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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
Michael Reddington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 23, 2015
    Last Updated
    November 9, 2016
    Sponsor
    Michael Reddington
    Collaborators
    National Institute for Health Research, United Kingdom
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    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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