Physiotherapy for Sciatica; Is Earlier Better? (POLAR)
Primary Purpose
Sciatica, Low Back Pain, Radiculopathy
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Sciatica
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Usual care
Arm Description
Patients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy.
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.
Outcomes
Primary Outcome Measures
Ability to recruit patients
Ability to recruit patients within the 26 week limit
Patients willing to be randomised
The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.
Ability to initiate treatment
Demonstrate the ability to organise physiotherapy appointments expeditiously
Ensure patient safety
Record all adverse and serious adverse events
Secondary Outcome Measures
Oswestry Disability Index (ODI)
self-rated disability 0/100
EQ5D-5L
General health measurement
Back & leg pain
Self-reported back and leg pain
Goal achievement
Patient will rate whether their goal(s) have been achieved
Full Information
NCT ID
NCT02618278
First Posted
November 23, 2015
Last Updated
November 9, 2016
Sponsor
Michael Reddington
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02618278
Brief Title
Physiotherapy for Sciatica; Is Earlier Better?
Acronym
POLAR
Official Title
Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Reddington
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica, Low Back Pain, Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability to recruit patients
Description
Ability to recruit patients within the 26 week limit
Time Frame
26 weeks
Title
Patients willing to be randomised
Description
The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.
Time Frame
26 weeks
Title
Ability to initiate treatment
Description
Demonstrate the ability to organise physiotherapy appointments expeditiously
Time Frame
2 weeks for intervention arm, 6 weeks for control
Title
Ensure patient safety
Description
Record all adverse and serious adverse events
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
self-rated disability 0/100
Time Frame
Baseline, 6 weeks, 12 weeks, 26 weeks
Title
EQ5D-5L
Description
General health measurement
Time Frame
Baseline, 6 weeks, 12 weeks, 26 weeks
Title
Back & leg pain
Description
Self-reported back and leg pain
Time Frame
Baseline, 6 weeks, 12 weeks, 26 weeks
Title
Goal achievement
Description
Patient will rate whether their goal(s) have been achieved
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30056385
Citation
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.
Results Reference
derived
PubMed Identifier
28259854
Citation
Reddington 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.
Results Reference
derived
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Physiotherapy for Sciatica; Is Earlier Better?
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