington, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618278
- Sponsor's protocol ID
- STH18420
- Acronym
- POLAR
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2015
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reddington M, Walters SJ, Cohen J, Baxter SK, Cole A. Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial. BMJ Open. 2018 Jul 28;8(7):e021631. doi: 10.1136/bmjopen-2018-021631.
PubMed 30056385Reddington M, Walters SJ, Cohen J, Baxter S. Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol. BMJ Open. 2017 Mar 3;7(3):e014422. doi: 10.1136/bmjopen-2016-014422.
PubMed 28259854
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?
- ClinicalTrials.gov ID
- NCT02618278
- Acronym / sponsor ID
- POLAR / STH18420
- Conditions
- Sciatica, Low Back Pain, Radiculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Michael ReddingtonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Dec 2015 (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 evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.
Detailed description
Sciatica is a relatively common problem which is often caused by nerve compression or irritation due to a lower back (Lumbar) disc prolapse. The problem is likely to improve in time as the body heals itself. However, this can take many months or sometime years. Sciatica can be a very painful condition, it may cause pins and needles, numbness or weakness in the legs affected. This, can cause great difficulty for people carrying out normal day to day activities.
Physiotherapy is often used to help people with sciatica but in many places in the United Kingdom it can take many weeks or months to begin therapy.
This study aims to see if having physiotherapy at 2 weeks after the patient has seen their G.P helps them get back to normal day to day function. This will be compared with another group of patients who will have physiotherapy at the 'usual' time of around 6 weeks after they have seen their G.P.The investigators will also be interviewing participants for their views of sciatica and physiotherapy. Each patient will receive a goal orientated physiotherapy management programme with achievement of those goals acting as secondary outcomes. Primary outcomes are feasibility objectives including patient recruitment rates, acceptability of outcome measures and intervention and rates of adverse events.
This is a pilot study which means that the investigators won't be directly comparing the 2 groups, but seeing if doing a full-scale study in the future is going to be feasible.The investigators will do this by measuring several different things, such as whether patients want to take part in the study or not, whether the tests the investigators will perform are the right tests and to see if the patients and physiotherapists find the treatment useful.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: PhysiotherapyPatients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy. |
| Usual care | Active comparator | Other: PhysiotherapyPatients randomised to usual care will receive the same individual, goal-orientated physiotherapy management as the intervention arm but at 6 weeks post G.P referral, as is usual care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18-70 years of age with unilateral LRS defined as pain and or sensory disturbance and or weakness in a dermatomal and or myotomal distribution.
Key exclusion criteria (12 listed)
- Patients with bilateral LRS.
- Patients with 'red flag' signs and symptoms of potential serious pathology.
- Cancer at the time of the study.
- Proven vascular claudication.
- Cauda Equina Syndrome (CES).
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 |
|---|---|---|
| PhysiotherapyThe aims of physiotherapy are to promote physical and psychological health for the patient, and in doing so promote and improve function. In light of the evidence to suggest spontaneous resorption of the disc fragment occurs, physiotherapy provides support and guidance for the patient to manage their symptoms whilst resorption takes place. The physiotherapy regimen will be tailored to the individuals' requirements. It will be goal orientated, and assessed using a biopsychosocial approach based on 7 different elements; neurological dysfunction, motor control of movement of the lumbar spine and pelvis, movement restriction in the lumbar spine and pelvis, psychological barriers to recovery, advice and education, functional-based exercise and pain. | Other | Intervention, Usual care |
Primary outcome
Ability to recruit patients
Time frame: 26 weeks
Ability to recruit patients within the 26 week limit
Patients willing to be randomised
Time frame: 26 weeks
The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.
Ability to initiate treatment
Time frame: 2 weeks for intervention arm, 6 weeks for control
Demonstrate the ability to organise physiotherapy appointments expeditiously
Ensure patient safety
Time frame: 52 weeks
Record all adverse and serious adverse events
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks
EQ5D-5L
Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks
Back & leg pain
Time frame: Baseline, 6 weeks, 12 weeks, 26 weeks
Goal achievement
Time frame: 26 weeks
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 2016.
- Derived from this study: PubMed 30056385Reddington M, Walters SJ, Cohen J, Baxter SK, Cole A. Does early intervention improve outcomes in the physiotherapy management of lumbar radicular syndrome? Results of the POLAR pilot randomised controlled trial. BMJ Open. 2018 Jul 28;8(7):e021631. doi: 10.1136/bmjopen-2018-021631.
- Derived from this study: PubMed 28259854Reddington M, Walters SJ, Cohen J, Baxter S. Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol. BMJ Open. 2017 Mar 3;7(3):e014422. doi: 10.1136/bmjopen-2016-014422.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physiotherapy in people with Sciatica and Low Back Pain, run by Michael Reddington.
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 12 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 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ability to recruit patients (time frame: 26 weeks). The study lists 4 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 NCT02618278, which also lists 2 linked publications.
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 2016.