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Physiotherapy for Sciatica; Is Earlier Better? (POLAR)

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ClinicalTrials.gov Identifier: NCT02618278
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : November 10, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Michael Reddington, Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Sciatica Low Back Pain Radiculopathy Other: Physiotherapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?
Study Start Date : February 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
Experimental: Intervention
Patients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy.
Other: Physiotherapy
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.

Active Comparator: Usual care
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.
Other: Physiotherapy
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 Measures :
  1. Ability to recruit patients [ Time Frame: 26 weeks ]
    Ability to recruit patients within the 26 week limit

  2. 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.

  3. Ability to initiate treatment [ Time Frame: 2 weeks for intervention arm, 6 weeks for control ]
    Demonstrate the ability to organise physiotherapy appointments expeditiously

  4. Ensure patient safety [ Time Frame: 52 weeks ]
    Record all adverse and serious adverse events


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 26 weeks ]
    self-rated disability 0/100

  2. EQ5D-5L [ Time Frame: Baseline, 6 weeks, 12 weeks, 26 weeks ]
    General health measurement

  3. Back & leg pain [ Time Frame: Baseline, 6 weeks, 12 weeks, 26 weeks ]
    Self-reported back and leg pain

  4. Goal achievement [ Time Frame: 26 weeks ]
    Patient will rate whether their goal(s) have been achieved



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Reddington, NIHR Clinical Doctoral Research Fellow, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02618278    
Other Study ID Numbers: STH18420
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Radiculopathy
Sciatica
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Neuralgia