Physiotherapy for Sciatica; Is Earlier Better?

NCT02618278 | Completed Phase 3

• 1 other identifier: STH18420
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sciatica; Low Back Pain; Radiculopathy

Outcome Measures

Primary Outcomes (4)

• Ability to recruit patients

  Ability to recruit patients within the 26 week limit

  26 weeks

• 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

• Ability to initiate treatment

  Demonstrate the ability to organise physiotherapy appointments expeditiously

  2 weeks for intervention arm, 6 weeks for control

• Ensure patient safety

  Record all adverse and serious adverse events

  52 weeks

Secondary Outcomes (4)

• Oswestry Disability Index (ODI)

  Baseline, 6 weeks, 12 weeks, 26 weeks

• EQ5D-5L

  Baseline, 6 weeks, 12 weeks, 26 weeks

• Back & leg pain

  Baseline, 6 weeks, 12 weeks, 26 weeks

• Goal achievement

  26 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Physiotherapy OTHER

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.

Intervention; Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Reddington: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (2)

• 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.

  PMID: 30056385 DERIVED

• 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.

  PMID: 28259854 DERIVED

MeSH Terms

Conditions

Sciatica; Low Back Pain; Radiculopathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: NIHR Clinical Doctoral Research Fellow

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11