Physiotherapy for Sciatica; Is Earlier Better?

Phase 3

Completed

• Conditions: Sciatica; Low Back Pain; Radiculopathy
• Interventions: Other: Physiotherapy

• Registration Number: NCT02618278
• Lead Sponsor: Michael Reddington

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.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Study Start: 2016-02
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Physiotherapy	Patients randomised to the intervention arm will receive a individual, goal -orientated physiotherapy management package within 2 weeks G.P referral for physiotherapy.
Usual care	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.

Primary Outcome Measures

Name	Time	Method
Patients willing to be randomised	26 weeks	The willingness of patients to be randomised will be collected together with reasons for not wanting to be randomised.
Ability to recruit patients	26 weeks	Ability to recruit patients within the 26 week limit
Ability to initiate treatment	2 weeks for intervention arm, 6 weeks for control	Demonstrate the ability to organise physiotherapy appointments expeditiously
Ensure patient safety	52 weeks	Record all adverse and serious adverse events

Secondary Outcome Measures

Name	Time	Method
EQ5D-5L	Baseline, 6 weeks, 12 weeks, 26 weeks	General health measurement
Back & leg pain	Baseline, 6 weeks, 12 weeks, 26 weeks	Self-reported back and leg pain
Oswestry Disability Index (ODI)	Baseline, 6 weeks, 12 weeks, 26 weeks	self-rated disability 0/100
Goal achievement	26 weeks	Patient will rate whether their goal(s) have been achieved