Clinical trial NCT02618278: Physiotherapy for Sciatica; Is Earlier Better?
Official title: Physiotherapy Management of Lumbar Radicular Syndrome; Does Early Intervention Improve Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sciatica
Low Back Pain
Radiculopathy
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2015-12-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ability to recruit patients
timeFrame: 26 weeks
measure: Patients willing to be randomised
timeFrame: 26 weeks
measure: Ability to initiate treatment
timeFrame: 2 weeks for intervention arm, 6 weeks for control
measure: Ensure patient safety
timeFrame: 52 weeks
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 6 weeks, 12 weeks, 26 weeks
measure: EQ5D-5L
timeFrame: Baseline, 6 weeks, 12 weeks, 26 weeks
measure: Back & leg pain
timeFrame: Baseline, 6 weeks, 12 weeks, 26 weeks
measure: Goal achievement
timeFrame: 26 weeks
Other outcomes:
Locations:
Study officials:
References:
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.
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.