Condition category
Musculoskeletal Diseases
Date applied
05/02/2020
Date assigned
10/02/2020
Last edited
10/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A large percentage of people with low back pain, also complain of sciatica. Sciatica is pain that spreads down one leg from the lower back and buttocks. Usually, the pain extends below the knee sometimes to the foot and there may also be tingling or numbness of the skin.

The cause of sciatica varies and may be due to problems with the spine. Finding the cause of sciatica often involves the use of expensive imaging methods (magnetic resonance imaging) which can be misleading. Therefore research is increasingly focused on exploring more effective evaluation tools to categorize these patients with the aim of selecting the most appropriate technique for their treatment.

In the international physiotherapy community, some evaluation tools for sciatica have been proposed, but in Greece, no such study has ever been performed. This study aims to collect knowledge of the evaluation and categorization of patients with sciatica, with the hope of enhancing the quality of physiotherapy services and alleviating the symptoms of suffering patients.

Who can participate?
Adults aged 18 and above, who are referred from their spine specialist with sciatica or suspected sciatica. They must also have a mobile phone that can receive and send SMS texts or have access to a landline telephone, they must be willing to participate and the must understand to read and speak Greek

What does the study involve?
Patients referred with sciatica will be assessed from a specialist physiotherapist in order to categorize their symptoms and develop a method for classification in the greek health system

What are the possible benefits and risks of participating?
There are no risks involved in this research. The patients will not receive any treatment only standard clinical assessments and they will be asked to fill in some self-reported questionnaires

Where is the study run from?
The University of West Attica (Greece)

When is the study starting and how long is it expected to run for?
February 2019 to March 2022

Who is funding the study?
The University of West Attica (Greece)

Who is the main contact?
1. Nikolaos Kontakiotis PhD Cand, MSc, MMACP, MCSP
kontak766@hotmail.com
2. Prof. Georgios Gioftsos
gioftsos@uniwa.gr

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nikolaos Kontakiotis

ORCID ID

Contact details

Athens physio clinic
86 Imittou street
Pagrati
Athens
11634
Greece
+30 6972157943
kontak766@hotmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2604 4/2/2020

Study information

Scientific title

Investigation into the distinct clinical characteristics of people with sciatica in order to develop an algorithm for their classification in the Greek health system

Acronym

Sciatica classification algorithm

Study hypothesis

Can the evaluation tools of sciatica develop a reliable categorization algorithm for patients suffering from sciatica in order to find better treatment in the primary Greek health system?

Ethics approval

Pending as of 06/02/2020, Ethics and Deontology Committee of the University of West Attica (Agiou Spiridonos 28, Egaleo, Athens, Greece, 12243; adeltsidou@uniwa.gr), ref: 2604 4/2/2020

Study design

Single-blinded, observational epidemiological multicentre study for algorithm development

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Community

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Sciatica

Intervention

All patients will be informed about the purpose of this study by an information sheet and about the assessment that they will get for their symptoms. Before the start of the assessment, they will sign a consent form, ensuring their participation and anonymity. Their anonymity due to sensitive personal data will be secured during the study, but also after the publication of the results. Finally, they will be allowed to withdraw from the survey at any time they wish. Patients referred with sciatica from spine specialists will be examined by a specialist musculoskeletal physiotherapist. The specialist musculoskeletal physiotherapist will be responsible for conducting all evaluation tests and recording all data. Initially, each patient will be evaluated to determine whether or not they will be accepted into the study by answering some simple questions that will confirm the study's eligibility criteria.

The assessment will have three parts. The order will be randomized in the below three parts:
1. Questionnaires
2. Neurologic examination
3. Neurodynamics
Patients will perform all three parts of the assessment with random order.

