Physiotherapy for Sciatica; Is Earlier Better?

Low Back Pain Clinical Trial

— POLAR  

Official title:

Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618278
• Other study ID #: STH18420
• Status: Completed
• Phase: Phase 3
• First received: November 23, 2015
• Last updated: November 9, 2016
• Start date: February 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical 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. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Radiculopathy
• Sciatica

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Michael Reddington	National Institute for Health Research, United Kingdom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to recruit patients	Ability to recruit patients within the 26 week limit	26 weeks	No
Primary	Patients willing to be randomised	The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.	26 weeks	No
Primary	Ability to initiate treatment	Demonstrate the ability to organise physiotherapy appointments expeditiously	2 weeks for intervention arm, 6 weeks for control	No
Primary	Ensure patient safety	Record all adverse and serious adverse events	52 weeks	No
Secondary	Oswestry Disability Index (ODI)	self-rated disability 0/100	Baseline, 6 weeks, 12 weeks, 26 weeks	No
Secondary	EQ5D-5L	General health measurement	Baseline, 6 weeks, 12 weeks, 26 weeks	No
Secondary	Back & leg pain	Self-reported back and leg pain	Baseline, 6 weeks, 12 weeks, 26 weeks	No
Secondary	Goal achievement	Patient will rate whether their goal(s) have been achieved	26 weeks	No