Questionnaires will be completed in the presence of the specialist musculoskeletal physiotherapist to avoid any confusion. The specialist musculoskeletal physiotherapist will perform the neurological examination and quantitative aesthetic tests with the tool kit to draw conclusions about the neurological dysfunction. The third part of the assessment will be the performance of the neurodynamics test in order to evaluate the symptoms of the patients. All data will be recorded in detail and carefully to be statistically analyzed when the necessary number of patients is collected in order to develop an algorithm subgrouping these patients to low, medium and high risk in the Greek health system.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Development of an algorithm to categorize patients as low, medium and high-risk based on their sciatica symptoms assessed by questionnaires, neurologic examination, and neurodynamics evaluation at baseline without follow up

Secondary outcome measures

1. Disability is measured using the Roland Morris Disability Questionnaire at baseline at baseline without follow up
2. Overall impact of sciatica symptoms is measured using the Sciatica Bothersomeness Index at baseline without follow up
3. Fear of movement is measured using Fear-Avoidance Beliefs Questionnaire at baseline without follow up
4. Anxiety and depression are measured using Hospital Anxiety and Depression Scale at baseline without follow up
5. Risk of poor outcome is measured using STarT Back Tool at baseline without follow up
6. Neuropathic pain scales are measured using S-LANSS at baseline without follow up
7. The Central Sensitisation Inventory (CSI) is a to identify patients who have symptoms that may be related to central sensitization (CS) or central sensitivity syndromes (CSS) at baseline without follow up
8. Pain assessed by Visual analog scale (VAS) at baseline without follow up
9. Quality of life with Short Form-36 (SF-36) at baseline without follow up
10. The functionality of the lower limps measured with Lower Extremity Functional Scale (LEFS) at baseline without follow up
11. The symptoms of the patients will be assessed from the neurodynamics tests (Slump, SLR, Femoral slump test) at baseline without follow up
12. Muscle strength from neurological examination at baseline without follow up
13. Reflexes from neurological examination at baseline without follow up
14. Quantitative sensory testing ( hot, cold, vibration, pinprick, light touch, discrimination points) at baseline without follow up

Overall trial start date

22/01/2019

Overall trial end date

22/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with sciatica diagnosed by spine specialist in a private or public hospital and referred to physiotherapy
2. Pain in the lumbar region that reflects at the lower extremity in either a dermatomal distribution or not
3. Subjective neurological symptoms in one lower extremity, such as numbness, tingling, burning, weight sensation and crippling pain
4. Aged 18-75 years old
5. Ablity to read and communicate in Greek
6. Willingness to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Suspected serious spinal pathology or clinical red-flags such as cauda equina syndrome, suspicion of spinal tumours, infection, fractures and inflammatory spondyloarthropathy
2. Previous lumbar spine surgery
3. Previous lower extremity surgery
4. Currently receiving ongoing care from or have been in consultation with a secondary care doctor or physiotherapist for the same problem in the last 3 months
5. Serious co-morbidity preventing them from attending the research clinic and/or undergoing assessment and interventions
6. Severe enduring mental health condition
7. Pregnancy
8. Current participation in any other research study because of symptoms of back and leg pain or sciatica
9. Scoliosis of the spine >10 degrees, as measured on an X-ray
10. Taking steroid medications to treat neurological symptoms during the research period

Recruitment start date

01/03/2020

Recruitment end date

01/03/2021

Locations

Countries of recruitment

Greece

Trial participating centre

Athens Physio clinic
86 Imittou street Pagrati
Athens
11634
Greece

Sponsor information

Organisation

University of West Attica

Sponsor details

Agiou Spiridonos 28
Egaleo
Athens
12243
Greece
+30 210 538 7485
physio@uniwa.gr

Sponsor type

University/education

Website

https://www.uniwa.gr/en/

Funders

Funder type

University/education

Funder name

University of West Attica

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A study protocol is not currently available online. At the end of data analysis, the results of the study will be published in international congress and electronic scientific journals.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Nikolaos Kontakiotis (kontak766@hotmail.com). Type of data: row data of primary and secondary outcome measures. Availability: from 01/12/2021. Access criteria: systematic reviews, quantitative synthesis for studies in the same scope of interest, peer review reasons. Consent from participants is obtained according to GDPR data protection.

Intention to publish date

01/03/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/02/2020: Trial’s existence confirmed by the University of West Attica.